Document text
Page 1 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918918
Page 2 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
Sep/4/2020
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918919
Page 3 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10681111]
2.Birth Date: /1957
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918920
Page 4 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918921
Page 5 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918922
Page 6 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918923
Page 7 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918924
Page 8 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [70.9]
3.Unit: kg
4.Height: [149.9]
5.Unit: cm
6.Body Mass Index: [31.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918925
Page 9 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918926
Page 10 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [252643]
3.Randomization Group: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918927
Page 11 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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:
Sep/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZPM6]
5.bSample ID [BNZPM7]
5.cSample ID [BNZPM8]
5.dSample ID [BPHSG6]
5.eSample ID [BPHSG7]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918928
Page 12 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/4/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZPM4]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918929
Page 13 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/4/2020 16:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918930
Page 14 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918931
Page 15 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918932
Page 16 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918933
Page 17 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918934
Page 18 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/25/2020
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 [BNZPT8]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918935
Page 19 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/25/2020 16:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918936
Page 20 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918937
Page 21 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/27/2020
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 [BNZP7T]
5.bSample ID [BNVXJG]
5.cSample ID [BNVXJH]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918938
Page 22 of 175
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918939
Page 23 of 175
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: 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: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918940
Page 24 of 175
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918941
Page 25 of 175
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: 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: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918942
Page 26 of 175
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918943
Page 27 of 175
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: 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: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918944
Page 28 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918945
Page 29 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918946
Page 30 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918947
Page 31 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918948
Page 32 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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?
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918949
Page 33 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918950
Page 34 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918951
Page 35 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918952
Page 36 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918953
Page 37 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918954
Page 38 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918955
Page 39 of 175
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918956
Page 40 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918957
Page 41 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918958
Page 42 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 Swollen Cervical Ly
mph Nodes bilateral
Sep/5/2020
UNK:UNK NO
End Date Time:
Sep/7/2020 UN
K:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 Injection Site Pain Sep/5/2020
UNK:UNK NO
End Date Time:
Sep/7/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT
3 Sneezing Sep/5/2020
UNK:UNK NO
End Date Time:
Sep/7/2020 UN
K:UNK
Repeating
Pages
4.ADVERS
E EVENT
4 Rhinorrhea Sep/5/2020
UNK:UNK NO
End Date Time:
Sep/7/2020 UN
K:UNK
Repeating
Pages
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918959
Page 43 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 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)[Swollen Cervical Lymph Nodes bilateral]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918960
Page 44 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
12.Was a Non-Drug Treatment
given?NO
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918961
Page 45 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918962
Page 46 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 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)[Injection Site Pain]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918963
Page 47 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
12.Was a Non-Drug Treatment
given?NO
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918964
Page 48 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918965
Page 49 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 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)[Sneezing]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918966
Page 50 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
12.Was a Non-Drug Treatment
given?NO
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918967
Page 51 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918968
Page 52 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 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)[Rhinorrhea]
4.Start Date Time: Sep/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/7/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918969
Page 53 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
12.Was a Non-Drug Treatment
given?NO
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918970
Page 54 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918971
Page 55 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918972
Page 56 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918973
Page 57 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918974
Page 58 of 175
***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: 10681111 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: //
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918975
Page 59 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918976
Page 60 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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?
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918977
Page 61 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918978
Page 62 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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?
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918979
Page 63 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918980
Page 64 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918981
Page 65 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918982
Page 66 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10681111 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:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918983
Page 67 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918984
Page 68 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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?
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918985
Page 69 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918986
Page 70 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918987
Page 71 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918988
Page 72 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918989
Page 73 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918990
Page 74 of 175
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10681111 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 [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918991
Page 75 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918992
Page 76 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918993
Page 77 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918994
Page 78 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918995
Page 79 of 175
***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: 10681111 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: [ ]
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918996
Page 80 of 175
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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/27/2020
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918997
Page 81 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10681111 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
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918998
Page 82 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10681111 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 Jan-22-2021 12:11:06 (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.
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918999
Page 83 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-04-2020 16:58:15 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919000
Page 84 of 175
***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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-04-2020 17:20:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919001
Page 85 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919002
Page 86 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919003
Page 87 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919004
Page 88 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919005
Page 89 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919006
Page 90 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919007
Page 91 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919008
Page 92 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919009
Page 93 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-25-2020 17:12:28 (UTC-07:00)
Mountain Time (US & Canada)Post Menopause
Not Applicable
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919010
Page 94 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10681111 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 Jan-22-2021 12:11:06 (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-18-2020 12:22:12 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Nov-02-2020 18:28:11 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919011
Page 95 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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.
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919012
Page 96 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
Sep-04-2020
16:54:54
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020
16:54:54
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919013
Page 97 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020
16:56:31
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/4/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919014
Page 98 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020
16:21:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10681111Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020
16:21:31
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1957Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020
16:57:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919015
Page 99 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-04-2020
16:57:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020
16:57:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919016
Page 100 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-04-2020
16:58:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919017
Page 101 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
Sep-04-2020
16:59:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020
16:59:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020
16:59:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919018
Page 102 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
70.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2fdc\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-2021-5683-0919019
Page 103 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
149.9Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.6Initial Entry
7.a
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.3Initial Entry
090177e196ae2fdc\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-2021-5683-0919020
Page 104 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae2fdc\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-2021-5683-0919021
Page 105 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
17:00:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919022
Page 106 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919023
Page 107 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919024
Page 108 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020
17:01:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919025
Page 109 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020
17:01:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020
17:01:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
252643Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919026
Page 110 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
17:02:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
17:02:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
10:16:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-07-2020
01:07:07
(UTC-07:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919027
Page 111 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
17:02:15
(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-04-2020
17:02:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
10:16:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BNZPM
6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919028
Page 112 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-08-2020
10:16:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPM6Initial Entry
5.b
Date Location User Value Reason
Sep-08-2020
10:16:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BNZPM
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-08-2020
10:16:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPM7Initial Entry
5.c
Date Location User Value Reason
Sep-08-2020
10:16:51
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BNZPM
8Initial Entry
090177e196ae2fdc\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-2021-5683-0919029
Page 113 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Sep-08-2020
10:16:51
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPM8Initial Entry
5.d
Date Location User Value Reason
Oct-21-2020
15:01:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample I
D:BPHS
G6Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-21-2020
15:01:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHSG6Initial Entry
5.e
Date Location User Value Reason
Oct-21-2020
15:01:10ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample I BPHSInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919030
Page 114 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00)
Mountain Time
(US & Canada)D: G7
5.e Sample ID
Date Location User Value Reason
Oct-21-2020
15:01:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHSG7Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919031
Page 115 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
17:02:30
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
17:02:30
(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-08-2020
10:17:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-07-2020
01:07:48
(UTC-07:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919032
Page 116 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
17:02:30
(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-04-2020
17:02:30
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
10:17:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BNZPM
4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919033
Page 117 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-08-2020
10:17:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPM4Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919034
Page 118 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919035
Page 119 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 16:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
17:03:11
(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-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919036
Page 120 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-04-2020
17:03:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919037
Page 121 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
Sep-04-2020
17:03:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919038
Page 122 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-25-2020
17:11:45
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919039
Page 123 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
17:12:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020
17:12:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.7
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
17:12:12
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2fdc\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-2021-5683-0919040
Page 124 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(US & Canada)
2.a Temperature:
Date Location User Value Reason
Sep-25-2020
17:12:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020
17:12:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020
17:12:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fdc\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-2021-5683-0919041
Page 125 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2fdc\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-2021-5683-0919042
Page 126 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
090177e196ae2fdc\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-2021-5683-0919043
Page 127 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020
17:12:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-25-2020
17:12:28ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fdc\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-2021-5683-0919044
Page 128 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00)
Mountain Time
(US & Canada)
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919045
Page 129 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
17:12:45
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
17:12:45
(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-28-2020
11:39:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-26-2020
03:44:07
(UTC-07:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919046
Page 130 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
17:12:45
(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-25-2020
17:12:45
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
11:39:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BNZPT
8Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919047
Page 131 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-28-2020
11:39:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPT8Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919048
Page 132 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919049
Page 133 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 16:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919050
Page 134 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-25-2020
17:17:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919051
Page 135 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-31-2020
05:23:26
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-30-2020
11:45:00
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerQuery 1: Answere
dChanged data
per query
Oct-30-2020
02:55:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919052
Page 136 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
EOT to match
date of blood
sample
collection date
at visit 3.
Oct-28-2020
07:46:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Oct/27/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919053
Page 137 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020
07:46:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020
07:46:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020
07:46:49
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-28-2020
07:46:32
(UTC-07:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919054
Page 138 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-28-2020
07:46:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collecti
on:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020
07:46:49
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample I
D:BNZP7
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020
07:46:49
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNZP7TInitial Entry
5.b
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919055
Page 139 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-29-2020
13:20:08
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample I
D:BNVXJ
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
13:20:08
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNVXJGInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020
13:34:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample I
D:BNVXJ
HInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919056
Page 140 of 175
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
13:34:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNVXJHInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919057
Page 141 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-30-2020
11:44:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
11:44:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
11:44:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919058
Page 142 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919059
Page 143 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-18-2020
15:06:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919060
Page 144 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-18-2020
15:10:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919061
Page 145 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-18-2020
15:12:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919062
Page 146 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
15:05:02
(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
15:05:02
(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
Oct-21-2020
18:43:57
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-20-2020
17:15:59
(UTC-07:00)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answe
redTranscription
Error
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919063
Page 147 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time
(US & Canada)
Oct-20-2020
17:15:59
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Swollen Cervica
l Lymph Nodes
bilateralTranscription
Error
Oct-19-2020
23:23:21
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dClinQuery:
Swollen
Cervical
Lymph Nodes:
please Specify
whether
bilateral, left
or right
Oct-19-2020
19:39:17
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Candid
ateClinQuery:
Swollen
Cervical
Lymph Nodes:
please Specify
whether
bilateral, left
or right
Sep-23-2020
04:21:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Closed Response
satisfies query
Sep-21-2020
12:18:29
(UTC-07:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redNew
Information
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919064
Page 148 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time
(US & Canada)
Sep-21-2020
12:18:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Swollen Cervica
l Lymph NodesNew
Information
Sep-21-2020
09:35:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Opene
dClin: Please
clarify site of
the swollen
lymph node
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Swollen Lymph
NodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919065
Page 149 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020
15:05:02
(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
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae2fdc\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-2021-5683-0919066
Page 150 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-18-2020
15:05:02
(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
15:05:02
(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
15:05:02
(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
15:05:02ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\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-2021-5683-0919067
Page 151 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00)
Mountain Time
(US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020
15:05:02
(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
15:11:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-18-2020
15:11:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RECOVERED/
RESOLVEDTranscription
Error
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Swollen
Lymph Node:
Response to
"What was the
outcome of this
adverse event?"
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919068
Page 152 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
is 'Not
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVE
RED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020
15:05:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919069
Page 153 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
15:06:36
(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
15:06:36
(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
15:06:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site PainInitial Entry
4. Start Date Time:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919070
Page 154 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-18-2020
15:06:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-18-2020
15:06:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020
15:06:36
(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
090177e196ae2fdc\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-2021-5683-0919071
Page 155 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
15:06:36
(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
15:06:36
(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
15:06:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2fdc\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-2021-5683-0919072
Page 156 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020
15:06:36
(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
15:06:36
(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
15:06:36
(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
15:06:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae2fdc\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-2021-5683-0919073
Page 157 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
15:06:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919074
Page 158 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
15:10:10
(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
15:10:10
(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
Sep-18-2020
15:10:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SneezingInitial Entry
4. Start Date Time:
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0919075
Page 159 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-18-2020
15:10:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-18-2020
15:10:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020
15:10:10
(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
090177e196ae2fdc\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-2021-5683-0919076
Page 160 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
15:10:10
(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
15:10:10
(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-23-2020
04:14:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Closed Response
satisfies query
Sep-22-2020
13:18:23
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 Query 1: Answered Original value
is correct
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919077
Page 161 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(US & Canada)
Sep-21-2020
11:08:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Opened Clin: Please
clarify
causality in
light of
associated
AE, is another
cause
plausible?
Sep-18-2020
15:10:10
(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
15:10:10
(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
15:10:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919078
Page 162 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020
15:10:10
(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
15:10:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020
15:10:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\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-2021-5683-0919079
Page 163 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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
15:12:03
(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
15:12:03
(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
Sep-22-2020
21:37:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response
satisfies query
Sep-21-2020
12:17:30ACV0PFEINFP6000 Query 1: Answere
dOriginal value is
correct
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919080
Page 164 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00)
Mountain Time
(US & Canada)
Sep-21-2020
09:51:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Since
NASAL
CONGESTION
or RUNNY
NOSE is one of
the
CDC-defined
symptoms of
COVID-19 (see
protocol section
8.1), please
consider
whether this
symptom could
have been due to
COVID-19 and
should have
triggered a
potential illness
visit.
Sep-18-2020
15:12:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RhinorrheaInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919081
Page 165 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020
15:12:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/5/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-18-2020
15:12:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/7/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020
15:12:03
(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).
090177e196ae2fdc\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-2021-5683-0919082
Page 166 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-18-2020
15:12:03
(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
15:12:03
(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-23-2020
04:13:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Closed Response
satisfies query
Sep-21-2020
12:17:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value
is correct
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919083
Page 167 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-21-2020
11:08:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Juleen
GayedQuery 1: Opened Clin: Please
clarify
causality in
light of
associated
AE, is another
cause
plausible?
Sep-18-2020
15:12:03
(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
15:12:03
(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
15:12:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919084
Page 168 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020
15:12:03
(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
15:12:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020
15:12:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2fdc\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-2021-5683-0919085
Page 169 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-18-2020
12:22:12
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Dec/18/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919086
Page 170 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 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-18-2020
12:22:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-18-2020
12:22:25
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candid
ateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Dec-18-2020
12:22:25
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Participant is wil
ling to return for
Vaccination 3
Participant is:
eligible and N
OT confirmed
to have receiv
ed only placeInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919087
Page 171 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
bo at Vaccinat
ion 1/2
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919088
Page 172 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-18-2020
12:22:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Dec/18/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-18-2020
12:22:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
ASSESS ELIGIBI
LITY FOR ADDIT
IONAL VACCINA
TIONInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919089
Page 173 of 175
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020
11:44:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020
17:01:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-04-2020
16:59:14
(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-30-2020
11:44:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-04-2020
17:01:53ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919090
Page 174 of 175
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00)
Mountain Time
(US & Canada)
Sep-04-2020
16:59:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919091
Page 175 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10681111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020
18:28:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Andrew
GentryData Entry:
Click Here to EnableInitial Entry
090177e196ae2fdc\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919092