Document text
Page 1 of 228
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 version06 OCT 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933897
Page 2 of 228
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/16/2020
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933898
Page 3 of 228
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11301081]
2.Birth Date: /1967
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0933899
Page 4 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933900
Page 5 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933901
Page 6 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933902
Page 7 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[History of Alcoholism]
Start Date: Mar/28/2000
Ongoing: NO
End Date:
Jun/13/2016
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Apr/1/2003
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Moderate Persistent Asthma]
Start Date: Sep/4/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cough]
Start Date: Jan/1/1982
Ongoing: YES
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933903
Page 8 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obstructive sleep apnea]
Start Date: Jun/8/2011
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LIPID METABOLISM DISORDER]
Start Date: Mar/26/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VASECTOMY]
Start Date: Dec/19/2002
Ongoing: NO
End Date:
Dec/19/2002
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Compression injury dorsum right fifth Carpometacarpal joint]
Start Date: Dec/3/2008
Ongoing: NO
End Date:
Dec/3/2009
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933904
Page 9 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[focal arthritis of dorsum right fifth Carpometacarpal joint]
Start Date: Dec/3/2008
Ongoing: NO
End Date:
Dec/3/2009
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933905
Page 10 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933906
Page 11 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [93.1]
3.Unit: kg
4.Height: [177.2]
5.Unit: cm
6.Body Mass Index: [29.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933907
Page 12 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [109109]
3.Randomization Group: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933908
Page 13 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BR8MVG]
5.bSample ID [BR8MVH]
5.cSample ID [BPHV1R]
5.dSample ID [BPHV1S]
5.eSample ID [BS6ZSG]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933909
Page 14 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BR8MTZ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933910
Page 15 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: Oct/16/2020 11:30
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
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933911
Page 16 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933912
Page 17 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933913
Page 18 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933914
Page 19 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BR8MXT]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933915
Page 20 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/6/2020 09:04
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
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933916
Page 21 of 228
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933917
Page 22 of 228
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0X8L]
5.bSample ID [BP0X8M]
5.cSample ID [BS701X]
5.dSample ID [BS701Y]
5.eSample ID [BS701Z]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933918
Page 23 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933919
Page 24 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/10/2021
2.Date of First Symptom Started: Feb/9/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/12/2021
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? NO
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? NO
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933920
Page 25 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933921
Page 26 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Colle
ctionSpecimen
TypeSpecimen Collection
LocationAssay Code and Des
criptionDevice Typ
eForm Instanc
e
1.Not Applicabl
e Not Applic
able Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933922
Page 27 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933923
Page 28 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/13/2021
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 [RW84037]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933924
Page 29 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 performed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933925
Page 30 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933926
Page 31 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933927
Page 32 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933928
Page 33 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933929
Page 34 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: 2
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933930
Page 35 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933931
Page 36 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933932
Page 37 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933933
Page 38 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933934
Page 39 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1. Sponsor-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933935
Page 40 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933936
Page 41 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933937
Page 42 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933938
Page 43 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933939
Page 44 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933940
Page 45 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyg
en)Form Instance
1. Repeating Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933941
Page 46 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933942
Page 47 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933943
Page 48 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933944
Page 49 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933945
Page 50 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933946
Page 51 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933947
Page 52 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP0XKJ]
5.bSample ID [BP0XL0]
5.cSample ID [BPHV8S]
5.dSample ID [BPHV8T]
5.eSample ID [BPHV8V]
5.fSample ID [BPHV8W]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933948
Page 53 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933949
Page 54 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933950
Page 55 of 228
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
1.ADVERSE
EVENT 1 swollen lymph node - rig
ht side of neck Feb/11/2021
16:00 NO
End Date Time:
Feb/12/2021 23:00
Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933951
Page 56 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[swollen lymph node - right side of neck]
4.Start Date Time: Feb/11/2021 16:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 23:00
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
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933952
Page 57 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
[unknown]
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[ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933953
Page 58 of 228
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933954
Page 59 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933955
Page 60 of 228
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933956
Page 61 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: //
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933957
Page 62 of 228
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933958
Page 63 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933959
Page 64 of 228
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933960
Page 65 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933961
Page 66 of 228
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933962
Page 67 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933963
Page 68 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933964
Page 69 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933965
Page 70 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933966
Page 71 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933967
Page 72 of 228
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933968
Page 73 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933969
Page 74 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933970
Page 75 of 228
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933971
Page 76 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933972
Page 77 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933973
Page 78 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933974
Page 79 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933975
Page 80 of 228
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933976
Page 81 of 228
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933977
Page 82 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933978
Page 83 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/28/2021
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933979
Page 84 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933980
Page 85 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/28/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933981
Page 86 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BP0XHD]
5.bSample ID [BP0XHF]
5.cSample ID [BPHV6S]
5.dSample ID [BPHV6T]
5.eSample ID [BPHV6V]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933982
Page 87 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BP0XH2]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933983
Page 88 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 14:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933984
Page 89 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933985
Page 90 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BP0XK2]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933986
Page 91 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 14:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933987
Page 92 of 228
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933988
Page 93 of 228
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933989
Page 94 of 228
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933990
Page 95 of 228
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933991
Page 96 of 228
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933992
Page 97 of 228
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933993
Page 98 of 228
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933994
Page 99 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/4/2020
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933995
Page 100 of 228
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933996
Page 101 of 228
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0933997
Page 102 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormOct-16-2020 10:41:52 (UTC-08:00)
Pacific Time (US & Canada)Tara Beatty Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0933998
Page 103 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormFeb-12-2021 10:32:14 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0933999
Page 104 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934000
Page 105 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934001
Page 106 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934002
Page 107 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
4Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934003
Page 108 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
5Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934004
Page 109 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
6Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934005
Page 110 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
7Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934006
Page 111 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
8Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934007
Page 112 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
9Feb-12-2021 10:32:14 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934008
Page 113 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormJan-28-2021 13:31:16 (UTC-08:00) Pacific
Time (US & Canada)Dorothy
KurdylaNot Applicable
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934009
Page 114 of 228
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-12-2021 16:26:03 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Feb-21-2021 16:46:00 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Kristi Bays N/A Feb-17-2021 06:54:04 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Feb-16-2021 11:24:01 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934010
Page 115 of 228
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, StephenFortmann, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-16-2021 09:59:42 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Feb-12-2021 17:09:53 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Tara Beatty N/A Feb-10-2021 15:31:34 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Jan-29-2021 11:55:56 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934011
Page 116 of 228
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Dorothy
Kurdyla N/A Jan-28-2021 13:30:57 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Jan-22-2021 22:25:07 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
Sperry
Robinson N/A Jan-22-2021 09:48:57 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen
Fortmann Approved Dec-04-2020 13:51:24 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934012
Page 117 of 228
***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, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, StephenFortmann, 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.
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934013
Page 118 of 228
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-16-2020 10:41:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-16-2020 10:41:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934014
Page 119 of 228
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-16-2020 10:41:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Oct/16/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934015
Page 120 of 228
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-16-2020 10:41:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11301081Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-16-2020 10:41:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-16-2020 10:41:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-16-2020 10:41:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-16-2020 10:41:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
WHITEInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934016
Page 121 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 10:41:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Oct/16/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934017
Page 122 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-16-2020 10:42:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 10:42:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 10:42:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
COMPLETEDInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934018
Page 123 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020 10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:History of Alc
oholism
Start Date: Mar/28/2000
Ongoing: NO
End Date:
Jun/13/201
6Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:45:06
(UTC-08:00) Pacific
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
Oct-16-2020 10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
History of AlcoholismInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020 10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Mar/28/2000Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934019
Page 124 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020 10:45:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NO
End Date:
Jun/13/2016Initial Entry
1.b
Date Location User Value Reason
Oct-16-2020 10:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Hypertens
ion
Start Date: Apr/1/200
3
Ongoing: YESInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934020
Page 125 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:45:30
(UTC-08:00) Pacific
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
Oct-16-2020 10:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020 10:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Apr/1/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020 10:45:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-16-2020 10:45:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Moderate Persi
stent Asthma
Start Date: Sep/4/2015Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934021
Page 126 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:45:56
(UTC-08:00) Pacific
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
Oct-16-2020 10:45:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Moderate Persistent AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020 10:45:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Sep/4/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-16-2020 10:45:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-16-2020 10:46:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934022
Page 127 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History T
erm:Cough
Start Date: Jan/1/19
82
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:46:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 10:46:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
CoughInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-16-2020 10:46:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Jan/1/1982Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-16-2020 10:46:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934023
Page 128 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Oct-22-2020
12:45:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
Line/MH N
umber:5
Medical Hi
story Term:obstructive
sleep apnea
Start Date: Jun/8/2011
Ongoing: YESTranscription
Error
Oct-19-2020
16:23:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:Obstructive
sleep apnea
Start Date: Jun/8/2011
Ongoing: YESre-typed. Unclear
what the error is.
Oct-19-2020
09:57:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:Obstructive
sleep apnea
Start Date: Jun/8/2011
Ongoing: YESChanged
Information
Oct-16-2020
15:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Line/MH N
umber:5
Medical Hi
story Term
:Obstructive
Sleep Apne
a
Start Date: Jun/8/2011
Ongoing: YESTranscription
Error
Oct-16-2020
10:46:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934024
Page 129 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical
History T
erm:OBSTRUCTI
VE SLEEP A
PNEA
Start Dat
e:Jun/8/2011
Ongoing: YES
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934025
Page 130 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:46:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020
21:01:33
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Clos
edResponse
satisfies query
Oct-22-2020
12:45:22
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
4: Ans
weredTranscription
Error
Oct-22-2020
12:45:22
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Dorothy
KurdylaData E
ntry:
obstruc
tive sle
ep apne
aTranscription
Error
Oct-22-2020
05:50:43
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
4: Ope
nedDM: A
carriage is
identified. To
avoid
processing
errors, please
remove the
identified
character by
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934026
Page 131 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
deleting the
entry and
re-entering the
data (without
using copy
and paste).
Oct-19-2020
22:36:19
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
3: Clos
edDiscrepancy
has been
closed.
Oct-19-2020
16:23:09
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredre-typed.
Unclear what
the error is.
Oct-19-2020
16:23:09
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Obstruc
tive sle
ep apne
are-typed.
Unclear what
the error is.
Oct-19-2020
14:51:02
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
3: Ope
nedSpecial
Characters:
Verbatim
Term contains
embedded
non-compliant
characters.
Oct-19-2020
12:44:15
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
2: Clos
edDiscrepancy
has been
closed.
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934027
Page 132 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Oct-19-2020
09:57:06
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredChanged
Information
Oct-19-2020
09:57:06
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Obstruc
tive sle
ep apne
aChanged
Information
Oct-16-2020
18:58:54
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
2: Ope
nedSpecial
Characters:
Verbatim
Term contains
embedded
non-compliant
characters.
Oct-16-2020
18:51:10
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clos
edDiscrepancy
has been
closed.
Oct-16-2020
15:23:30
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription
Error
Oct-16-2020
15:23:30
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Tara Beatty Data E
ntry:
Obstruc
tive Sle
ep Apn
eaTranscription
Error
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934028
Page 133 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Oct-16-2020
14:15:05
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Ope
nedSpecial
Characters:
Verbatim
Term contains
embedded
non-compliant
characters.
Oct-16-2020
10:46:52
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Tara Beatty Data E
ntry:
OBST
RUCTI
VE SL
EEP A
PNEAInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-16-2020 10:46:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Jun/8/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-16-2020 10:46:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-16-2020 10:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:6Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934029
Page 134 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Hi
story Term
:LIPID METAB
OLISM DISOR
DER
Start Date: Mar/26/2018
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 10:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
LIPID METABOLISM DIS
ORDERInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-16-2020 10:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Mar/26/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-16-2020 10:47:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934030
Page 135 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.g
Date Location User Value Reason
Oct-16-2020 10:47:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:VASECTO
MY
Start Date: Dec/19/200
2
Ongoing: NO
End Date:
Dec/19/
2002Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934031
Page 136 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:47:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 10:47:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
VASECTOMYInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-16-2020 10:47:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Dec/19/2002Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-16-2020 10:47:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NO
End Date:
Dec/19/2002Initial Entry
1.h
Date Location User Value Reason
Oct-19-2020
14:15:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
Line/
MH N
umber8Transcription
Error
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934032
Page 137 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
:
Medic
al Hist
ory Te
rm:Compression inju
ry dorsum right fi
fth Carpometacar
pal joint
Start
Date:Dec/3/2008
Ongoi
ng:NO
End Date:
Dec/3/2009
Oct-16-2020
15:24:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Line/M
H Num
ber:8
Medica
l Histor
y Term:Compression inj
ury dorsum right
5th CMC joint
Start D
ate:Dec/3/2008
Ongoin
g:NO
End Date:
Dec/3/2009Transcription
Error
Oct-16-2020
10:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:8
Medic
al Hist
ory Te
rm:Compression injur
y dorsum right 5th
CMC joint with fo
cal arthritis
Start
Date:Dec/3/2008Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934033
Page 138 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoi
ng:NO
End Date:
Dec/3/2009
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934034
Page 139 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Oct-16-2020 10:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Oct-19-2020
14:15:21
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Dorothy
KurdylaData
Entry
:
Comp
ressio
n inju
ry dor
sum ri
ght fif
th Car
pomet
acarp
al join
tTranscription
Error
Oct-16-2020
18:51:26
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Oct-16-2020
15:24:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Oct-16-2020 ACV0PFEINFP6000 Tara Beatty DataTranscription
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934035
Page 140 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
15:24:03
(UTC-08:00)
Pacific Time
(US &
Canada)Entry
:
Comp
ressio
n inju
ry dor
sum ri
ght 5t
h CM
C join
tError
Oct-16-2020
14:15:21
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple
concepts in the
term
COMPRESSION
INJURY
DORSUM
RIGHT 5TH
CMC JOINT
WITH FOCAL
ARTHRITIS.
Split the term
into
COMPRESSION
INJURY
DORSUM
RIGHT 5TH
CMC JOINT and
FOCAL
ARTHRITIS and
report as separate
entries. Thank
you.
Oct-16-2020
10:48:38
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Tara Beatty Data
Entry
:
Comp
ressio
n injuInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934036
Page 141 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
ry dor
sum ri
ght 5t
h CM
C join
t with
focal
arthrit
is
1.h Start Date:
Date Location User Value Reason
Oct-16-2020 10:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Dec/3/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-16-2020 10:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NO
End Date:
Dec/3/2009Initial Entry
1.i
Date Location User Value Reason
Oct-19-2020
14:15:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
Line/
MH N
umber
:9
Medic
al Hist
ory Te
rm:focal arthritis of
dorsum right fifth
Carpometacarpal
jointTranscription
Error
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934037
Page 142 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start D
ate:Dec/3/2008
Ongoi
ng:NO
End Date:
Dec/3/2009
Oct-16-2020
15:25:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Line/M
H Num
ber:9
Medical
History
Term:focal arthritis of
dorsum right 5th
CMC joint
Start D
ate:Dec/3/2008
Ongoin
g:NO
End Date:
Dec/3/2009Transcription
Error
Oct-16-2020
15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:9
Medical
History
Term:dorsum right 5th
CMC joint with
focal arthritis
Start D
ate:Dec/3/2008
Ongoin
g:NO
End Date:
Dec/3/2009Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934038
Page 143 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Oct-16-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
14:15:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
focal arthritis of dorsum ri
ght fifth Carpometacarpal
jointTranscription
Error
Oct-16-2020
15:25:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
focal arthritis of dorsum ri
ght 5th CMC jointTranscription
Error
Oct-16-2020
15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
dorsum right 5th CMC joi
nt with focal arthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-16-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Dec/3/2008Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-16-2020 15:24:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NO
End Date:Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934039
Page 144 of 228
***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Dec/3/2009
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934040
Page 145 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-16-2020 10:48:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934041
Page 146 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Oct/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
93.1Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
177.2Initial Entry
5. Unit:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934042
Page 147 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.6Initial Entry
7.a
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Record Identifi
er::1
Temperature: 98.3
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
FInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934043
Page 148 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 10:49:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934044
Page 149 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-16-2020 12:30:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
Oct/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-16-2020 12:30:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
109109Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934045
Page 150 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 10:55:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 10:55:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 10:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 10:55:09
(UTC-08:00) Pacific
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-16-2020 10:55:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi Bays Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934046
Page 151 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Oct-16-2020 10:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BR8MVGInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 10:55:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BR8MVGInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 10:55:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BR8MVHInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 10:55:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BR8MVHInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020 10:55:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BPHV1RInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934047
Page 152 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 10:55:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BPHV1RInitial Entry
5.d
Date Location User Value Reason
Oct-16-2020 10:55:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BPHV1SInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-16-2020 10:55:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BPHV1SInitial Entry
5.e
Date Location User Value Reason
Oct-16-2020 10:55:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BS6ZSGInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-16-2020 10:55:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BS6ZSGInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934048
Page 153 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 10:52:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 10:52:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 10:52:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 10:52:09
(UTC-08:00) Pacific
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-16-2020 10:52:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi Bays Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934049
Page 154 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Oct-16-2020 10:52:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BR8MTZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 10:52:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BR8MTZInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934050
Page 155 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
Oct/16/2020 11:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934051
Page 156 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D 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
Oct-16-2020 12:30:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
YESInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934052
Page 157 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-16-2020 12:30:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934053
Page 158 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 08:23:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Nov/6/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934054
Page 159 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Nov-06-2020 08:26:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Nov/6/2020Initial Entry
2.a
Date Location User Value Reason
Nov-06-2020 08:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Record Identifi
er::1
Temperature: 98.4
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-06-2020 08:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-06-2020 08:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934055
Page 160 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Nov-06-2020 08:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-06-2020 08:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934056
Page 161 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 08:23:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 08:23:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020
08:23:30 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020
08:23:17 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Nov-06-2020
08:23:17 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Kristi Bays Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934057
Page 162 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Nov-06-2020 08:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BR8MXTInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 08:23:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BR8MXTInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934058
Page 163 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-06-2020
13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-06-2020 13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-06-2020 13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-06-2020
13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
Nov/6/2020 09:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-06-2020 13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934059
Page 164 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
6. Body Side:
Date Location User Value Reason
Nov-06-2020
13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-06-2020 13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-06-2020 13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D 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
Nov-06-2020
13:10:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
YESInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934060
Page 165 of 228
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-04-2020 08:07:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Dec/4/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934061
Page 166 of 228
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020 11:02:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020 11:02:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-04-2020 11:02:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-04-2020 11:02:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Dec-04-2020 11:02:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/4/2020Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934062
Page 167 of 228
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Dec-04-2020 11:02:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0X8LInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020 11:02:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP0X8LInitial Entry
5.b
Date Location User Value Reason
Dec-04-2020 11:04:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0X8MInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020 11:04:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP0X8MInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020 11:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS701XInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0934063
Page 168 of 228
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Dec-04-2020 11:05:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS701XInitial Entry
5.d
Date Location User Value Reason
Dec-04-2020 11:05:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS701YInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-04-2020 11:05:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS701YInitial Entry
5.e
Date Location User Value Reason
Dec-04-2020 11:05:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS701ZInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-04-2020 11:05:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS701ZInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0934064
Page 169 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021
20:31:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-16-2021
10:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Feb-15-2021
15:06:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dPlease provide
the details of the
self swab once
received.
Feb-15-2021
09:24:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered self swab to be
performed on
2/13/21, but not
yet received in
lab for scanning.
Is it preferable to
add the expected
swab date or wait
until the self
swab is received
in the lab for
scanning?
Feb-15-2021
01:11:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit is
completed but
Date of
Collection in both
Nasal Swab Self
and Nasal Swab
are missing.
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934065
Page 170 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Please review and
update as
appropriate.
Feb-14-2021
22:47:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Feb-12-2021
10:34:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Changed data per
query
Feb-12-2021
10:34:03
(UTC-08:00) Pacific
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-11-2021
03:58:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Kindly
review and
complete ‘Health
Care Utilization,
Microbiology
Specimen, Illness
Details form' at
this visit. Thank
you.
Feb-11-2021
01:56:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Date of Visit is
completed but
Date of
Collection in both
Nasal Swab Self
and Nasal Swab
are missing.
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934066
Page 171 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Please review and
update as
appropriate.
Feb-10-2021
15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Feb-10-2021
15:31:33
(UTC-08:00) Pacific
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-10-2021
15:31:33
(UTC-08:00) Pacific
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-10-2021
15:31:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Feb/10/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-10-2021 15:31:33
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934067
Page 172 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934068
Page 173 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Feb/10/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Feb/9/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-18-2021
13:33:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
NO
Date of Last Symptom Re
solved:
Feb/12/2021New Information
Feb-10-2021
15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934069
Page 174 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.a Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934070
Page 175 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.c
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Sympt
oms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympt
om Pre
sent:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934071
Page 176 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.d Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934072
Page 177 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.e Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Presen
t:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934073
Page 178 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.f Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934074
Page 179 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.g Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
YESInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934075
Page 180 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
4.i
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-10-2021 15:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934076
Page 181 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934077
Page 182 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-12-2021
10:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934078
Page 183 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: 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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-16-2021 10:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-16-2021 10:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021
06:54:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-17-2021
04:57:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Feb-16-2021
10:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0934079
Page 184 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: 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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
correct as
appropriate.
Feb-16-2021
10:00:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/13/2021Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021 06:54:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: RW84037Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-17-2021 06:54:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
RW84037Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934080
Page 185 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-12-2021 10:34:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-12-2021 10:34:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-16-2021
23:07:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-16-2021
10:01:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-15-2021
15:04:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opene
dThe data has not
been updated on
the SELF SWAB
form within this
visit. Please
record the details
of the self swab
else clarify.
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934081
Page 186 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-15-2021
09:22:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-14-2021
21:58:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Per
comment Self
swab performed.
However, Self
Swab CRF is not
initiated. Kindly
review and update
the Self swab
details in the
corresponding
CRF. Thanks
Feb-12-2021
10:34:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-12-2021
10:34:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
self swab performedInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934082
Page 187 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:SPECI
ALIST
Occurrence of V
isits or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:EMERGE
NCY RO
OMInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934083
Page 188 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Occurrence of
Visits or Cont
acts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934084
Page 189 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSI
CIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:URGEN
T CAR
E
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934085
Page 190 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:TELEPHO
NE CONSU
LTATION
Occurrence
of Visits or
Contacts:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934086
Page 191 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULT
ATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitione
r:OTH
ER
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934087
Page 192 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-12-2021
10:31:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934088
Page 193 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/10/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-12-2021 10:33:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILL
NESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-12-2021
10:33:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021
10:33:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934089
Page 194 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 16:26:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/12/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-12-2021 16:26:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934090
Page 195 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021 16:26:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021 16:26:18
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
16:26:31 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-12-2021
16:26:18 (UTC-08:00)
Pacific 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.
Mar-12-2021
16:26:18 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934091
Page 196 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Mar-12-2021 16:26:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0XKJInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021 16:26:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP0XKJInitial Entry
5.b
Date Location User Value Reason
Mar-12-2021 16:26:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP0XL0Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021 16:26:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP0XL0Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021 16:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHV8SInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0934092
Page 197 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Mar-12-2021 16:27:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHV8SInitial Entry
5.d
Date Location User Value Reason
Mar-12-2021 16:27:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHV8TInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-12-2021 16:27:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHV8TInitial Entry
5.e
Date Location User Value Reason
Mar-12-2021 16:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHV8VInitial Entry
5.e Sample ID
Date Location User Value Reason
Mar-12-2021 16:27:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHV8VInitial Entry
5.f
Date Location User Value Reason
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0934093
Page 198 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/12/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-12-2021 16:27:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPHV8WInitial Entry
5.f Sample ID
Date Location User Value Reason
Mar-12-2021 16:27:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPHV8WInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934094
Page 199 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Feb-12-2021 14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934095
Page 200 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
swollen lymph node - right
side of neckInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021
13:33:03
(UTC-08:00) PacificACV0PFEINFP6000 Dorothy
KurdylaData Entry:
NO
End Date Time:New Information
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934096
Page 201 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
Feb/12/2021 23:00
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-17-2021
00:38:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-16-2021
09:59:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-16-2021
09:59:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
Feb-15-2021
21:50:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing. Kindly
review and
update.
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).
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934097
Page 202 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Feb-17-2021
00:39:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-16-2021
09:59:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-16-2021
09:59:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
Feb-15-2021
21:51:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for "Is
the adverse
event serious?"
is missing.
Kindly review
and update.
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-17-2021
00:39:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934098
Page 203 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-16-2021
09:59:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-16-2021
09:59:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is d
ue to:
OTHER
If Other, specify:
unknownInitial Entry
Feb-15-2021
21:52:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for "Is
this event related
to study
treatment" is
missing. Kindly
review and
update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934099
Page 204 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021
13:35:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021
13:35:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
RECOVERED/RESOLV
EDNew Information
Feb-18-2021
13:33:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE swollen
lymph node -
right side of neck:
Response to
"What was the
outcome of this
adverse event?" is
'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NO
T RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934100
Page 205 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Feb-12-2021
14:44:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0934101
Page 206 of 228
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-04-2020 08:07:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
Dec/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-04-2020 08:07:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-04-2020 08:07:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Tara Beatty Data Entry:
COMPLETEDInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934102
Page 207 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021 09:48:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
Jan/22/2021Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934103
Page 208 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-22-2021
09:49:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-22-2021
09:49:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Jan-22-2021
09:49:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
Participant is willing to re
turn for Vaccination 3
Participant is:
eligible per other proto
col allowance(s) and c
onfirmed to have recei
ved only placebo at Va
ccination 1/2Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934104
Page 209 of 228
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021 09:49:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
Jan/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021 09:49:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Sperry
RobinsonData Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACCI
NATIONInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934105
Page 210 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 13:30:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
Jan/28/2021Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934106
Page 211 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-28-2021 13:31:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
OBTAINED
Date Written Consent Obt
ained
Jan/28/2021Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934107
Page 212 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-28-2021 13:31:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
Jan/28/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-28-2021 13:31:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-28-2021 13:31:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Dorothy
KurdylaData Entry:
COMPLETEDInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934108
Page 213 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 14:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 14:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 14:10:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 14:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-28-2021 14:10:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi Bays Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934109
Page 214 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Jan-28-2021 14:10:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BP0XHDInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 14:10:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BP0XHDInitial Entry
5.b
Date Location User Value Reason
Jan-28-2021 14:11:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BP0XHFInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-28-2021 14:11:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BP0XHFInitial Entry
5.c
Date Location User Value Reason
Jan-28-2021 14:11:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BPHV6SInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934110
Page 215 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Jan-28-2021 14:11:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BPHV6SInitial Entry
5.d
Date Location User Value Reason
Jan-28-2021 14:11:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BPHV6TInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-28-2021 14:11:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BPHV6TInitial Entry
5.e
Date Location User Value Reason
Jan-28-2021 14:11:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BPHV6VInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-28-2021 14:11:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BPHV6VInitial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934111
Page 216 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 13:43:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 13:43:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 13:43:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 13:43:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-28-2021 13:43:33
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi Bays Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934112
Page 217 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Jan-28-2021 13:43:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
Sample ID: BP0XH2Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-28-2021 13:43:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Kristi
BaysData Entry:
BP0XH2Initial Entry
090177e196ae3d43\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0934113
Page 218 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research
Subject No: 11301081 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-28-2021 15:05:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 D
…[truncated]