Document text
Page 1 of 282
***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: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918419
Page 2 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918420
Page 3 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10681079]
2.Birth Date: /1955
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:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918421
Page 4 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918422
Page 5 of 282
***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: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918423
Page 6 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918424
Page 7 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[rectovaginal fistula]
Start Date: Mar/9/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[mixed hyperlipidemia]
Start Date: Feb/18/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Crohn's Disease]
Start Date: UNK/UNK/1969
Ongoing: YES
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918425
Page 8 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [74.8]
3.Unit: kg
4.Height: [164.0]
5.Unit: cm
6.Body Mass Index: [27.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918426
Page 9 of 282
***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: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918427
Page 10 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [247855]
3.Randomization Group: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918428
Page 11 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP1D1R]
5.bSample ID [BP1D1S]
5.cSample ID [BP1D1T]
5.dSample ID [BPHS93]
5.eSample ID [BPHS94]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918429
Page 12 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP1D1N]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918430
Page 13 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 16:37
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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918431
Page 14 of 282
***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: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918432
Page 15 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918433
Page 16 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918434
Page 17 of 282
***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: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918435
Page 18 of 282
***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: 10681079 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/21/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNZPS0]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918436
Page 19 of 282
***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: 10681079 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/21/2020 17:04
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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918437
Page 20 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918438
Page 21 of 282
***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: 10681079 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/19/2020
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 [BNZP57]
5.bSample ID [BNZP58]
5.cSample ID [BNZP59]
5.dSample ID [BNVXDW]
5.eSample ID [BNVXDX]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918439
Page 22 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918440
Page 23 of 282
***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: 10681079 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 [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918441
Page 24 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918442
Page 25 of 282
***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: 10681079 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 [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918443
Page 26 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918444
Page 27 of 282
***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: 10681079 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 [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918445
Page 28 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918446
Page 29 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/12/2020
2.Date of First Symptom Started: Oct/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/14/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918447
Page 30 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918448
Page 31 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/13/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918449
Page 32 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/13/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Aptima SARS-COV-2 Assay]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918450
Page 33 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
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: 10681079 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW83697]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918451
Page 34 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[self swab was collected and shipped, subject was not seen on site.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918452
Page 35 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918453
Page 36 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918454
Page 37 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918455
Page 38 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918456
Page 39 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918457
Page 40 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918458
Page 41 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918459
Page 42 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918460
Page 43 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918461
Page 44 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918462
Page 45 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918463
Page 46 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918464
Page 47 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918465
Page 48 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918466
Page 49 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918467
Page 50 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1. Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918468
Page 51 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918469
Page 52 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918470
Page 53 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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.Start Date: //
6.Ongoing?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918471
Page 54 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918472
Page 55 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918473
Page 56 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918474
Page 57 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/1/2021
2.Date of First Symptom Started: Jan/31/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/1/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918475
Page 58 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918476
Page 59 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Feb/1/202
1 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918477
Page 60 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/1/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918478
Page 61 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
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: 10681079 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_SELF
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW83669]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918479
Page 62 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[self swab done so not required]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918480
Page 63 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918481
Page 64 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918482
Page 65 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918483
Page 66 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918484
Page 67 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918485
Page 68 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918486
Page 69 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918487
Page 70 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918488
Page 71 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918489
Page 72 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918490
Page 73 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918491
Page 74 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918492
Page 75 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918493
Page 76 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918494
Page 77 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918495
Page 78 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1. Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918496
Page 79 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918497
Page 80 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918498
Page 81 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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.Start Date: //
6.Ongoing?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918499
Page 82 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918500
Page 83 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918501
Page 84 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918502
Page 85 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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:
Nov/9/2020
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 [BNZP89]
5.bSample ID [BNVXK6]
5.cSample ID [BNVXK7]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918503
Page 86 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918504
Page 87 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918505
Page 88 of 282
***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: 10681079 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/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918506
Page 89 of 282
***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: 10681079 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: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918507
Page 90 of 282
***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: 10681079 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:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918508
Page 91 of 282
***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: 10681079 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 [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918509
Page 92 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Muscle aches Sep/21/2020
23:00 NO
End Date Time:
Sep/22/2020 12:00
Repeating
Pages
2.ADVERSE E
VENT 2 Headache Sep/22/2020
10:30 NO
End Date Time:
Sep/22/2020 12:00
Repeating
Pages
3.ADVERSE E
VENT 3 Suspected bacterial m
eningitis Feb/6/2021 0
8:54 NO
End Date Time:
Feb/20/2021 UNK:UN
K
Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918510
Page 93 of 282
***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: 10681079 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)[Muscle aches]
4.Start Date Time: Sep/21/2020 23:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/22/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
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(b) (4)
FDA-CBER-2021-5683-0918511
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***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
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(b) (4)
FDA-CBER-2021-5683-0918512
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***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: 10681079 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)[Headache]
4.Start Date Time: Sep/22/2020 10:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/22/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918513
Page 96 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918514
Page 97 of 282
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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)[Suspected bacterial meningitis]
4.Start Date Time: Feb/6/2021 08:54
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/20/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918515
Page 98 of 282
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[suspected secondary to pyelonephritis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021132870]
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(b) (4)
FDA-CBER-2021-5683-0918516
Page 99 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category Medication ErrorStart D
ateIs the medication err
or Still OngoingStudy Medication
Errors ActionForm Instan
ce
1.MEDICATIO
N ERROR administered incorrect do
sage at vaccination 1 Aug/31
/2020 NO
End Date:
Aug/31/2020
NO ACTION TA
KEN Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918517
Page 100 of 282
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Medication Error
1.Category: MEDICATION ERROR
2.Medication Error (Type of
Medication Error):[administered incorrect dosage at vaccination 1]
3.Start Date: Aug/31/2020
4.Is the medication error still
ongoing?NO
End Date:
Aug/31/2020
5.Latest Action Taken with Study
Treatment:NO ACTION TAKEN
6.Was a Concomitant Medication
given?NO
7.Was a Non-Drug Treatment
given?NO
8.Did the Medication Error cause
the subject to be discontinued
from the study?NO
9.Was this medication error
associated with any adverse
events?NO
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918518
Page 101 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918519
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***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: 10681079 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: //
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918520
Page 103 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918521
Page 104 of 282
***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: 10681079 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?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918522
Page 105 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0918523
Page 106 of 282
***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: 10681079 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?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918524
Page 107 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918525
Page 108 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918526
Page 109 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918527
Page 110 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918528
Page 111 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918529
Page 112 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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?
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918530
Page 113 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918531
Page 114 of 282
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918532
Page 115 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918533
Page 116 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918534
Page 117 of 282
***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: 10681079 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 [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918535
Page 118 of 282
***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: 10681079 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 [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918536
Page 119 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918537
Page 120 of 282
***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: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918538
Page 121 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918539
Page 122 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918540
Page 123 of 282
***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: 10681079 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: [ ]
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918541
Page 124 of 282
***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: 10681079 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/19/2020
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918542
Page 125 of 282
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918543
Page 126 of 282
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andrew
Gentry Approved Mar-10-2021 07:35:10 (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.
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918544
Page 127 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-01-2020 16:54:44 (UTC-07:00)
Mountain Time (US & Canada)Emily
AnglemyerNot Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918545
Page 128 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918546
Page 129 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918547
Page 130 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918548
Page 131 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918549
Page 132 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918550
Page 133 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918551
Page 134 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918552
Page 135 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918553
Page 136 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-01-2020 16:58:46 (UTC-07:00)
Mountain Time (US & Canada)Emily
Anglemyerpost menopausal
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918554
Page 137 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918555
Page 138 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918556
Page 139 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918557
Page 140 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918558
Page 141 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918559
Page 142 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918560
Page 143 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918561
Page 144 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918562
Page 145 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-22-2020 10:30:19 (UTC-07:00)
Mountain Time (US & Canada)post menopause since 2007
Not Applicable
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918563
Page 146 of 282
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Andrew
Gentry Approved Mar-10-2021 07:35:10 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Michaela
ODonoghue N/A Feb-08-2021 15:42:06 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Jan-22-2021 12:05:46 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Emily
Anglemyer N/A Dec-17-2020 16:02:39 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918564
Page 147 of 282
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
N/A
Andrew
Gentry Approved Nov-09-2020 18:03:39 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Michaela
ODonoghue N/A Nov-09-2020 11:34:36 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Oct-29-2020 18:04:37 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Michaela
ODonoghue N/A Oct-29-2020 18:03:32 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Oct-26-2020 15:34:25 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918565
Page 148 of 282
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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.
Michaela
ODonoghue N/A Oct-20-2020 12:05:22 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Oct-16-2020 20:17:36 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AndrewGentry, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Michaela
ODonoghue N/A Oct-16-2020 09:08:12 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Andrew
Gentry Approved Oct-15-2020 15:01:38 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918566
Page 149 of 282
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 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.
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918567
Page 150 of 282
***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: 10681079 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-01-2020 16:53:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020 16:53:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918568
Page 151 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 16:53:38
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
OBTAINED
Date Written Consent Obta
ined
Aug/31/2020Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918569
Page 152 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 16:53:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10681079Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 16:53:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 16:53:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 16:53:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH O
RIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 16:53:51
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
WHITEInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918570
Page 153 of 282
***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: 10681079 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-01-2020 16:54:37
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/31/2020Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918571
Page 154 of 282
***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: 10681079 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-01-2020 16:55:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 16:55:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 16:55:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
COMPLETEDInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918572
Page 155 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 16:56:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:rectovaginal f
istula
Start Date: Mar/9/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 16:56:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 16:56:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
rectovaginal fistulaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 16:56:09
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Mar/9/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918573
Page 156 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-04-2020 12:29:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-04-2020 11:59:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerQuery 1: Answered only slight
indication that this
is happening. there
has been no
change in therapy,
hospitalization, or
change in
condition.
Sep-02-2020 09:09:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened GPD Clin: Please
confirm that
rectovaginal fistula
is ongoing since
2020/03/09 and
that disease did not
require significant
change in therapy
or hospitalization
for worsening
disease during the
6 weeks before
enrolment.
Sep-01-2020 16:56:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-01-2020 16:56:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:mixed hyperli
pidemia
Start Date: Feb/18/2020
Ongoing: YESInitial Entry
090177e196ae2fdf\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-2021-5683-0918574
Page 157 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 16:56:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-16-2021 17:03:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-16-2021 11:17:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueQuery 1: Answered Changed data per
query
Feb-11-2021 14:12:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical On
review of the
SAE report for
Meningitis, Med
Hx of Crohn's
disease (from
1969) was
reported, yet it
does not appear
on CRF. Please
review for
clinical relevance
to SAE safety
event (infection)
& report on Med
Hx CRF.
Feb-10-2021 20:22:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Candidate Clinical On
review of the
SAE report for
Meningitis, Med
Hx of Crohn's
disease (from
090177e196ae2fdf\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-2021-5683-0918575
Page 158 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1969) was
reported, yet it
does not appear
on CRF. Please
review for
clinical relevance
to SAE safety
event (infection)
& report on Med
Hx CRF.
Sep-01-2020 16:56:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily Anglemyer Data Entry:
mixed hyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 16:56:44
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Feb/18/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 16:56:44
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Feb-17-2021
07:55:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Crohn's D
iseaseTranscription
Error
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918576
Page 159 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date: UNK/UN
K/1969
Ongoing: YES
Feb-16-2021
17:48:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Crhon's D
isease
Start Date: UNK/UN
K/1969
Ongoing: YESTranscription
Error
Feb-16-2021
11:17:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Chron's D
isease
Start Date: UNK/UN
K/1969
Ongoing: YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918577
Page 160 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Feb-16-2021 11:17:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-17-2021
14:30:53
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Clos
edResponse
satisfies query
Feb-17-2021
07:55:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredTranscription
Error
Feb-17-2021
07:55:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Michaela
ODonoghueData E
ntry:
Crohn's
DiseaseTranscription
Error
Feb-17-2021
07:25:39
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Open
edClinical please
update typo for
CROHN's
disease
Feb-16-2021
19:45:09
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Clos
edDiscrepancy has
been closed.
090177e196ae2fdf\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-2021-5683-0918578
Page 161 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada)
Feb-16-2021
17:48:53
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription
Error
Feb-16-2021
17:48:53
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Michaela
ODonoghueData E
ntry:
Crhon's
DiseaseTranscription
Error
Feb-16-2021
13:56:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Open
edClarify
CHRON'S
DISEASE as
follows...Should
the spelling be
CROHN'S
DISEASE? If
so, edit.
Otherwise
clarify. Thank
you.
Feb-16-2021
11:17:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Michaela
ODonoghueData E
ntry:
Chron's
DiseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Feb-16-2021 11:17:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
UNK/UNK/1969Initial Entry
1.c Ongoing:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918579
Page 162 of 282
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Feb-16-2021 11:17:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918580
Page 163 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
74.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
164.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &ACV0PFEINFP6000 Emily
AnglemyerData Entry:
cmInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918581
Page 164 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada)
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.8Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Record Identifi
er::1
Temperature: 98.4
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918582
Page 165 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 16:58:01
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
ORAL CAVITYInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918583
Page 166 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918584
Page 167 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mountain Time (US &
Canada)
6.a
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sponsor-Define
d Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918585
Page 168 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
6.a Not Done:
Date Location User Value Reason
Sep-01-2020 16:58:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Not ApplicableInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918586
Page 169 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 17:00:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 17:00:26
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
247855Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918587
Page 170 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 17:00:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 17:00:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 04:53:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 2: Deleted 2 serum barcodes
updated.
Oct-21-2020 09:29:43
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 2: Candidate DM: Site request
to update form.
Do not issue
query. Once
updates are made
form can be
re-locked.
Sep-01-2020 17:00:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 17:00:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0918588
Page 171 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
entered. Please
review and
correct as
appropriate.
Sep-01-2020 17:00:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 17:00:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D1RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 17:00:58
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D1RInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 17:01:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D1SInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918589
Page 172 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 17:01:08
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D1SInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 17:01:17
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D1TInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 17:01:17
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D1TInitial Entry
5.d
Date Location User Value Reason
Oct-21-2020 14:41:56
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BPHS93Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-21-2020 14:41:56
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHS93Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918590
Page 173 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.e
Date Location User Value Reason
Oct-21-2020 14:42:04
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BPHS94Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-21-2020 14:42:04
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BPHS94Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918591
Page 174 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 17:01:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 17:01:31
(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-01-2020 17:01:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 17:01:31
(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-01-2020 17:01:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918592
Page 175 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-01-2020 17:01:50
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BP1D1NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 17:01:50
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BP1D1NInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918593
Page 176 of 282
***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: 10681079 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-01-2020 17:02:17
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Aug/31/2020 16:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918594
Page 177 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
6. Body Side:
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 17:02:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-01-2020 17:02:17
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918595
Page 178 of 282
***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: 10681079 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-01-2020 17:02:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918596
Page 179 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 12:30:17
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Closed Illness entere for
12/Oct
Oct-15-2020 06:17:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened RQ1: Previous
response states
‘subject was
contacted today,
12oct2020. will
follow up’. Please
confirm if the
Covid Illness visit
was done for
Illness eDiary
response on
06OCT2020.
Please update or
clarify.
Oct-13-2020 00:40:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:Candida
teAwaiting subject
confirmation
Oct-12-2020 13:13:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerQuery 1: Answered subject was
contacted today,
12oct2020. will
follow up.
Oct-09-2020 10:54:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have
you experienced
any of the
following?” for
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0918597
Page 180 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
the COVID-19
symptoms or
diagnosis on
06OCT2020. But
there is no
COVID Illness
visit reported in
the database.
Sep-22-2020 10:24:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918598
Page 181 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 10:27:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 10:27:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 99.1
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 10:27:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 10:27:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.1Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2fdf\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-2021-5683-0918599
Page 182 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-22-2020 10:27:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020 10:27:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918600
Page 183 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918601
Page 184 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-22-2020 10:30:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918602
Page 185 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 10:30:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 10:30:40
(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-22-2020 10:30:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 10:30:40
(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-22-2020 10:30:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918603
Page 186 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-22-2020 10:30:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNZPS0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 10:30:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNZPS0Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918604
Page 187 of 282
***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: 10681079 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-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020 17:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918605
Page 188 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-22-2020 10:31:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0918606
Page 189 of 282
***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: 10681079 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-20-2020 12:05:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Oct/19/2020Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918607
Page 190 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 12:08:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 12:08:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 12:09:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 12:08:45
(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.
Oct-20-2020 12:08:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918608
Page 191 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-20-2020 12:09:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sample ID: BNZP57Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 12:09:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
BNZP57Initial Entry
5.b
Date Location User Value Reason
Oct-20-2020 12:09:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sample ID: BNZP58Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 12:09:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
BNZP58Initial Entry
5.c
Date Location User Value Reason
Oct-20-2020 12:09:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sample ID: BNZP59Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918609
Page 192 of 282
***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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 12:09:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
BNZP59Initial Entry
5.d
Date Location User Value Reason
Oct-22-2020 10:40:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BNVXDWInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-22-2020 10:40:19
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNVXDWInitial Entry
5.e
Date Location User Value Reason
Oct-22-2020 10:40:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: BNVXDXInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-22-2020 10:40:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
BNVXDXInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918610
Page 193 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10681079 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-13-2020 14:00:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-13-2020 13:58:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form
is missing. Please
review and update
as appropriate.
Oct-13-2020 13:58:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in both
Nasal Swab Self
and Nasal Swab
are missing.
Please review and
update as
appropriate.
Oct-13-2020 13:58:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Oct/12/2020Initial Entry
3. COVID-19 Illness Visit:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918611
Page 194 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-13-2020 13:58:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0918612
Page 195 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Oct/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Oct/6/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-15-2020 12:26:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NO
Date of Last Symptom R
esolved:
Oct/14/2020New Information
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily Anglemyer Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Symptoms: FEVE
RInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918613
Page 196 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptom Present
:NO
4.a Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918614
Page 197 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.b Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918615
Page 198 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.c Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918616
Page 199 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.d Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918617
Page 200 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.e Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918618
Page 201 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.f Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918619
Page 202 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.g Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918620
Page 203 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.h Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Symptoms: VOMITI
NG
Symptom Pres
ent:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918621
Page 204 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.i Symptoms:
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-13-2020 14:00:05
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918622
Page 205 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Michaela
ODonoghueForm Created
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918623
Page 206 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Oct/13/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918624
Page 207 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
6. Trade Name:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-15-2020 12:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User ValueReason
Oct-16-2020
10:10:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse
satisfies query
Oct-16-2020
09:08:12
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dNew
Information
Oct-16-2020
09:08:12
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Michaela ODonoghue Data
Entry
:
Aptim
a SA
RS-C
OV-2
AssayNew
Information
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918625
Page 208 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-16-2020
07:33:57
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedsars-cov-2
rna,
qualitative
real time
rt-pcr is not
indicated on
the
FDA-cleared
(including
Emergency
Use
Authorization)
diagnostic list
and is not
indicated as
'CLIA-
certified lab'
or 'ISO 15189
accredited lab'
. Please verify
and update as
appropriate.
Otherwise,
please provide
clarification.
Oct-15-2020
12:31:33
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Michaela ODonoghue Data
Entry
:
SARS
-COV
-2 RN
A, Q
UALI
TATI
VE R
EAL
TIME
RT-P
CRInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918626
Page 209 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 14:00:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 14:00:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 14:24:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 14:00:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-13-2020 14:00:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918627
Page 210 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - 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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-13-2020 14:24:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Sample ID: RW83697Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 14:24:23
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
RW83697Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918628
Page 211 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 14:24:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 14:24:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 02:48:58
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-14-2020 12:35:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Oct-14-2020 04:26:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Thanks for
response.
According to
protocol 'If no
sample was
collected or
sample was not
collected’, please
update the reason.
Else clarify.
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0918629
Page 212 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-13-2020 16:03:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerQuery 1: Answered not collected at
visit yet
Oct-13-2020 14:24:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample
Collected?' is
marked as No and
'If no sample was
collected or
sample was not
collected
according to
protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Oct-13-2020 14:24:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-14-2020 12:35:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
self swab was collected and shi
pped, subject was not seen on si
te.Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918630
Page 213 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Type of Practit
ioner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918631
Page 214 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Type of Prac
titioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918632
Page 215 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of V
isits or Contacts:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918633
Page 216 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Type of Prac
titioner:TELEPHON
E CONSULT
ATION
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918634
Page 217 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
TELEPHONE CONSULTA
TIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
Type of Practitioner
:OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918635
Page 218 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-13-2020 14:01:11
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918636
Page 219 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/12/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-13-2020 14:01:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-13-2020 14:01:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020 14:01:46
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Emily
AnglemyerData Entry:
1Initial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918637
Page 220 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021
00:14:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed This will be
checked post BLA
Mar-10-2021
07:29:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Emily Anglemyer Query 3: Answered Subject is out of
state until
2Apr21. The CRA
has been notified
that a
convalescent visit
will occur on that
date.
Mar-09-2021
03:32:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened PDQ:
Convalescent visit
is missing and
35+ days (36)
have passed since
COVID Illness
Visit. If visit
occurred record
data as a matching
CONVA visit; if
visit did not occur
attempt to
schedule visit
even if OOW and
obtain the
CONVA sample
else clarify.
Feb-08-2021
16:33:57
(UTC-07:00)
Mountain Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918638
Page 221 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada)
Feb-08-2021
16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-08-2021
16:28:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-08-2021
16:28:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Feb-08-2021
16:28:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Feb/1/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-08-2021 16:28:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_BInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918639
Page 222 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Feb/1/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Jan/31/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NO
Date of Last Symptom Re
solved:
Feb/1/2021Initial Entry
4.a
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Symptoms: FEVE
R
Symptom Present
:YESInitial Entry
4.a Symptoms:
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918640
Page 223 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sympto
ms:NEW OR INCR
EASED COUG
H
Sympto
m Presen
t:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918641
Page 224 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.b Symptoms:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NEW OR INCREASED C
OUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918642
Page 225 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.c Symptoms:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NEW OR INCREASED S
HORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Symptoms: CHILL
S
Symptom Presen
t:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918643
Page 226 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.d Symptoms:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sympto
ms:NEW OR INCR
EASED MUSCL
E PAIN
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918644
Page 227 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.e Symptoms:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SM
ELL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918645
Page 228 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.f Symptoms:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NEW LOSS OF TASTE O
R SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Sympto
ms:NEW OR INCR
EASED SORE T
HROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918646
Page 229 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.g Symptoms:
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NEW OR INCREASED S
ORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-08-2021 16:30:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Michaela
ODonoghueData Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e196ae2fdf\Final\Final On: 01-Apr-2021 03:54 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0918647
Page 230 of 282
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled
Visit on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1068 Site Name: (1068) Bozeman Health Clinical Research
Subject No: 10681079 Subjec
…[truncated]