Document text
Page 1 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902054
Page 2 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902055
Page 3 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10281033]
2.Birth Date: 1972
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:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902056
Page 4 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902057
Page 5 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902058
Page 6 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902059
Page 7 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Achilles tendon rupture, right]
Start Date: Jun/25/2018
Ongoing: NO
End Date:
Nov/7/2018
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Achilles tendon rupture repair, right]
Start Date: Nov/7/2018
Ongoing: NO
End Date:
Nov/7/2018
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902060
Page 8 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [169.2]
3.Unit: LB
4.Height: [68.5]
5.Unit: in
6.Body Mass Index: [25.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902061
Page 9 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [59313]
3.Randomization Group: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902062
Page 10 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BN61C6]
5.bSample ID [BN61C7]
5.cSample ID [BN61C8]
5.dSample ID [BLBBZH]
5.eSample ID [BLBBZJ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902063
Page 11 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BN61BG]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902064
Page 12 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/20/2020 15:12
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
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902065
Page 13 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902066
Page 14 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902067
Page 15 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902068
Page 16 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BP92JG]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902069
Page 17 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/11/2020 13:04
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
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902070
Page 18 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902071
Page 19 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8ZV7]
5.bSample ID [BR8ZV8]
5.cSample ID [BR8ZV9]
5.dSample ID [BLBCFS]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902072
Page 20 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902073
Page 21 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
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 [BR11H6]
5.bSample ID [BRVT52]
5.cSample ID [BRVT4X]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902074
Page 22 of 155
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902075
Page 23 of 155
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902076
Page 24 of 155
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902077
Page 25 of 155
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902078
Page 26 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902079
Page 27 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902080
Page 28 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902081
Page 29 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902082
Page 30 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902083
Page 31 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902084
Page 32 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902085
Page 33 of 155
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902086
Page 34 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902087
Page 35 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902088
Page 36 of 155
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902089
Page 37 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902090
Page 38 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902091
Page 39 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902092
Page 40 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1. ADVERS
E EVENT
1 elevated body te
mperature Aug/21/2020
UNK:UNK NO
End Date Time:
Aug/22/2020 U
NK:UNK
Repeating
Pages
2. DELETED ADVERS
E EVENT
2 pregnancy of pa
rtner Nov/29/2020
UNK:UNK YES Repeating
Pages
3. ADVERS
E EVENT
3 miscarriage for
pregnant partner
Dec/22/2020
UNK:UNK NO
End Date Time:
Dec/22/2020 U
NK:UNK
Repeating
Pages
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902093
Page 41 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[elevated body temperature]
4.Start Date Time: Aug/21/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/22/2020 UNK:UNK
6.Toxicity Grade: 2
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
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902094
Page 42 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
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[ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902095
Page 43 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[pregnancy of partner ]
4.Start Date Time: Nov/29/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
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
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902096
Page 44 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due
to:
OTHER
If Other, specify:
[pregnancy ]
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?:NOT RECOVERED/NOT 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[ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902097
Page 45 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[miscarriage for pregnant partner]
4.Start Date Time: Dec/22/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/22/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902098
Page 46 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[partner pregnancy]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902099
Page 47 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902100
Page 48 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902101
Page 49 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902102
Page 50 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902103
Page 51 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902104
Page 52 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902105
Page 53 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902106
Page 54 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902107
Page 55 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902108
Page 56 of 155
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902109
Page 57 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902110
Page 58 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902111
Page 59 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902112
Page 60 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902113
Page 61 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902114
Page 62 of 155
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902115
Page 63 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902116
Page 64 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902117
Page 65 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902118
Page 66 of 155
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902119
Page 67 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902120
Page 68 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to return
for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902121
Page 69 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902122
Page 70 of 155
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902123
Page 71 of 155
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902124
Page 72 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/12/2020
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902125
Page 73 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902126
Page 74 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Lillestol Approved Mar-09-2021 13:00:27 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902127
Page 75 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-21-2020 07:59:58 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902128
Page 76 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Dec-21-2020 17:41:27 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902129
Page 77 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Lillestol Approved Mar-09-2021 13:00:27 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Mar-08-2021 15:37:33 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-12-2021 12:18:05 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902130
Page 78 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Feb-12-2021 09:33:23 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-03-2021 12:28:49 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-29-2021 09:09:24 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Jan-21-2021 12:13:45 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902131
Page 79 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Jan-20-2021 08:56:30 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Jan-05-2021 09:59:47 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-21-2020 17:41:15 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Oct-22-2020 17:21:02 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902132
Page 80 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020
07:59:08
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-21-2020
07:59:08
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902133
Page 81 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020
07:59:19
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Aug/20/2020Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902134
Page 82 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-21-2020
07:59:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10281033Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020
07:58:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020
07:59:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020
07:59:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902135
Page 83 of 155
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020
07:59:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902136
Page 84 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020
07:59:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902137
Page 85 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020
08:00:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020
08:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020
08:00:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902138
Page 86 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020
08:00:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:1
Medical
History T
erm:Achilles tend
on rupture, ri
ght
Start Dat
e:Jun/25/2018
Ongoing: NO
End Date:
Nov/7/20
18Changed
Information
Aug-21-2020
08:05:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Achilles ru
pture, right
Start Date
:Jun/25/201
8
Ongoing: NO
End Date:
Nov/7/2
018Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902139
Page 87 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-21-2020
08:05:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
08:00:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Achilles tendon rupture,
rightChanged
Information
Aug-21-2020
08:05:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Achilles rupture, rightInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020
08:05:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jun/25/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020
08:05:42
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/7/2018Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902140
Page 88 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Aug-24-2020
08:00:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:Achilles tendo
n rupture repai
r, right
Start Da
te:Nov/7/2018
Ongoing
:NO
End Date:
Nov/7/201
8Changed
Information
Aug-21-2020
08:06:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Achilles rupt
ure repair, rig
ht
Start Dat
e:Nov/7/2018
Ongoing: NO
End Date:
Nov/7/20
18Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902141
Page 89 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-21-2020
08:06:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-24-2020
08:49:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Aug-24-2020
08:00:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged
Information
Aug-24-2020
08:00:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Achill
es ten
don r
upture
repair,
rightChanged
Information
Aug-22-2020
17:27:33
(UTC-06:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify
ACHILLES
RUPTURE
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0902142
Page 90 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US &
Canada)REPAIR,
RIGHT as
follows...The
term appears
incomplete.
If reporting
ACHILLES
TENDON
RUPTURE
REPAIR,
RIGHT,
update the
verbatim
term as such.
Otherwise
clarify
further and
update the
term as
appropriate.
Thank you.
Aug-21-2020
08:06:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Achill
es rup
ture r
epair,
rightInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-21-2020
08:06:06
(UTC-06:00) Central
Time (US &ACV0PFEINFP6000 Data Entry:
Nov/7/2018Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902143
Page 91 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
1.b Ongoing:
Date Location User Value Reason
Aug-21-2020
08:06:06
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/7/2018Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902144
Page 92 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
169.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &ACV0PFEINFP6000 Data Entry:
68.5Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902145
Page 93 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
5. Unit:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.3Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature: 98.1
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020
08:01:30ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902146
Page 94 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US &
Canada)
7.a Temperature:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020
08:01:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902147
Page 95 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020
08:01:44
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020
08:01:44
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
59313Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902148
Page 96 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020
08:01:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020
08:01:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020
08:04:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-21-2020
08:01:58
(UTC-06:00)
Central 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902149
Page 97 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-21-2020
08:01:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
08:04:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN61C6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020
08:04:07
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN61C6Initial Entry
5.b
Date Location User Value Reason
Aug-21-2020
08:04:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN61C7Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902150
Page 98 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Aug-21-2020
08:04:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN61C7Initial Entry
5.c
Date Location User Value Reason
Aug-21-2020
08:04:32
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN61C8Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020
08:04:32
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN61C8Initial Entry
5.d
Date Location User Value Reason
Aug-21-2020
08:04:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBBZHInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902151
Page 99 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-21-2020
08:04:41
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLBBZHInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020
08:04:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBBZJInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-21-2020
08:04:51
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLBBZJInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902152
Page 100 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020
08:02:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020
08:02:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020
08:03:52
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-21-2020
08:02:06
(UTC-06:00)
Central 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902153
Page 101 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-21-2020
08:02:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020
08:03:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN61BGInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020
08:03:52
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BN61BGInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902154
Page 102 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020 15:12Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902155
Page 103 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902156
Page 104 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-21-2020
08:03:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902157
Page 105 of 155
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-21-2020
08:03:38
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLL
ECTED FOR THIS SUB
JECTInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902158
Page 106 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
18:40:02
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902159
Page 107 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020
18:40:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020
18:40:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Record Identi
fier::1
Temperature: 98.1
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020
18:40:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902160
Page 108 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020
18:40:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-11-2020
18:40:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
18:40:20
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902161
Page 109 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020
18:40:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020
18:40:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020
18:40:40
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
18:40:28
(UTC-06:00)
Central 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902162
Page 110 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020
18:40:28
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
18:40:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP92JGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
18:40:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BP92JGInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902163
Page 111 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/11/2020 13:04Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902164
Page 112 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902165
Page 113 of 155
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020
18:41:01
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902166
Page 114 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020
16:45:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902167
Page 115 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
16:45:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
16:45:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
16:45:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
16:45:34
(UTC-06:00)
Central 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902168
Page 116 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020
16:45:34
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
16:45:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8ZV7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
16:45:50
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BR8ZV7Initial Entry
5.b
Date Location User Value Reason
Oct-12-2020
16:46:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8ZV8Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902169
Page 117 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
16:46:13
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BR8ZV8Initial Entry
5.c
Date Location User Value Reason
Oct-12-2020
16:46:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8ZV9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
16:46:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BR8ZV9Initial Entry
5.d
Date Location User Value Reason
Oct-12-2020
16:46:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBCFSInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902170
Page 118 of 155
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Oct-12-2020
16:46:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BLBCFSInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902171
Page 119 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
15:37:33
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902172
Page 120 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021
15:37:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021
15:37:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021
15:38:02
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
15:37:44
(UTC-06:00)
Central 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.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902173
Page 121 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-08-2021
15:37:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021
15:38:02
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR11H6Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021
15:38:02
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BR11H6Initial Entry
5.b
Date Location User Value Reason
Mar-08-2021
15:38:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVT52Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902174
Page 122 of 155
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Mar-08-2021
15:38:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BRVT52Initial Entry
5.c
Date Location User Value Reason
Mar-08-2021
15:38:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRVT4XInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-08-2021
15:38:26
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
BRVT4XInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902175
Page 123 of 155
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-12-2020
16:49:38
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020
16:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020
16:49:38
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902176
Page 124 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902177
Page 125 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-04-2021
10:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Changed
Information
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902178
Page 126 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-20-2021 08:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902179
Page 127 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
elevated body temperatur
eInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2020 UNK:UNKInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902180
Page 128 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/22/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902181
Page 129 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902182
Page 130 of 155
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020
09:47:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902183
Page 131 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
pregnancy of partnerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Nov/29/2020 UNK:UNKInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902184
Page 132 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US &
Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-21-2020
17:41:27
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-05-2021
07:16:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed event inactivated
in Inform
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902185
Page 133 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-04-2021
10:11:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered Changed data per
query
Dec-31-2020
18:24:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Dec-31-2020
01:30:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued:Ope
nedSAE RECON
1:Per latest listing
event was
invalidated since
it was considered
duplicate with
maternal case
'2020506248' as
partner is also in
this trial. Please
confirm if this
should be
inactivated to
avoid duplication
of report.
Dec-29-2020
12:22:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 5: Answered Changed
Information
Dec-29-2020
12:22:34
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902186
Page 134 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
& Canada)
Dec-29-2020
12:22:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOChanged
Information
Dec-23-2020
09:26:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 5: Opened CLINICAL
Would like to
clarify if the
pregnant partner is
also a study
subject (e.g.
10291003); if so,
only 1 report per
pregnancy is
required. Partner-
in-study
information would
be provided in
female's Exposure
during Pregnancy
report.
Dec-22-2020
11:32:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate For AE pregnancy
of partner:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-22-2020
11:32:16
(UTC-06:00)
Central Time (USACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed
Information
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0902187
Page 135 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
& Canada)
Dec-22-2020
11:32:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-22-2020
11:32:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event a
ssociated with conge
nital anomaly or birth
defect?
NO
Did this serious event
result in death?
NO
Did this serious event
require or prolong ho
spitalization?
NO
Did this serious event
result in persistent or
significant disability/i
ncapacity?
NO
Is this serious event li
fe threatening?Changed
Information
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902188
Page 136 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
NO
Other medically imp
ortant serious event
YES
Dec-22-2020
08:37:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened SAE RECON:
pregnancy of
partner(Onset
date:29Nov2020)
is not reported to
Safety database
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE CRF
Dec-22-2020
07:24:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed
internally
Dec-21-2020
17:41:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes', but
at least one
seriousness
criteria is missing.
Please review and
update as
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902189
Page 137 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
appropriate.
Dec-21-2020
17:41:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE pregnancy
of partner:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Dec-21-2020
17:41:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Other medically imp
ortant serious event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event is
due to:Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902190
Page 138 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
OTHER
If Other, specify:
pregnancy
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902191
Page 139 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Dec-22-2020
11:31:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Dec-22-2020
11:31:58
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NO
T RESOLVEDChanged
Information
Dec-21-2020
17:41:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
pregnancy of
partner:
Response to
"What was the
outcome of this
adverse event?"
is 'Unknown' but
End Date/Time
is provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Dec-21-2020
17:41:15
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902192
Page 140 of 155
***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, Deleted
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-21-2020
17:41:15
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902193
Page 141 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-20-2021 08:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-20-2021 08:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021
12:04:50
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Feb-09-2021
10:00:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered this was already
sent in.
Feb-09-2021
01:22:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Event
term is
'Miscarriage for
PG partner';
however, SAE
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902194
Page 142 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
report
(2020506220)
has event term
'Pregnant
Partner'. Please
submit a SAE
report update
with the SAE
term 'Miscarriage
for PG partner'
Jan-29-2021
11:47:26
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Jan-29-2021
09:09:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Jan-29-2021
09:09:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
miscarriage for pregnan
t partnerChanged
Information
Jan-28-2021
17:23:43
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - As this
reports a SAE
'miscarriage', the
exposure to drug
is not required in
the term (as with
pregnancy,
reported for
10281002), ie
just miscarriage
for pregnant
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902195
Page 143 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
partner.
Jan-20-2021
08:56:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
partner exposure during
pregnancy miscarriageInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-25-2021
08:49:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Safety unit has
confirmed
updates are on
hold as they
resolve technical
reporting
problems
Feb-16-2021
10:40:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered I have a fax
confirmation
that the EDP
was sent on
02Feb2021 and
the SAE follow
up was sent in
on 01Feb2021
Feb-15-2021
22:02:27
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Open
edClinical Thank
you/ however
there has not
been an update
to the SAE
safety report
since the
original report
on 21Dec20
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902196
Page 144 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-09-2021
10:00:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered this was already
sent in.
Feb-09-2021
01:24:47
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - Event
'Miscarriage in
PG partner' start
date is 22Dec20;
however, SAE
report start date
is 29Nov20.
Please review
SAE start date,
harmonize
reporting, and
update in
applicable
location
Jan-20-2021
08:56:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Dec/22/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902197
Page 145 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent
or significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-25-2021
08:50:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Feb-16-2021
02:43:12
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Deleted Query can be
addressed
internally
Feb-09-2021
10:00:07
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 3: Answered confirmed as
entered per
protocol
Feb-09-2021
01:28:34
(UTC-06:00)
Central Time (US &ACV0PFEINFP6000 Query 3: Opened Clinical - Event
serious criterion
is Medically
Important;
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (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-2021-5683-0902198
Page 146 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) however, SAE
report does not
specify any
serious criteria.
Please review
serious criteria,
harmonize
reporting, and
update in the
appropriate
location
Feb-09-2021
01:27:37
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 3: Candidate Clinical - Event
serious criterion
is Medically
Important;
however, SAE
report does not
specify any
serious criteria.
Please review
serious criteria,
harmonize
reporting, and
update in the
appropriate
location
Jan-29-2021
09:09:24
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate For AE
miscarriage for
pregnant
partner:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902199
Page 147 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
blank.
Jan-21-2021
05:02:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed
internally
Jan-20-2021
08:56:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE partner
exposure during
pregnancy
miscarriage:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-20-2021
08:56:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event as
sociated with congenit
al anomaly or birth def
ect?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hosp
italization?Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902200
Page 148 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
NO
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NO
Is this serious event lif
e threatening?
NO
Other medically impor
tant serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event is
due to:Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902201
Page 149 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
OTHER
If Other, specify:
partner pregnancy
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902202
Page 150 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-20-2021
08:56:30
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902203
Page 151 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021
09:35:06
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021Transcription
Error
Feb-12-2021
09:33:23
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902204
Page 152 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021
09:34:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-12-2021
09:33:31
(UTC-06:00)
Central 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.
Feb-12-2021
09:33:31
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to
return for Vaccination 3
Participant is:
eligible and NOT co
nfirmed to have recei
ved only placebo at
Vaccination 1/2Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902205
Page 153 of 155
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021
09:34:57
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021Transcription
Error
Feb-12-2021
09:34:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
09:34:14
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL VA
CCINATIONInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902206
Page 154 of 155
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020
16:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-21-2020
08:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZ
EDInitial Entry
Aug-21-2020
08:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-12-2020
16:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
Aug-21-2020
08:01:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
Aug-21-2020
08:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902207
Page 155 of 155
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281033 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
09:00:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e10\Final\Final On: 01-Apr-2021 04:45 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902208