Document text
Page 1 of 137
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version06 OCT 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788507
Page 2 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/19/2020
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788508
Page 3 of 137
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10661350]
2.Birth Date: /1962
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:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788509
Page 4 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788510
Page 5 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788511
Page 6 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788512
Page 7 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyponatremia]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788513
Page 8 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[history of seizure]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spinal stenosis]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[history of alcohol abuse]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788514
Page 9 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[L4-L5 laminotomy with diskectomy]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[morphine allergy]
Start Date: UNK/UNK/1985
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sulfa allergy]
Start Date: UNK/UNK/1980
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cardiomyopathy]
Start Date: Mar/UNK/2018
Ongoing: YES
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788515
Page 10 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[myocardial infarction]
Start Date: Mar/UNK/2018
Ongoing: NO
End Date:
Mar/UNK/2018
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788516
Page 11 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788517
Page 12 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [185.3]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [25.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788518
Page 13 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [270819]
3.Randomization Group: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788519
Page 14 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6T8S]
5.bSample ID [BS5DV6]
5.cSample ID [BS5DV7]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788520
Page 15 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6T7X]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788521
Page 16 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/19/2020 13:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788522
Page 17 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788523
Page 18 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788524
Page 19 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788525
Page 20 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788526
Page 21 of 137
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788527
Page 22 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788528
Page 23 of 137
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788529
Page 24 of 137
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788530
Page 25 of 137
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788531
Page 26 of 137
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788532
Page 27 of 137
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788533
Page 28 of 137
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788534
Page 29 of 137
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788535
Page 30 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788536
Page 31 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788537
Page 32 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788538
Page 33 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788539
Page 34 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788540
Page 35 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788541
Page 36 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788542
Page 37 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788543
Page 38 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788544
Page 39 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788545
Page 40 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 myocardial infa
rction Nov/3/2020 UNK
:UNK NO
End Date Time:
Nov/3/2020 UNK:UNK
Repeating
Pages
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788546
Page 41 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[myocardial infarction]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/3/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788547
Page 42 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[disease progression]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020446214]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788548
Page 43 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1. Repeating
Pages
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788549
Page 44 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788550
Page 45 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788551
Page 46 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788552
Page 47 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788553
Page 48 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788554
Page 49 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788555
Page 50 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788556
Page 51 of 137
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788557
Page 52 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788558
Page 53 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788559
Page 54 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788560
Page 55 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788561
Page 56 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788562
Page 57 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788563
Page 58 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788564
Page 59 of 137
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788565
Page 60 of 137
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788566
Page 61 of 137
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788567
Page 62 of 137
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788568
Page 63 of 137
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788569
Page 64 of 137
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788570
Page 65 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Applicable
//Comments
2.Erroneous Visit Not Applicable Comments
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788571
Page 66 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788572
Page 67 of 137
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788573
Page 68 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788574
Page 69 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788575
Page 70 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification
of Death:Nov/10/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [myocardial infarction]
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788576
Page 71 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/3/2020
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788577
Page 72 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788578
Page 73 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788579
Page 74 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-19-2020 15:43:38 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788580
Page 75 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-09-2021 08:24:44 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788581
Page 76 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-09-2021 08:24:44 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788582
Page 77 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Mar-09-2021 08:24:44 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788583
Page 78 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-09-2021 08:25:02 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788584
Page 79 of 137
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-09-2021 08:25:02 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788585
Page 80 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-09-2021 08:24:44 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David Butuk Approved Jan-26-2021 20:36:38 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidButuk, 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.
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788586
Page 81 of 137
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020 15:42:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020 15:42:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788587
Page 82 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020 15:43:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Oct/19/2020Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788588
Page 83 of 137
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020 15:42:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10661350Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020 15:42:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1962Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020 15:43:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-19-2020 15:43:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020 15:43:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788589
Page 84 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 15:43:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788590
Page 85 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020 15:43:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 15:43:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 15:43:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788591
Page 86 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020 15:44:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:GERD
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:44:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:44:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-19-2020 15:44:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788592
Page 87 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:44:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-19-2020 15:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:anxiety
Start Date: UNK/UNK/
1990
Ongoing: YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788593
Page 88 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
anxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020 15:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-19-2020 15:44:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-19-2020 15:44:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:hypertension
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788594
Page 89 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:44:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:44:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020 15:44:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-19-2020 15:44:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-19-2020 15:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:hyponatremi
a
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788595
Page 90 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hyponatremiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020 15:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-19-2020 15:44:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-19-2020 15:45:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:insomnia
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788596
Page 91 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:45:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:45:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-19-2020 15:45:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-19-2020 15:45:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-19-2020 15:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:history of seiz
ure
Start Date: UNK/UNK/20
15Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788597
Page 92 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
UNK/UNK
/2015
1.f Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
history of seizureInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-19-2020 15:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-19-2020 15:45:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.g
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788598
Page 93 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:spinal stenosis
Start Date: UNK/UNK/20
12
Ongoing: NO
End Date:
UNK/UNK
/2012Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788599
Page 94 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
spinal stenosisInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-19-2020 15:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-19-2020 15:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.h
Date Location User Value Reason
Oct-19-2020 15:45:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:history of alcoh
ol abuse
Start Date: UNK/UNK/201
8Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788600
Page 95 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
UNK/UNK/
2018
1.h Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:45:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:45:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
history of alcohol abuseInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-19-2020 15:45:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-19-2020 15:45:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.i
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788601
Page 96 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical Hi
story Term
:L4-L5 laminotomy
with diskectomy
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/201
2Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788602
Page 97 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.i Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
L4-L5 laminotomy with diske
ctomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-19-2020 15:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-19-2020 15:46:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.j
Date Location User Value Reason
Oct-19-2020 15:47:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:morphine all
ergy
Start Date: UNK/UNK/
1985Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788603
Page 98 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:47:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:47:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
morphine allergyInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-19-2020 15:47:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-19-2020 15:47:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788604
Page 99 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.k
Date Location User Value Reason
Oct-19-2020 15:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:sulfa allergy
Start Date: UNK/UNK/
1980
Ongoing: YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788605
Page 100 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.k Line/MH Number:
Date Location User Value Reason
Oct-19-2020 15:47:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 15:47:13
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
sulfa allergyInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-19-2020 15:47:13
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.k Ongoing:
Date Location User Value Reason
Nov-12-2020 12:59:15
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Nov-12-2020 12:52:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-11-2020 21:55:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
MH update to be
completed for
cardiovascular
history in line with
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788606
Page 101 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
AE of MI
Nov-11-2020 16:39:41
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Candidate CLINQUERY:
MH update to be
completed for
cardiovascular
history in line with
AE of MI
Oct-19-2020 15:47:13
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Nov-12-2020 12:51:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History
Term:cardiomyop
athy
Start Date: Mar/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788607
Page 102 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.l Line/MH Number:
Date Location User Value Reason
Nov-12-2020 12:51:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020 12:51:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cardiomyopathyInitial Entry
1.l Start Date:
Date Location User Value Reason
Nov-12-2020 12:51:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2018Initial Entry
1.l Ongoing:
Date Location User Value Reason
Nov-12-2020 12:51:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Nov-12-2020 12:52:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histo
ry Term:myocardial inf
arction
Start Date: Mar/UNK/201
8Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788608
Page 103 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
Mar/UNK/
2018
1.m Line/MH Number:
Date Location User Value Reason
Nov-12-2020 12:52:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020 12:52:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
myocardial infarctionInitial Entry
1.m Start Date:
Date Location User Value Reason
Nov-12-2020 12:52:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Nov-12-2020 12:52:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/UNK/2018Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788609
Page 104 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-19-2020 15:47:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788610
Page 105 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
185.3Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788611
Page 106 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.1Initial Entry
7.a
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifi
er::1
Temperature: 98.8
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788612
Page 107 of 137
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:47:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788613
Page 108 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020 15:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020 15:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
270819Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788614
Page 109 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 15:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 15:48:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 15:50:12
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 15:48:21
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-19-2020 15:48:21
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788615
Page 110 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR6T8SInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 15:50:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR6T8SInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020 17:50:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS5DV6Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 17:50:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS5DV6Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020 17:50:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS5DV7Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 17:50:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS5DV7Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788616
Page 111 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 15:48:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 15:48:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 15:49:53
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 15:48:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-19-2020 15:48:32
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788617
Page 112 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:49:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR6T7XInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 15:49:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR6T7XInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788618
Page 113 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/19/2020 13:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788619
Page 114 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-19-2020 15:49:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788620
Page 115 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-19-2020 15:49:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788621
Page 116 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788622
Page 117 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Mar-08-2021
14:45:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedQuery closed;
will follow for
requested
clinical course
information.
Mar-08-2021
12:14:13
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dFU re-faxed
Mar-05-2021
20:28:00
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Open
edClinical -
Followup: no
SAE update
yet; please
submit the
information
(no death cert
received;
spouse
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788623
Page 118 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
reported the
cause of death
to site) as a
SAE Safety
update
Feb-24-2021
14:29:15
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dSAE safety
updated will
be submitted
to Pfizer
safety with
this
information
Feb-22-2021
20:47:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Rei
ssued:
Open
edCLINICAL
Thank you;
please submit
this
information
(no death cert
received;
spouse
reported the
cause of death
to site) as a
SAE Safety
update
Feb-20-2021
11:51:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dreported by
subject
spouse. death
certificate not
provided to
site
Feb-19-2021
00:29:00
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedClinical -
Please clarify
in SAE safety
update who
specified
cause of death
(for death at
home), ie
primary MD
or Med
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0788624
Page 119 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Examiner.
Please
confirm cause
of death on
Death
certificate.
Feb-18-2021
10:15:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ca
ndidat
eClinical -
Please clarify
in SAE safety
update who
specified
cause of death
(for death at
home), ie
primary MD
or Med
Examiner.
Please
confirm cause
of death on
Death
certificate.
Nov-15-2020
07:42:08
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedthe MI
reported in
Med hx is a
prior MI;
occurred in
2018
Nov-14-2020
09:26:57
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedThe AE
myocardial
infarction was
reported but is
also listed in
Medical
History.
Please clarify
if this is a
worsening of
the baseline
condition, and
if so, please
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788625
Page 120 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
consider
adding
"worsening"
to the AE
term. AE as
baseline
conditions
should only
be reported as
AEs if they
worsen.
Nov-10-2020
13:41:02
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
myoc
ardial
infarc
tionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/3/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788626
Page 121 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-12-2020 11:15:14
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 13:41:45
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-10-2020 13:41:45
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event resul
t in death?
YES
Did this serious event requi
re or prolong hospitalizatio
n?
NO
Did this serious event resulTranscription
Error
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788627
Page 122 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NO
Nov-10-2020 13:41:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes', but
at least one
seriousness criteria
is missing. Please
review and update
as appropriate.
Nov-10-2020 13:41:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
myocardial
infarction:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-10-2020 13:41:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YES
Did this serious event resul
t in death?
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788628
Page 123 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020
12:59:02 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Nov-12-2020
12:53:04 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Nov-12-2020
03:41:43 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Reissued:Opened CLINQUERY: to
confirm, the MH
page is now
unfrozen and can
be updated
Nov-11-2020
19:29:51 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020
16:37:41 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 2: Answered please unfreeze
MH form to update
data
Nov-11-2020
16:36:15 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Opened CLINQUERY:
Please review the
MH entries for this
subject and clarify
if updates are
needed to capture
the prior
cardiovascular
history. Page can be
unlocked if updates
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788629
Page 124 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
needed
Nov-11-2020
15:31:32 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-11-2020
15:31:32 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:
disease progressionChanged
Information
Nov-11-2020
14:14:29 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL - Event
relationship is
reported as
UNKNOWN;
however, SAE
report states it was
due to 'progression
of underlying
disease' in this
subject with Past
Med H of MI &
cardiomyopathy.
Please review, and
update as
appropriate.
Nov-10-2020
13:43:21 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study tre
atment(s), this event is due
to:
OTHER
If Other, specify:Transcription Error
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788630
Page 125 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
uknown
Nov-10-2020
13:41:02 (UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
08:28:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Acceptable discrepancy per
Clinical review
Nov-14-2020
08:26:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:Can
didatepending Clinical review
Nov-13-2020
06:48:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered changed data per query.
"CLINQUERY: Please
review this entry - since
event was fatal prior to V2
the status for this question
can also be reported as
Drug Withdrawn to link to
the EOT page"
Nov-13-2020
01:37:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020446214
,action taken was reported
as DRUG WITHDRAWN
in AE CRF while NOT
APPLICABLE in Safety
database.Please confirm. If
safety update is required,
please submit a follow up
form
Nov-11-2020
16:36:41ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies query
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788631
Page 126 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-07:00)
Mountain Time (US
& Canada)
Nov-11-2020
16:35:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Nov-11-2020
16:35:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHDRAW
NChanged Information
Nov-11-2020
16:32:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY: Please
review this entry - since
event was fatal prior to V2
the status for this question
can also be reported as
Drug Withdrawn to link to
the EOT page
Nov-10-2020
13:41:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-10-2020 13:41:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0788632
Page 127 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020 19:29:00
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 15:35:57
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-11-2020 15:31:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to
"What was the
outcome of this
adverse event?" is
'Fatal' but Date of
Collection /
Notification of
Death on the
Death Details
form is not
completed. Please
review and update
as appropriate.
Nov-11-2020 15:31:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Nov-11-2020 15:31:47
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FATALTranscription
Error
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788633
Page 128 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020 14:12:33
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL AE
report for this
Event of MI states
'Recovered';
however, SAE
report states this
was a fatal event.
Please review, and
update as
appropriate
Nov-10-2020 13:41:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 16:33:24
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed fatal event,
disposition pages
completed.
Nov-11-2020 15:37:36
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-11-2020 10:23:49
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Event is reported
to have led to end
of study, but not
end of treatment.
Please review this
entry and the
question 'Last
action taken with
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788634
Page 129 of 137
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
study Rx' and
confirm for
EOT/FUP status
updates
Nov-10-2020 13:41:02
(UTC-07:00)
Mountain Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-12-2020 11:15:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020446214Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788635
Page 130 of 137
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020 15:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020 15:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020 15:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788636
Page 131 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 08:24:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-09-2021 08:24:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788637
Page 132 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-09-2021 08:25:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788638
Page 133 of 137
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020 15:37:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020 15:37:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020 15:37:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788639
Page 134 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Nov-11-2020
23:17:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed As per site confirmation on
date of notification
Nov-11-2020
16:16:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered site was not notified of
death until 10-NOV-2020
Nov-11-2020
15:37:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 03/Nov/2020. Please
review and update as
appropriate
Nov-11-2020
15:35:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2.a
Date Location User Value Reason
Nov-11-2020 15:36:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of D
eath Status
:PRIMARY CA
USE OF DEAT
H
Cause of D
eath:myocardial infa
rctionInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788640
Page 135 of 137
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Cause of Death Status:
Date Location User Value Reason
Nov-11-2020 15:36:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CAUSE OF DEA
THInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Nov-11-2020 15:36:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
myocardial infarctionInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788641
Page 136 of 137
***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: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020 15:37:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-11-2020 15:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-19-2020 15:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-19-2020 15:43:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 15:37:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/3/2020Initial Entry
Nov-11-2020 15:36:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/3/2020Initial Entry
Oct-19-2020 15:48:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Oct-19-2020 15:43:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788642
Page 137 of 137
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1066 Site Name: (1066) Solaris Clinical Research
Subject No: 10661350 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020 07:50:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30eb\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788643