Document text
Page 1 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901875
Page 2 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901876
Page 3 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10281028]
2.Birth Date: 1987
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:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901877
Page 4 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901878
Page 5 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901879
Page 6 of 179
***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: 10281028 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: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901880
Page 7 of 179
***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: 10281028 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:[Acute non-recurrent pansinusitis]
Start Date: Jan/14/2020
Ongoing: NO
End Date:
Feb/4/2020
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OTITIS MEDIA LEFT]
Start Date: Dec/31/2019
Ongoing: NO
End Date:
Jan/8/2020
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901881
Page 8 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Removed scar tissue REMOVAL, URETHRA]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BICYCLE ACCIDENT]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901882
Page 9 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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: [172.2]
3.Unit: LB
4.Height: [69.5]
5.Unit: in
6.Body Mass Index: [25.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901883
Page 10 of 179
***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: 10281028 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: [58265]
3.Randomization Group: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901884
Page 11 of 179
***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: 10281028 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 [BN61BT]
5.bSample ID [BN61BV]
5.cSample ID [BN61BW]
5.dSample ID [BLBBZ5]
5.eSample ID [BLBBZ6]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901885
Page 12 of 179
***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: 10281028 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 [BN61B9]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901886
Page 13 of 179
***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: 10281028 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 09:45
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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901887
Page 14 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901888
Page 15 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901889
Page 16 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901890
Page 17 of 179
***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: 10281028 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/10/2020
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 [BP92GM]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901891
Page 18 of 179
***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: 10281028 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/10/2020 16:32
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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901892
Page 19 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901893
Page 20 of 179
***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: 10281028 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/8/2020
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 [BP9353]
5.bSample ID [BP9354]
5.cSample ID [BP9355]
5.dSample ID [BLBCF9]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901894
Page 21 of 179
***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: 10281028 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:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901895
Page 22 of 179
***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: 10281028 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: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901896
Page 23 of 179
***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: 10281028 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 [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901897
Page 24 of 179
***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: 10281028 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 [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901898
Page 25 of 179
***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: 10281028 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?
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901899
Page 26 of 179
***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: 10281028 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:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901900
Page 27 of 179
***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: 10281028 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:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901901
Page 28 of 179
***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: 10281028 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 [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901902
Page 29 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901903
Page 30 of 179
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901904
Page 31 of 179
***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: 10281028 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/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901905
Page 32 of 179
***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: 10281028 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: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901906
Page 33 of 179
***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: 10281028 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:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901907
Page 34 of 179
***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: 10281028 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 [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901908
Page 35 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 enlarged lym
ph glands Feb/19/2021
UNK:UNK NO
End Date Time:
Feb/20/2021 UNK
:UNK
Repeating
Pages
2.ADVERSE
EVENT 2 fatigue Feb/19/2021
UNK:UNK NO
End Date Time:
Feb/20/2021 UNK
:UNK
Repeating
Pages
3.ADVERSE
EVENT 3 headache Feb/19/2021
UNK:UNK NO
End Date Time:
Feb/20/2021 UNK
:UNK
Repeating
Pages
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901909
Page 36 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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)[enlarged lymph glands]
4.Start Date Time: Feb/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901910
Page 37 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901911
Page 38 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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[ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901912
Page 39 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[fatigue]
4.Start Date Time: Feb/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901913
Page 40 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901914
Page 41 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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[ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901915
Page 42 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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)[headache]
4.Start Date Time: Feb/19/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901916
Page 43 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901917
Page 44 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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[ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901918
Page 45 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901919
Page 46 of 179
***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: 10281028 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[ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901920
Page 47 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901921
Page 48 of 179
***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: 10281028 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: //
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901922
Page 49 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901923
Page 50 of 179
***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: 10281028 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?
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901924
Page 51 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901925
Page 52 of 179
***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: 10281028 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?
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901926
Page 53 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901927
Page 54 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901928
Page 55 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901929
Page 56 of 179
***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: 10281028 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:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901930
Page 57 of 179
***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: 10281028 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?
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901931
Page 58 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901932
Page 59 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901933
Page 60 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901934
Page 61 of 179
***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: 10281028 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 per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901935
Page 62 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901936
Page 63 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901937
Page 64 of 179
***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: 10281028 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: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901938
Page 65 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901939
Page 66 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/18/2021
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901940
Page 67 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901941
Page 68 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901942
Page 69 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10281028 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:
Feb/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4Z46]
5.bSample ID [BRVT1Z]
5.cSample ID [BRVT1M]
5.dSample ID [BRVT1N]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901943
Page 70 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10281028 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:
Feb/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4Z3W]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901944
Page 71 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 14:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901945
Page 72 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901946
Page 73 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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:
Mar/11/2021
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 [BR11JF]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901947
Page 74 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/11/2021 15:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901948
Page 75 of 179
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901949
Page 76 of 179
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901950
Page 77 of 179
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901951
Page 78 of 179
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901952
Page 79 of 179
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901953
Page 80 of 179
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901954
Page 81 of 179
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901955
Page 82 of 179
***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: 10281028 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/8/2020
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901956
Page 83 of 179
***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: 10281028 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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901957
Page 84 of 179
***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: 10281028 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-12-2021 13:06:46 (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.
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901958
Page 85 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-20-2020 16:16:31 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901959
Page 86 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-18-2021 15:45:45 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901960
Page 87 of 179
***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: 10281028 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-12-2021 13:06:46 (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-11-2021 16:28:26 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-23-2021 13:06:49 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901961
Page 88 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 Feb-18-2021 15:45:27 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-12-2021 12:16:16 (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.
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901962
Page 89 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Feb-12-2021 09:41:00 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Oct-22-2020 17:18:58 (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.
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901963
Page 90 of 179
***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: 10281028 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-20-2020
16:15:52
(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-20-2020
16:15:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901964
Page 91 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020
16:16:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/20/2020Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901965
Page 92 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020
16:15:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10281028Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020
16:15:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1987Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020
16:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901966
Page 93 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020
16:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020
16:16:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901967
Page 94 of 179
***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: 10281028 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-20-2020
16:16:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901968
Page 95 of 179
***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: 10281028 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-20-2020
16:16:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020
16:16:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020
16:16:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901969
Page 96 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020
16:20:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:Acute non-re
current pansi
nusitis
Start Da
te:Jan/14/2020
Ongoing
:NO
End Date:
Feb/4/202
0Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:20:09
(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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901970
Page 97 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020
16:20:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Acute non-recurrent
pansinusitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-20-2020
16:20:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020
16:20:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/4/2020Initial Entry
1.b
Date Location User Value Reason
Aug-20-2020
16:20:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901971
Page 98 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical
History T
erm:OTITIS M
EDIA LEF
T
Start Dat
e:Dec/31/201
9
Ongoing: NO
End Date:
Jan/8/20
20
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901972
Page 99 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:20:37
(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 Value Reason
Aug-20-2020
16:20:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTITIS MEDIA LE
FTInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-20-2020
16:20:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/31/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-20-2020
16:20:37ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901973
Page 100 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Jan/8/2020
1.c
Date Location User Value Reason
Aug-20-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:3
Medic
al Hist
ory Te
rm:Removed scar
tissue REMO
VAL, URETH
RA
Start
Date:UNK/UNK/20
08
Ongoi
ng:NO
End Date:
UNK/UNK
/2008Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901974
Page 101 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Removed scar tissue
REMOVAL, URET
HRAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-20-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-20-2020
16:21:06ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901975
Page 102 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2008
1.d
Date Location User Value Reason
Aug-20-2020
16:21:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:BICYCLE
ACCIDEN
T
Start Dat
e:UNK/UNK
/2003
Ongoing: NO
End Date:
UNK/U
NK/200
3Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0901976
Page 103 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:21:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020
16:21:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000
)Data Entry:
BICYCLE ACCIDE
NTInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-20-2020
16:21:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-20-2020
16:21:28ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901977
Page 104 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
UNK/UNK/2003
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0901978
Page 105 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
172.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901979
Page 106 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
69.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.1Initial Entry
7.a
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperatu
re:98.0Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901980
Page 107 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901981
Page 108 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020
16:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901982
Page 109 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020
16:17:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020
16:17:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
58265Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901983
Page 110 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020
16:17:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
16:17:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020
16:18:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-20-2020
16:17:47
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901984
Page 111 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-20-2020
16:17:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
16:18:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN61B
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020
16:18:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61BTInitial Entry
5.b
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901985
Page 112 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020
16:18:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN61B
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020
16:18:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61BVInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020
16:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN61B
WInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901986
Page 113 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-20-2020
16:18:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61BWInitial Entry
5.d
Date Location User Value Reason
Aug-20-2020
16:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLBBZ
5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-20-2020
16:18:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLBBZ5Initial Entry
5.e
Date Location User Value Reason
Aug-20-2020
16:19:06ACV0PFEINFP6000 Data Entry:
Sample I BLBBZInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901987
Page 114 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)D: 6
5.e Sample ID
Date Location User Value Reason
Aug-20-2020
16:19:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLBBZ6Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901988
Page 115 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020
16:19:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
16:19:16
(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-20-2020
16:19:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-20-2020
16:19:16
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901989
Page 116 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-20-2020
16:19:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
16:19:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN61B
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020
16:19:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN61B9Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901990
Page 117 of 179
***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: 10281028 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-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901991
Page 118 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020 09:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020
16:19:38
(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-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901992
Page 119 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-20-2020
16:19:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901993
Page 120 of 179
***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: 10281028 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-20-2020
16:19:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0901994
Page 121 of 179
***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: 10281028 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
14:14:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0901995
Page 122 of 179
***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: 10281028 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
14:14:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020
14:14:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:99.2
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020
14:14:38
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0901996
Page 123 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-11-2020
14:14:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
99.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-11-2020
14:14:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020
14:14:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0901997
Page 124 of 179
***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: 10281028 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
14:14:54
(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
14:14:54
(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
14:15:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-11-2020
14:14:54
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0901998
Page 125 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-11-2020
14:14:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020
14:15:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP92G
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020
14:15:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP92GMInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0901999
Page 126 of 179
***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: 10281028 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
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020
14:15:25
(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
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902000
Page 127 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020 16:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020
14:15:25
(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
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902001
Page 128 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-11-2020
14:15:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0902002
Page 129 of 179
***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: 10281028 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-08-2020
16:19:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902003
Page 130 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
16:19:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
16:19:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020
17:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-08-2020
16:19:28
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902004
Page 131 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-08-2020
16:19:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020
17:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP935
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020
17:05:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9353Initial Entry
5.b
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902005
Page 132 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-08-2020
17:05:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP935
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020
17:05:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9354Initial Entry
5.c
Date Location User Value Reason
Oct-08-2020
17:05:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP935
5Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902006
Page 133 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Oct-08-2020
17:05:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9355Initial Entry
5.d
Date Location User Value Reason
Oct-08-2020
17:05:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLBCF
9Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-08-2020
17:05:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLBCF9Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902007
Page 134 of 179
***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: 10281028 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-08-2020
16:19:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020
16:19:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020
16:19:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902008
Page 135 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902009
Page 136 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902010
Page 137 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902011
Page 138 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
08:33:43
(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
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
enlarged lymph glan
dsInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902012
Page 139 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/20/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
08:33:43
(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).
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902013
Page 140 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
08:33:43
(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.
Date Location User Value Reason
Mar-12-2021
08:33:43
(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
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021
08:33:43
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902014
Page 141 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021
08:33:43
(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
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902015
Page 142 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
08:33:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902016
Page 143 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
08:34:09
(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
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
fatigueInitial Entry
4. Start Date Time:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902017
Page 144 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/20/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
08:34:09
(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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902018
Page 145 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-12-2021
08:34:09
(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.
Date Location User Value Reason
Mar-12-2021
08:34:09
(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
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902019
Page 146 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021
08:34:09
(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
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902020
Page 147 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021
08:34:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902021
Page 148 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021
08:35:25
(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
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
headacheInitial Entry
4. Start Date Time:
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902022
Page 149 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/20/2021 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021
08:35:25
(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
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902023
Page 150 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-12-2021
08:35:25
(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.
Date Location User Value Reason
Mar-12-2021
08:35:25
(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
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902024
Page 151 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021
08:35:25
(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
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902025
Page 152 of 179
***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
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021
08:35:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902026
Page 153 of 179
***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: 10281028 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
09:41:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902027
Page 154 of 179
***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: 10281028 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
09:41:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-12-2021
09:41:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-12-2021
09:41:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loca
l/national reco
mmendations a
nd confirmed toInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902028
Page 155 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
have received o
nly placebo at V
accination 1/2
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902029
Page 156 of 179
***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: 10281028 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
09:41:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-12-2021
09:41:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902030
Page 157 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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-18-2021
15:45:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902031
Page 158 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-18-2021
15:45:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Feb/18/2021Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0902032
Page 159 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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
Feb-18-2021
15:45:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-18-2021
15:45:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-18-2021
15:45:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902033
Page 160 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
15:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
15:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
15:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
15:47:49
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902034
Page 161 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-18-2021
15:47:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
15:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BR4Z4
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
15:48:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR4Z46Initial Entry
5.b
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902035
Page 162 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-18-2021
15:48:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVT1
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-18-2021
15:48:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVT1ZInitial Entry
5.c
Date Location User Value Reason
Feb-18-2021
15:48:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVT1
MInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0902036
Page 163 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Feb-18-2021
15:48:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVT1MInitial Entry
5.d
Date Location User Value Reason
Feb-18-2021
15:48:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRVT1
NInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-18-2021
15:48:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRVT1NInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902037
Page 164 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
15:48:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
15:48:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
15:49:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
15:48:53
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902038
Page 165 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-18-2021
15:48:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
15:49:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR4Z3
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
15:49:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR4Z3WInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902039
Page 166 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0902040
Page 167 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/18/2021 14:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902041
Page 168 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021
15:50:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-18-2021
15:50:05ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902042
Page 169 of 179
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902043
Page 170 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 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-11-2021
16:28:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/11/2021Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902044
Page 171 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-11-2021
16:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021
16:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021
16:29:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-11-2021
16:28:50
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902045
Page 172 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-11-2021
16:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021
16:29:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BR11J
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021
16:29:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR11JFInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902046
Page 173 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902047
Page 174 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/11/2021 15:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902048
Page 175 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-11-2021
16:29:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Mar-11-2021
16:29:58ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902049
Page 176 of 179
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902050
Page 177 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-08-2020
16:19:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020
16:17:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-20-2020
16:16:40
(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-08-2020
16:19:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/8/2020Initial Entry
Aug-20-2020
16:17:35ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902051
Page 178 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Aug-20-2020
16:16:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902052
Page 179 of 179
***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: 10281028 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
09:11:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e05\Final\Final On: 01-Apr-2021 04:43 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0902053