Document text
Page 1 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915406
Page 2 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915407
Page 3 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [10541067]
2.Birth Date: /1984
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0915408
Page 4 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915409
Page 5 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915410
Page 6 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915411
Page 7 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gallstones]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholecystectomy]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[environmental allergies]
Start Date: UNK/UNK/2014
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety (intermittent)]
Start Date: UNK/UNK/2001
Ongoing: YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915412
Page 8 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[salpingectomy, bilateral]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/2010
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[scar in abdomen]
Start Date: UNK/UNK/2018
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TMJ dysfunction]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915413
Page 9 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [77.0]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [30.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915414
Page 10 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915415
Page 11 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [71999]
3.Randomization Group: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915416
Page 12 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPYWS8]
5.bSample ID [BPYWS9]
5.cSample ID [BPYWSB]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915417
Page 13 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPYWSC]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915418
Page 14 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 09:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915419
Page 15 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915420
Page 16 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915421
Page 17 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915422
Page 18 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915423
Page 19 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BM98TP]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915424
Page 20 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 08:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915425
Page 21 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915426
Page 22 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYX50]
5.bSample ID [BPYX51]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915427
Page 23 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915428
Page 24 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915429
Page 25 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915430
Page 26 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915431
Page 27 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915432
Page 28 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915433
Page 29 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915434
Page 30 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915435
Page 31 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915436
Page 32 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915437
Page 33 of 192
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915438
Page 34 of 192
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915439
Page 35 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915440
Page 36 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915441
Page 37 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Headache Aug/28/2020 17:3
0 NO
End Date Time:
Aug/29/2020 15:00
Repeating
Pages
2.ADVERSE E
VENT 2 vertigo Sep/20/2020 UN
K:UNK NO
End Date Time:
Sep/22/2020 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 fluid R ear Sep/22/2020 UN
K:UNK NO
End Date Time:
Feb/13/2021 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 decreased hearing R e
ar Sep/20/2020 UN
K:UNK YES Repeating
Pages
5.ADVERSE E
VENT 5 Tinnitus R ear Sep/20/2020 UN
K:UNK YES Repeating
Pages
6.ADVERSE E
VENT 6 headache Sep/18/2020 18:0
0 NO
End Date Time:
Sep/19/2020 10:00
Repeating
Pages
7.ADVERSE E
VENT 7 worsening R TMJ dys
function Feb/12/2021 UN
K:UNK YES Repeating
Pages
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915442
Page 38 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[Headache]
4.Start Date Time: Aug/28/2020 17:30
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/29/2020 15:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915443
Page 39 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915444
Page 40 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[vertigo]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/22/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown, possible allergy]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915445
Page 41 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915446
Page 42 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fluid R ear]
4.Start Date Time: Sep/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/13/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown, possible allergy]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915447
Page 43 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915448
Page 44 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[decreased hearing R ear]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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:
[unknown, possible allergy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915449
Page 45 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915450
Page 46 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Tinnitus R ear]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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:
[unknown, possible allergy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915451
Page 47 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915452
Page 48 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache]
4.Start Date Time: Sep/18/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/19/2020 10:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915453
Page 49 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915454
Page 50 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsening R TMJ dysfunction]
4.Start Date Time: Feb/12/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[TMJ 2/2 increased stress, has a h/o TMJ dysfunction]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915455
Page 51 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915456
Page 52 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915457
Page 53 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915458
Page 54 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915459
Page 55 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915460
Page 56 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915461
Page 57 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915462
Page 58 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915463
Page 59 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915464
Page 60 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915465
Page 61 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915466
Page 62 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915467
Page 63 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915468
Page 64 of 192
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915469
Page 65 of 192
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915470
Page 66 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915471
Page 67 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915472
Page 68 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915473
Page 69 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915474
Page 70 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915475
Page 71 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915476
Page 72 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915477
Page 73 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915478
Page 74 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/3/2021
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915479
Page 75 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915480
Page 76 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/3/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915481
Page 77 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/3/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915482
Page 78 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR54YF]
5.bSample ID [BR54YG]
5.cSample ID [BR54YH]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915483
Page 79 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR54YJ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915484
Page 80 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915485
Page 81 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915486
Page 82 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/26/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915487
Page 83 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMTLT]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915488
Page 84 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 08:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915489
Page 85 of 192
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915490
Page 86 of 192
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915491
Page 87 of 192
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915492
Page 88 of 192
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915493
Page 89 of 192
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915494
Page 90 of 192
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915495
Page 91 of 192
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915496
Page 92 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/16/2020
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915497
Page 93 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915498
Page 94 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915499
Page 95 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormAug-28-2020 10:27:07 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915500
Page 96 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormFeb-04-2021 09:34:03 (UTC-08:00) Pacific
Time (US & Canada)Steven Choi Not Applicable
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915501
Page 97 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
Steven Choi N/A Feb-04-2021 09:30:31 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Oct-21-2020 09:12:22 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkLeibowitz, 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.
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915502
Page 98 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 10:24:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 10:24:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
STAGE 3 COHORTSInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915503
Page 99 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 10:25:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915504
Page 100 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 10:24:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10541067Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 10:24:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1984Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 10:25:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 10:25:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 10:25:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
WHITEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915505
Page 101 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 10:26:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915506
Page 102 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 10:27:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 10:27:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 10:27:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915507
Page 103 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 10:29:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:gallstones
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:29:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:29:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
gallstonesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 10:29:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915508
Page 104 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-28-2020 10:29:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.b
Date Location User Value Reason
Aug-28-2020 10:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:cholecystectom
y
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915509
Page 105 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
cholecystectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 10:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 10:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.c
Date Location User Value Reason
Aug-28-2020 10:31:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:environmental a
llergies
Start Date: UNK/UNK/201
4
Ongoing: YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915510
Page 106 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:31:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:31:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
environmental allergiesInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 10:31:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 10:31:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-28-2020 10:32:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:anxiety (interm
ittent)
Start Date: UNK/UNK/20
01
Ongoing: YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915511
Page 107 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:32:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:32:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
anxiety (intermittent)Initial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 10:32:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2001Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 10:32:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-28-2020 10:32:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:salpingectomy, b
ilateral
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915512
Page 108 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:32:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:32:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
salpingectomy, bilateralInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 10:32:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 10:32:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.f
Date Location User Value Reason
Aug-28-2020 10:33:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:asthma
Start Date: UNK/UNK/199
8Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915513
Page 109 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Ongoing: NO
End Date:
UNK/UNK/
2010
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:33:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:33:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
asthmaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 10:33:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/1998Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 10:33:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.g
Date Location User Value Reason
Aug-28-2020 10:33:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915514
Page 110 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Medical History T
erm:scar in abdom
en
Start Date: UNK/UNK/2
018
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020 10:33:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 10:33:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
scar in abdomenInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020 10:33:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020 10:33:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-16-2020 11:18:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:TMJ dysfunct
ionInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915515
Page 111 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Start Date: UNK/UNK/2
018
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Oct-16-2020 11:18:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 11:18:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
TMJ dysfunctionInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-16-2020 11:18:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-16-2020 11:18:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915516
Page 112 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
77.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
159.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) PacificACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.5Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915517
Page 113 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 10:35:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915518
Page 114 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915519
Page 115 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 10:35:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NEGATIVEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915520
Page 116 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 10:35:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 10:35:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
71999Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915521
Page 117 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 10:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 10:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 18:46:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 10:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 10:36:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 18:46:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BPYWS8Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915522
Page 118 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 18:46:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BPYWS8Initial Entry
5.b
Date Location User Value Reason
Aug-28-2020 18:46:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BPYWS9Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 18:46:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BPYWS9Initial Entry
5.c
Date Location User Value Reason
Aug-28-2020 18:47:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BPYWSBInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 18:47:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BPYWSBInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915523
Page 119 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 10:36:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 10:36:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 18:47:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 10:36:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 10:36:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 18:47:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BPYWSCInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915524
Page 120 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 18:47:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BPYWSCInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915525
Page 121 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020 09:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) PacificACV0PFEINFP6000 Steven
ChoiData Entry:
RIGHTInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915526
Page 122 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 10:36:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915527
Page 123 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 10:36:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915528
Page 124 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 09:16:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/18/2020Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915529
Page 125 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 09:17:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 09:17:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Record Identifier:
:1
Temperature: 98.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 09:17:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 09:17:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 09:17:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
FInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915530
Page 126 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 09:17:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915531
Page 127 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915532
Page 128 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 09:17:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NEGATIVEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915533
Page 129 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 09:17:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 09:17:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 09:29:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 09:17:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-18-2020 09:17:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 09:29:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BM98TPInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915534
Page 130 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 09:29:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BM98TPInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915535
Page 131 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-21-2020 08:26:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/18/2020 08:33Transcription Error
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/18/2020 08:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915536
Page 132 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 09:18:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915537
Page 133 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 10:13:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Oct/16/2020Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915538
Page 134 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 10:13:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 10:13:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 14:04:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 10:13:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 10:13:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 14:04:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BPYX50Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915539
Page 135 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 14:04:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BPYX50Initial Entry
5.b
Date Location User Value Reason
Oct-16-2020 14:04:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BPYX51Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 14:04:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BPYX51Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915540
Page 136 of 192
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020 10:15:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 10:15:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 10:15:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915541
Page 137 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915542
Page 138 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915543
Page 139 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915544
Page 140 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915545
Page 141 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915546
Page 142 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915547
Page 143 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915548
Page 144 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Aug/28/2020 17:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO
End Date Time:
Aug/29/2020 15:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915549
Page 145 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-03-2020 12:45:52 ACV0PFEINFP6000 Steven Data Entry: Transcription Error
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915550
Page 146 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-08:00) Pacific
Time (US & Canada)Choi YES
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-03-2020 11:02:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915551
Page 147 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
vertigoInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NO
End Date Time:
Sep/22/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915552
Page 148 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown, possible allergyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) PacificACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915553
Page 149 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 10:18:01
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915554
Page 150 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
fluid R earInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/22/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 01:34:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-04-2021 11:49:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Mar-04-2021 11:49:56 ACV0PFEINFP6000 Steven Choi Data Entry: Changed
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915555
Page 151 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-08:00) Pacific
Time (US & Canada)NO
End Date Time:
Feb/13/2021 UNK:UNKInformation
Mar-03-2021 10:03:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPD CLINQUERY:
Please confirm if
AE is ongoing and
without change to
severity.
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven Choi Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915556
Page 152 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown, possible allergyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 11:55:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-04-2021 11:55:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERED/RESOLVEDChanged Information
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915557
Page 153 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Mar-04-2021 11:49:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE fluid R ear:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 10:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915558
Page 154 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
decreased hearing R earInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 01:37:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-04-2021 11:57:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven Choi Query 2: Answered Per phone call on
04Mar21, this AE is
still recovering /
resolving.
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915559
Page 155 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Mar-03-2021 09:59:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened GPD CLINQUERY:
Please confirm if
AE is still ongoing
and without change
to severity or
identification of
cause.
Nov-11-2020 14:56:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-11-2020 14:23:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven Choi Query 1: Answered AE Lines 3-5 are
still ongoing; pt
plans on seeing an
ear specialist within
the next month or
so, as soon as their
new insurance kicks
in.
Nov-09-2020 14:33:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Grade 2
DECREASED
HEARING and
TINNITUS of
RIGHT EAR are
both reported as
ONGOING since
20SEP2020. Please
clarify if these AEs
remain ONGOING.
If RESOLVED,
please provide
STOP DATES and
update
OUTCOMES
accordingly.
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven Choi Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915560
Page 156 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown, possible allergyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) PacificACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915561
Page 157 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 10:24:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915562
Page 158 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 10:31:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Tinnitus R earTranscription Error
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
decreased hearing R earInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 01:39:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-04-2021 11:58:16 ACV0PFEINFP6000 Steven Choi Query 1: Answered Per phone call on
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915563
Page 159 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-08:00) Pacific
Time (US & Canada)04Mar21, this AE is
still ongoing w/o
change in severity.
Mar-03-2021 09:55:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPD CLINQUERY:
Please confirm if
AE is still ongoing
and without change
in severity.
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven Choi Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915564
Page 160 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unknown, possible allergyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 10:31:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RECOVERED/NOT RESO
LVEDTranscription Error
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915565
Page 161 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Oct-16-2020 10:25:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915566
Page 162 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 10:31:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
headacheTranscription Error
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
tinnitis R earInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 10:33:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/18/2020 18:00Transcription Error
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sep/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 10:33:40 ACV0PFEINFP6000 Steven Data Entry: Transcription Error
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915567
Page 163 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-08:00) Pacific
Time (US & Canada)Choi NO
End Date Time:
Sep/19/2020 10:00
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-16-2020 10:33:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RELATEDTranscription Error
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915568
Page 164 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
unknown, possible allergyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 10:34:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 10:34:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERED/RESOLVEDTranscription Error
Oct-16-2020 10:33:40 ACV0PFEINFP6000 auto query Query 1: Opened For AE headache:
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915569
Page 165 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-08:00) Pacific
Time (US & Canada)(autoquery) Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 10:29:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915570
Page 166 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Mar-05-2021
10:14:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Mar-05-2021
08:25:21
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged Information
Mar-05-2021
08:25:21
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Steven Choi Data
Entry
:
worse
ning
R TM
J dysf
unctio
nChanged Information
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915571
Page 167 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Mar-05-2021
00:45:35
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify WORSENING R
TMJ as follows...The term
appears incomplete. Are you
reporting WORSENING R
TMJ SYNDROME?
OSTEOARTHRITIS?
DISLOCATION? If so,
update the verbatim term as
such. Otherwise please
specify the corresponding
symptom or diagnosis being
reported for
TEMPOROMANDIBULAR
JOINT and update the
verbatim term accordingly.
Thank you.
Mar-04-2021
12:02:46
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Steven Choi Data
Entry
:
worse
ning
R TM
JInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/12/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
1Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915572
Page 168 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
TMJ 2/2 increased stress, ha
s a h/o TMJ dysfunctionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915573
Page 169 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-04-2021 12:02:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915574
Page 170 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 09:30:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/2/2021Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915575
Page 171 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 12:16:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 11:00:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-04-2021 09:30:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-04-2021 09:30:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven Choi Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915576
Page 172 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 12:16:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 12:16:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915577
Page 173 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 09:31:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/3/2021Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915578
Page 174 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-04-2021 09:32:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
OBTAINED
Date Written Consent Obtained
Feb/3/2021Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915579
Page 175 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-04-2021 09:34:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/3/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-04-2021 09:34:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-04-2021 09:34:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915580
Page 176 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/3/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915581
Page 177 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-04-2021 09:34:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NEGATIVEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915582
Page 178 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 09:34:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 09:34:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 09:37:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 09:34:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-04-2021 09:34:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 09:37:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BR54YFInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915583
Page 179 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 09:37:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BR54YFInitial Entry
5.b
Date Location User Value Reason
Feb-04-2021 09:37:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BR54YGInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-04-2021 09:37:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BR54YGInitial Entry
5.c
Date Location User Value Reason
Feb-04-2021 09:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BR54YHInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-04-2021 09:37:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BR54YHInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915584
Page 180 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 09:35:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 09:35:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 09:37:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 09:35:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-04-2021 09:35:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 09:37:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BR54YJInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915585
Page 181 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 09:37:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BR54YJInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915586
Page 182 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/3/2021 09:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) PacificACV0PFEINFP6000 Steven
ChoiData Entry:
RIGHTInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915587
Page 183 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-04-2021 09:35:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915588
Page 184 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 12:23:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/26/2021Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915589
Page 185 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/26/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915590
Page 186 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-26-2021 12:23:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NEGATIVEInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915591
Page 187 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 12:24:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 12:24:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 16:16:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 12:24:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 12:24:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 16:16:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Sample ID: BRMTLTInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915592
Page 188 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 16:16:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
BRMTLTInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915593
Page 189 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Feb/26/2021 08:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) PacificACV0PFEINFP6000 Steven
ChoiData Entry:
RIGHTInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915594
Page 190 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-26-2021 12:25:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
YESInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915595
Page 191 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020 10:15:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 10:35:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 10:27:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-16-2020 10:15:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Aug-28-2020 10:35:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020 10:27:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915596
Page 192 of 192
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network, LLC.
Subject No: 10541067 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-22-2020 11:58:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Steven
ChoiData Entry:
Click Here to EnableInitial Entry
090177e196d89027\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915597