125742 S1 M5 CRF c4591001 1149 11491239

Document text

Page 1 of 146
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811715
Page 2 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/15/2020
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811716
Page 3 of 146
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11491239]
2.Birth Date: /1953
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811717
Page 4 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811718
Page 5 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811719
Page 6 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811720
Page 7 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High blood pressure]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar fusion surgery (L1)]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.cLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811721
Page 8 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.dLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.eLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.fLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.gLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811722
Page 9 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [96.7]
3.Unit: kg
4.Height: [182.0]
5.Unit: cm
6.Body Mass Index: [29.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: FOREHEAD
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811723
Page 10 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [259243]
3.Randomization Group: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811724
Page 11 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BPV0ZG]
5.bSample ID [BPV0ZH]
5.cSample ID [BRVJSX]
5.dSample ID [BRVJSY]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811725
Page 12 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BPV0ZJ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811726
Page 13 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/15/2020 12:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811727
Page 14 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811728
Page 15 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811729
Page 16 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811730
Page 17 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811731
Page 18 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811732
Page 19 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811733
Page 20 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811734
Page 21 of 146
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811735
Page 22 of 146
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811736
Page 23 of 146
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811737
Page 24 of 146
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811738
Page 25 of 146
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811739
Page 26 of 146
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811740
Page 27 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811741
Page 28 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811742
Page 29 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811743
Page 30 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811744
Page 31 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811745
Page 32 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811746
Page 33 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811747
Page 34 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811748
Page 35 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811749
Page 36 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811750
Page 37 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811751
Page 38 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811752
Page 39 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Opioid dependence
withdrawal Jan/21/2021 U
NK:UNK NO
End Date Time:
Jan/26/2021 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  swollen lymph node
in right axilla Oct/5/2020 08:
00 NO
End Date Time:
Oct/12/2020 08:00
 Repeating
Pages
 3.ADVERSE
EVENT 3  Right arm pain with
motion Sep/22/2020 1
8:00 NO
End Date Time:
Sep/25/2020 20:00
 Repeating
Pages
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811753
Page 40 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Opioid dependence withdrawal]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/26/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811754
Page 41 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[medical]
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[2021037695]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811755
Page 42 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[swollen lymph node in right axilla]
4.Start Date Time: Oct/5/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/12/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811756
Page 43 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[adenopathy]
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[ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811757
Page 44 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[Right arm pain with motion]
4.Start Date Time: Sep/22/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/25/2020 20:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811758
Page 45 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811759
Page 46 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811760
Page 47 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811761
Page 48 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811762
Page 49 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: //
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811763
Page 50 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defi
ned Identifie
rCategory fo
r Medicatio
nConcomitant Medi
cations Pre-specifie
dName of
Medicatio
nDose De
scriptionForm Instan
ce
 1. DELETED   CORTICOS
TEROIDS     25  Repeating
Pages
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811764
Page 51 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen,
Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category: CORTICOSTEROIDS
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: [25]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Oct/1/2020
10.Ongoing? NO
End Date:
Oct/6/2020
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811765
Page 52 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811766
Page 53 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811767
Page 54 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811768
Page 55 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811769
Page 56 of 146
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811770
Page 57 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811771
Page 58 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811772
Page 59 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811773
Page 60 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811774
Page 61 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811775
Page 62 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811776
Page 63 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811777
Page 64 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811778
Page 65 of 146
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811779
Page 66 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811780
Page 67 of 146
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811781
Page 68 of 146
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811782
Page 69 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811783
Page 70 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811784
Page 71 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811785
Page 72 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status ENROLLED/RANDOMIZED
2.Subject Status Date Sep/15/2020
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811786
Page 73 of 146
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811787
Page 74 of 146
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811788
Page 75 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormSep-16-2020 14:28:43 (UTC-08:00)
Pacific Time (US & Canada)Not Applicable
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811789
Page 76 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-15-2020 12:48:26 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can perform
Visit 4 when he returns.
FormNov-15-2020 12:44:20 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can continue
with Visit 4 when he returns.
Not Done
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811790
Page 77 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-15-2020 12:44:20 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can continue
with Visit 4 when he returns.
Not Done
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811791
Page 78 of 146
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-15-2020 12:44:20 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can continue
with Visit 4 when he returns.
Not Done
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811792
Page 79 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-15-2020 12:48:38 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can perform
Visit 4 when he returns.
Not Done
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811793
Page 80 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Nov-15-2020 12:48:38 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can perform
Visit 4 when he returns.
Not Done
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811794
Page 81 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Nov-15-2020 12:48:38 (UTC-08:00)
Pacific Time (US & Canada)Patient unable to return to site until
January 2021 but still willing to continue
with study. Per monitor, pt can perform
Visit 4 when he returns.
Not Done
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811795
Page 82 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Nov-30-2020 11:38:40 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven
Reynolds Approved Nov-17-2020 17:17:46 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenReynolds, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-17-2020 14:30:07 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven
Reynolds Approved Nov-17-2020 12:36:55 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811796
Page 83 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
By my dated signature below, I, StevenReynolds, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 16:07:27 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven
Reynolds Approved Nov-16-2020 12:54:12 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenReynolds, verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-15-2020 12:44:20 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven
Reynolds Approved Nov-09-2020 17:52:59 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811797
Page 84 of 146
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Affidavit:
By my dated signature below, I, StevenReynolds, 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.
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811798
Page 85 of 146
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020
14:27:16
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-16-2020
14:27:16
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811799
Page 86 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020
14:27:27
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/15/2020Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811800
Page 87 of 146
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020 14:24:21
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11491239Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020
14:24:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020
14:27:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020
14:27:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPAN
ISH ORIGINInitial Entry
5. Race: (Check X all that apply):
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811801
Page 88 of 146
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-16-2020
14:27:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811802
Page 89 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020
11:22:21
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-07-2020
09:38:07
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Subject will
continue in
study.
Coordinator
scheduling
follow up visit.
Nov-05-2020
10:04:21
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened If subject is lost
to follow up,
please complete
disposition-
treatment and
disposition
follow up CRFs
to indicate that.
Thank you.
Sep-16-2020
14:28:01
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811803
Page 90 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-16-2020
14:29:37
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 14:29:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020
14:29:37
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811804
Page 91 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 14:31:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:High blood
pressure
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 14:31:43
(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
Sep-16-2020
14:31:43
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
High blood pressureInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020
14:31:43ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811805
Page 92 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific
Time (US &
Canada)
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020
14:31:43
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-16-2020
14:38:42
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:2
Medical
History
Term:Lumbar fusi
on surgery (
L1)
Start Da
te:UNK/UNK/
2018
Ongoing
:NO
End Date:
UNK/U
NK/2018Transcription
Error
Sep-16-2020
14:33:59
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Lumbar su
rgery (L1)Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811806
Page 93 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Start Date
:UNK/UN
K/2018
Ongoing: NO
End Date
:
UNK/U
NK/201
8
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811807
Page 94 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 14:33:59
(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
Sep-16-2020
14:38:42
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Lumbar fusion surgery
(L1)Transcription
Error
Sep-16-2020
14:33:59
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Lumbar surgery (L1)Initial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020
14:33:59
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020
14:33:59
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811808
Page 95 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US &
Canada) UNK/UNK/2018
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811809
Page 96 of 146
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
96.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
182.0Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811810
Page 97 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5. Unit:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020 14:40:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.2Initial Entry
7.a
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 36.5
Temperature
Unit:C
Temperature
Location::FOREH
EADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811811
Page 98 of 146
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a Temperature:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020
14:40:11
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811812
Page 99 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020
14:40:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020
14:40:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
259243Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811813
Page 100 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 14:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 14:41:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
07:50:44
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-17-2020
01:31:02
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
14:41:29
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811814
Page 101 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US &
Canada)barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
14:41:29
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
07:50:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPV0ZGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
07:50:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPV0ZGInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020
07:50:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPV0ZHInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0811815
Page 102 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Sample ID
Date Location User Value Reason
Sep-17-2020
07:50:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPV0ZHInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020
07:51:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVJSXInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020
07:51:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVJSXInitial Entry
5.d
Date Location User Value Reason
Sep-17-2020
07:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVJSYInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0811816
Page 103 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.d Sample ID
Date Location User Value Reason
Sep-17-2020
07:51:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVJSYInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0811817
Page 104 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 14:41:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 14:41:40
(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-17-2020
07:47:08
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-17-2020
01:31:02
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
14:41:40
(UTC-08:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811818
Page 105 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Pacific Time (US &
Canada)barcodes are
entered. Please
review and
correct as
appropriate.
Sep-16-2020
14:41:40
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
07:47:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPV0ZJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
07:47:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPV0ZJInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0811819
Page 106 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020
14:42:13
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 14:42:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 14:42:13
(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-16-2020
14:42:13
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 12:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811820
Page 107 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-16-2020 14:42:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020
14:42:13
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 14:42:13
(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-16-2020 14:42:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-16-2020
14:42:13
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811821
Page 108 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-16-2020
14:42:28
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811822
Page 109 of 146
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-07-2021
22:21:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query placed
on subject
status.
Nov-20-2020
03:32:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate To be followed
up till jan2021
Nov-15-2020
12:44:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-15-2020
12:44:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0811823
Page 110 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-15-2020
12:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-15-2020
12:48:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811824
Page 111 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811825
Page 112 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811826
Page 113 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-18-2021 09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811827
Page 114 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020
16:08:53
(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
Mar-10-2021
01:41:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opene
dSAE
RECON:AER#202103769,in
Safety database Drug
dependence was recorded as
separate entry. Please
consider to record Opioid
dependence as separate entry
for reconciliation with SDB
data.
Mar-04-2021
17:50:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Opioid depende
nce withdrawalNew Information
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811828
Page 115 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-19-2021
08:28:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Close
dResponse satisfies query
Feb-16-2021
12:23:06
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answ
eredSeriousness has been
updated.
Feb-15-2021
07:35:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reissu
ed:OpenedThis event has been report
has serious (resulted in
hospitalization). Please
review and update
seriousness accordingly.
Thanks
Feb-12-2021
16:39:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription Error
Feb-12-2021
16:39:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Heart AttackTranscription Error
Feb-02-2021
16:34:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reissu
ed:Openedthanks for confirming.
However, AER#2021037695
has already been submitted
to safety. Pls clarify.
Jan-27-2021
21:23:41
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Query 1: Answ
eredThe information is pending
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811829
Page 116 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
Jan-27-2021
06:54:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Opene
dAn SAE of "Heart attack"
has been reported to safety.
Please review and update
AE log accordingly. Thanks.
Nov-16-2020
16:08:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Right arm pain
with motionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021
01:47:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed SDB updated
Mar-07-2021
23:29:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
CandidatePending SDB update
Mar-04-2021
17:45:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription Error
Mar-04-2021
17:45:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021 UNK:
UNKTranscription Error
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811830
Page 117 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-23-2021
22:48:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021037695 ,onset
date was blank in Safety
database however,
recorded as 22Sep2020
on AE CRF. Please
confirm correct Onset
Date. If safety update is
required, please submit
a follow-up SAE form.
Nov-16-2020
16:08:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
17:46:38
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-04-2021
17:46:38
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/26/2021 UNK:U
NKTranscription
Error
Mar-04-2021
17:45:59
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Heart Attack
End Date &
Time
25/Sep/2020
20:00 is before
the Start Date &
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811831
Page 118 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time
21/Jan/2021
UNK:UNK.
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/25/2020 20:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-17-2021
19:30:37
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Feb-16-2021
12:22:48
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-16-2021
12:22:48
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
4Transcription
Error
Feb-15-2021
12:05:24
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: As
this was a SAE,
please
re-evaluate the
grade.
Nov-16-2020
16:08:53
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811832
Page 119 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US &
Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021
22:48:16
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-16-2021
12:22:34
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Heart
Attack:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Feb-16-2021
12:22:34
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event as
sociated with congenit
al anomaly or birth def
ect?
NO
Did this serious event
result in death?Transcription
Error
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811833
Page 120 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Did this serious event
require or prolong hos
pitalization?
YES
Did this serious event
result in persistent or s
ignificant disability/in
capacity?
NO
Is this serious event lif
e threatening?
YES
Other medically impor
tant serious event
NO
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811834
Page 121 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US &
Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-17-2021
19:25:26
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Feb-16-2021
12:21:13
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-16-2021
12:21:13
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:
medicalTranscription
Error
Feb-15-2021
12:04:31
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Per
SAE report
2021037695, the
SAE was not
study drug
related. If that is
correct, please
revise the
answer and
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811835
Page 122 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
provide the
suspected cause
for this SAE.
Nov-16-2020
16:08:53
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811836
Page 123 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021
01:47:45
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedSDB updated
Mar-07-2021
23:29:43
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Reissued:
CandidatePending SDB update
Mar-04-2021
17:51:06
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answeredrecovered and had been reconciled
Feb-23-2021
22:49:49
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2021037695,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Nov-16-2020
16:08:53
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
RECOVE
RED/RES
OLVEDInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811837
Page 124 of 146
***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, Queries, Frozen
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020
16:08:53
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-16-2021
22:48:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021037695Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811838
Page 125 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020
16:10:25
(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 ValueReason
Nov-17-2020
16:28:09
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Nov-17-2020
14:30:07
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Nov-17-2020 ACV0PFEINFP6000  DataTranscription
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811839
Page 126 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14:30:07
(UTC-08:00)
Pacific Time
(US &
Canada)Entry
:
swoll
en ly
mph n
ode in
right
axillaError
Nov-17-2020
12:53:03
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedMultiple
concepts in
the term
LUMBAR
SURGERY
FOR BACK
PAIN. Split
the term into
LUMBAR
SURGERY
and BACK
PAIN and
report as
separate
entries.
Thank you.
Nov-17-2020
09:54:08
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
lumba
r surg
ery fo
r back
painTranscription
Error
Nov-16-2020
16:10:25
(UTC-08:00)
Pacific Time
(US &ACV0PFEINFP6000  Data
Entry
:
Swoll
en lyInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811840
Page 127 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Canada) mph n
ode in
right
axilla
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/12/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data 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
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811841
Page 128 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event i
s due to:
OTHER
If Other, specify:
adenopathyInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811842
Page 129 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811843
Page 130 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Nov-16-2020
16:10:25
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811844
Page 131 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 09:16:42
(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
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right arm pain with motio
nInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811845
Page 132 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/25/2020 20:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data 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
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811846
Page 133 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811847
Page 134 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021
09:16:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811848
Page 135 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-30-2020
11:39:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Deleted per
query stating
meds not
taken more
than 14 days.
Not
prohibited.
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811849
Page 136 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen,
Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-30-2020
11:38:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Prednisone
removed per
query.
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
CORTICOSTEROIDSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-30-2020
11:38:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Prednisone
removed per
query.
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811850
Page 137 of 146
***Confidential***
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).
Date Location User Value Reason
Dec-01-2020
18:04:47
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-30-2020
11:38:40
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Prednisone
removed per
query.
Nov-30-2020
11:38:40
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry: Prednisone
removed per
query.
Nov-26-2020
16:56:12
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Reissued:Ope
nedClinQuery:
Please be
informed that the
MH page is
unfrozen. please
update
accordingly.
Thanks! Please
be noticed that
Prednisone is
used from Oct 1
to Oct 6, which
is less than 14
days. So this
does not qualify
as prohibited and
should be
removed.
Nov-25-2020
12:31:02
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze
medical history
in Visit 1 to
update.
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0811851
Page 138 of 146
***Confidential***
Nov-22-2020
23:01:49
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
[Prednisone]
This does not
qualify as
prohibited per
the protocol i.e.,
=20 mg/day for
=14 days
(section 6.5.1).
Please review
and action
appropriately.
Please consider
listing condition
that required
treatment on
medical history.
Nov-22-2020
16:32:28
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Query 1: Candidate ClinQuery:
[Prednisone]
This does not
qualify as
prohibited per
the protocol i.e.,
=20 mg/day for
=14 days
(section 6.5.1).
Please review
and action
appropriately.
Please consider
listing condition
that required
treatment on
medical history.
Nov-16-2020
16:07:27
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
PrednisoneInitial Entry
5. Dose:
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
25Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0811852
Page 139 of 146
***Confidential***
Time (US &
Canada)
6. Dose Unit:
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
mgInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
QDInitial Entry
8. Route:
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ORALInitial Entry
9. Start Date:
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
10. Ongoing?
Date Location User Value Reason
Nov-16-2020
16:07:27
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0811853
Page 140 of 146
***Confidential***
Time (US &
Canada) Oct/6/2020
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
FDA-CBER-2021-5683-0811854
Page 141 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-08-2021
00:00:02
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Mar-05-2021
13:57:56
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered subject still
continuing in
study
Mar-01-2021
03:47:42
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Reissued:Ope
nedDM: As 'visits 2
and 3 have not
been conducted.,
please confirm if
the subject is
continuing in the
study. Kindly
review and
update 'DISP
TRT' form at
EOT visit.
Feb-17-2021
22:33:01
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Reissued:Cand
idateIt will be tracked
per site response.
Feb-17-2021
14:33:40
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered Subject is still
out of town, and
visits 2 and 3
have not been
conducted.
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811855
Page 142 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-16-2021
21:16:29
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Reissued:Ope
nedDM1: Per
previous
response 'V2 and
V3 have been
delayed to an
undetermined
date'. Please
follow-up and
confirm if
subject visit V2
and V3 have
been done or not.
Please update as
appropriate or
clarify.
Jan-25-2021
01:20:06
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Reissued:Cand
idateDM: Please
update when data
is available.
Thank you
Jan-22-2021
10:49:35
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered Subject is
currently
hospitalized, thus
V2 and V3 have
been delayed to
an undetermined
date.
Jan-07-2021
22:20:56
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened DM: Per
previous query
"Subject is still
in the study,
however, will be
unable to return
until January.
Approved per
study team. V2
and V3 will not
be done." Kindly
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811856
Page 143 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
review and
confirm if
subject visit is
scheduled?.
Nov-15-2020
13:41:38
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed per site's
response, will
close query.
Nov-15-2020
12:43:14
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Subject is still in
the study,
however, will be
unable to return
until January.
Approved per
study team. V2
and V3 will not
be done.
Nov-14-2020
08:21:02
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened DM: V2 is
missing. Please
confirm is
subject is still in
the study? If so,
please confirm
when V2 is
expected to
occur. If not,
please complete
DISP TRT and
DISP FUP.
Sep-16-2020
14:40:41
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-16-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0811857
Page 144 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14:29:37
(UTC-08:00) Pacific
Time (US &
Canada)(autocalc) SCREENED
2. Subject Status Date
Date Location User Value Reason
Feb-15-2021
09:29:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Feb-12-2021
16:41:40
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answer
edAE has been updated will
submit a follow up once we
receive medical records
Feb-08-2021
11:57:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2021037695
heart attack was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Jan-25-2021
05:54:29
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed event no longer listed in
SDB
Jan-21-2021
02:52:06
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021037695
heart attack was reported as
serious in Safety database
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0811858
Page 145 of 146
***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: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Sep-16-2020
14:40:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Sep-16-2020
14:29:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811859
Page 146 of 146
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1149 Site Name: (1149) Collaborative Neuroscience Network, LLC.
Subject No: 11491239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-09-2020
14:38:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae30c7\Final\Final On: 01-Apr-2021 04:16 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811860