125742 S1 M5 CRF c4591001 1054 10541168

Document text

Page 1 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915598
Page 2 of 164
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/17/2020
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915599
Page 3 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10541168]
2.Birth Date: /1956
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0915600
Page 4 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915601
Page 5 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915602
Page 6 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915603
Page 7 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cesarean section]
Start Date: Mar/22/1976
Ongoing: NO
End Date:
Mar/22/1976
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[abdominal surgical scar]
Start Date: Mar/22/1976
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915604
Page 8 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[mild intermittent headacheq]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[post-menopause]
Start Date: UNK/UNK/1990
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cesarean section]
Start Date: Oct/26/1979
Ongoing: NO
End Date:
Oct/26/1979
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915605
Page 9 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915606
Page 10 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
2.Weight: [82.73]
3.Unit: kg
4.Height: [144.78]
5.Unit: cm
6.Body Mass Index: [39.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915607
Page 11 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915608
Page 12 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/17/2020
2.Randomization Number: [261401]
3.Randomization Group: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915609
Page 13 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BM98TH]
5.bSample ID [BM98TJ]
5.cSample ID [BM98TK]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915610
Page 14 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BM98TL]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915611
Page 15 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/17/2020 12:59
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
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915612
Page 16 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915613
Page 17 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915614
Page 18 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915615
Page 19 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915616
Page 20 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYX0M]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915617
Page 21 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/8/2020 08:33
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
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915618
Page 22 of 164
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915619
Page 23 of 164
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BM98BK]
5.bSample ID [BM98BL]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915620
Page 24 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915621
Page 25 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915622
Page 26 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915623
Page 27 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915624
Page 28 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915625
Page 29 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915626
Page 30 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915627
Page 31 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915628
Page 32 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915629
Page 33 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915630
Page 34 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915631
Page 35 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915632
Page 36 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915633
Page 37 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915634
Page 38 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915635
Page 39 of 164
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915636
Page 40 of 164
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915637
Page 41 of 164
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915638
Page 42 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse
Event Still Ong
oingForm Insta
nce
 1.ADVERS
E EVEN
T 1 closed fracture, transvers
e process of lumbar vert
ebra Dec/3/2020
UNK:UNK
 YES  Repeating
Pages
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915639
Page 43 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[closed fracture, transverse process of lumbar vertebra]
4.Start Date Time: Dec/3/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915640
Page 44 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
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:
[pedestrian vs motor vehicle accident]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915641
Page 45 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021067301]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915642
Page 46 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915643
Page 47 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915644
Page 48 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915645
Page 49 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915646
Page 50 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915647
Page 51 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915648
Page 52 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915649
Page 53 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915650
Page 54 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915651
Page 55 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915652
Page 56 of 164
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915653
Page 57 of 164
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915654
Page 58 of 164
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915655
Page 59 of 164
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915656
Page 60 of 164
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915657
Page 61 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915658
Page 62 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915659
Page 63 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915660
Page 64 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915661
Page 65 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915662
Page 66 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915663
Page 67 of 164
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915664
Page 68 of 164
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915665
Page 69 of 164
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915666
Page 70 of 164
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915667
Page 71 of 164
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915668
Page 72 of 164
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915669
Page 73 of 164
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/5/2020
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915670
Page 74 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915671
Page 75 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915672
Page 76 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-17-2020 13:50:23 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915673
Page 77 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915674
Page 78 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915675
Page 79 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915676
Page 80 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915677
Page 81 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915678
Page 82 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915679
Page 83 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915680
Page 84 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915681
Page 85 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-08-2020 11:23:28 (UTC-08:00)
Pacific Time (US & Canada)Steven Choi Not Applicable
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915682
Page 86 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-26-2021 06:36:49 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mark
Leibowitz Approved Jan-25-2021 10:03:19 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkLeibowitz, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Steven Choi  N/A Jan-22-2021 14:55:30 (UTC-08:00)
Pacific Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0915683
Page 87 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Mark
Leibowitz Approved Nov-11-2020 10:06:28 (UTC-08:00)
Pacific Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarkLeibowitz, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915684
Page 88 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-17-2020
13:48:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-17-2020
13:48:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915685
Page 89 of 164
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020
13:49:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/17/2020Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915686
Page 90 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020
13:48:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10541168Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020
13:48:36
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1956Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020
13:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915687
Page 91 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
HISPANIC OR LATI
NO(A) OR OF SPANI
SH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020
13:49:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
WHITEInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915688
Page 92 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020
13:50:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/17/2020Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915689
Page 93 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-17-2020
13:51:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020
13:51:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020
13:51:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915690
Page 94 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020
13:53:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Cesarean
section
Start Date: Mar/22/1
976
Ongoing: NO
End Dat
e:
Mar/22
/1976Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020
13:53:33
(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:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915691
Page 95 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-17-2020
13:53:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Cesarean sectionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-17-2020
13:53:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Mar/22/1976Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020
13:53:33
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date:
Mar/22/1976Initial Entry
1.b
Date Location User Value Reason
Sep-17-2020
13:53:59
(UTC-08:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH 2Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915692
Page 96 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)Number:
Medical H
istory Ter
m:abdominal
surgical sc
ar
Start Date
:Mar/22/19
76
Ongoing: YES
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915693
Page 97 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020
13:53:59
(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-17-2020
13:53:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
abdominal surgical sc
arInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020
13:53:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Mar/22/1976Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915694
Page 98 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:53:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-17-2020
13:54:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:obesity
Start Date: UNK/U
NK/199
5
Ongoing: YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915695
Page 99 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-17-2020
13:54:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
13:54:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
obesityInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-17-2020
13:54:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/1995Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915696
Page 100 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:54:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-17-2020
13:54:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:mild inter
mittent hea
dacheq
Start Dat
e:UNK/UNK
/2018
Ongoing: YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915697
Page 101 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-17-2020
13:54:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
13:54:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
mild intermittent head
acheqInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-17-2020
13:54:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915698
Page 102 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:54:27
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-17-2020
13:55:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:post-me
nopause
Start Date: UNK/U
NK/199
0
Ongoing: YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915699
Page 103 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-17-2020
13:55:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
13:55:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
post-menopauseInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-17-2020
13:55:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915700
Page 104 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:55:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-17-2020
14:21:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical Hi
story Term
:Cesarean
section
Start Date: Oct/26/19
79
Ongoing: NO
End Dat
e:
Oct/26
/1979Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915701
Page 105 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-17-2020
14:21:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
14:21:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Cesarean sectionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-17-2020
14:21:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/26/1979Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915702
Page 106 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
14:21:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO
End Date:
Oct/26/1979Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915703
Page 107 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-17-2020
13:55:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
The subject is NOT k
nown to be HIV POSI
TIVEInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915704
Page 108 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
82.73Initial Entry
3. Unit:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
kgInitial Entry
4. Height:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915705
Page 109 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
144.78Initial Entry
5. Unit:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
39.5Initial Entry
7.a
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)ACV0PFEINFP6000  Steven
ChoiData Entry:
Record Ide 1Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915706
Page 110 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)ntifier::
Temperatu
re:99.0
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915707
Page 111 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
13:56:37
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915708
Page 112 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915709
Page 113 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
EInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915710
Page 114 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Not Done
::
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020
13:56:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NEGATIVEInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915711
Page 115 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-17-2020
13:57:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-17-2020
13:57:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
261401Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915712
Page 116 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
13:57:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
13:57:18
(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
15:13:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
13:57:18ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915713
Page 117 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
13:57:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
15:13:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID
:BM98T
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
15:13:14
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98THInitial Entry
5.b
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915714
Page 118 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-17-2020
15:13:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID: BM98TJInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020
15:13:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98TJInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020
15:13:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID
:BM98T
KInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915715
Page 119 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-17-2020
15:13:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98TKInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915716
Page 120 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
13:57:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
13:57:25
(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
15:13:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
13:57:25ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915717
Page 121 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
13:57:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
15:13:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID
:BM98T
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
15:13:55
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98TLInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915718
Page 122 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915719
Page 123 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sep/17/2020 12:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
13:58:01
(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-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915720
Page 124 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-17-2020
13:58:01
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915721
Page 125 of 164
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-17-2020
13:58:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915722
Page 126 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020
11:21:48
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/8/2020Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915723
Page 127 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020
11:22:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/8/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020
11:22:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Record Ide
ntifier::1
Temperatu
re:98.3
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-08-2020
11:22:08
(UTC-08:00)ACV0PFEINFP6000  Steven
ChoiData Entry:
1Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915724
Page 128 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-08-2020
11:22:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-08-2020
11:22:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-08-2020
11:22:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ORAL CAVITYInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915725
Page 129 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-08-2020
11:22:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915726
Page 130 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
11:22:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
Oct-08-2020
11:22:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription
Error
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/8/2020Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915727
Page 131 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-08-2020
11:22:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Oct-08-2020
11:22:50
(UTC-08:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915728
Page 132 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:Not Appli
cable
Test:: Choriogon
adotropin
Beta_PX1
13
Result:: Not Appli
cable
Not Don
e::Not Appli
cableInitial Entry
Oct-08-2020
11:23:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:Transcription
Error
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915729
Page 133 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Test:: Choriogon
adotropin
Beta_PX1
13
Result::
Not Don
e::
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined
Identifie
r:113
Test:: Choriogon
adotropin
Beta_PX1
13
Result:: NEGATIV
E
Not Don
e::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915730
Page 134 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
11:23:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription
Error
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
Oct-08-2020
11:23:09
(UTC-08:00)ACV0PFEINFP6000  Steven
ChoiData Entry: Transcription
Error
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915731
Page 135 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Pacific Time (US
& Canada)
Oct-08-2020
11:22:21
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-08-2020
11:23:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Not ApplicableInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915732
Page 136 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
11:23:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
11:23:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020
14:54:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-08-2020
11:23:47ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915733
Page 137 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-08-2020
11:23:47
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020
14:54:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID
:BPYX0
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020
14:54:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BPYX0MInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915734
Page 138 of 164
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915735
Page 139 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Oct/8/2020 08:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915736
Page 140 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-08-2020
11:24:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915737
Page 141 of 164
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020
08:42:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Nov/5/2020Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915738
Page 142 of 164
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020
08:43:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020
08:43:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020
13:53:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-05-2020
08:43:02ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915739
Page 143 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-05-2020
08:43:02
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020
13:53:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID
:BM98B
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020
13:53:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98BKInitial Entry
5.b
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915740
Page 144 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-05-2020
13:54:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Sample ID
:BM98B
LInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-05-2020
13:54:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
BM98BLInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915741
Page 145 of 164
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000 Steven
ChoiForm Created
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915742
Page 146 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021
14:55:30
(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-09-2021
10:24:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
closed fracture, tra
nsverse process of l
umbar vertebraChanged
Information
Feb-25-2021
20:38:29ACV0PFEINFP6000  Query 1: Closed Query closed;
will follow for
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915743
Page 147 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-08:00)
Pacific Time (US
& Canada)requested
vertebral body
# information.
Feb-25-2021
14:15:20
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Query 1: Answered Per latest SAE
f/u submission
on 25Feb21,
specifics on
lumbar
vertebral fx
still unknown,
as med recs
from pt's
hospital stay
are still
pending.
Jan-26-2021
06:02:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Please
specify which
lumbar
vertebral body
was fractured,
in both AE and
in SAE safety
update
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
lumbar vertebral fr
actureInitial Entry
4. Start Date Time:
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915744
Page 148 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Dec/3/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
3Initial 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
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915745
Page 149 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-28-2021
17:44:08
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 3: Closed Query closed;
will follow for
requested
COVID test
information.
Feb-26-2021
08:17:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Query 3: Answer
edThe SAE f/u
submitted
yesterday on
25-Feb-21 has
that information.
If submission is
inadequate,
please indicate
why to us (site
#1054) it is so.
Feb-25-2021
20:38:56
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 3: Reissue
d:OpenedClinical – Thank
you. If NO
hospital COVID
test was
performed is
known, please
submit this
information on a
follow-up SAE
form, as
pertinent
information for
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915746
Page 150 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
this trial.
Feb-25-2021
14:16:42
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Query 3: Answer
edPer latest SAE
f/u submission
on 25Feb21, pt
did not get a
COVID test
during their
hospitalization.
Jan-26-2021
06:37:17
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Jan-26-2021
06:03:24
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 3: Opened Clinical COVID
test status
(yes/no) during
Hosp and Rehab
stay was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021067301]
to document if
COVID testing
was performed
(YES/NO or info
not available)
and if yes, the
date and results.
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915747
Page 151 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-25-2021
08:22:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Query 2: Answer
edAs written; this
SAE report was
confirmed as
sent on
22Jan2021 @
12:57:07 pm
PST from site's
fax number
(local ID =
12133534642).
Jan-25-2021
05:18:43
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
lumbar vertebral
fracture(Onset
date:03Dec2020)
is not reported to
Safety database
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE
CRF
Jan-25-2021
05:17:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915748
Page 152 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teFor AE lumbar
vertebral
fracture:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven Choi Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915749
Page 153 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Did this serious
event result in p
ersistent or sign
ificant disability
/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medically
important serio
us event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915750
Page 154 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
pedestrian vs m
otor vehicle acci
dentInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915751
Page 155 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-22-2021
14:55:30
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915752
Page 156 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-26-2021
06:36:49
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2021067301Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0915753
Page 157 of 164
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-05-2020
08:43:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020
08:43:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-05-2020
08:43:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
COMPLETEDInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915754
Page 158 of 164
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
09:44:51
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Feb/4/2021Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915755
Page 159 of 164
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-10-2021
09:45:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
09:45:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-10-2021
09:45:00
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915756
Page 160 of 164
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
lacebo at Vaccina
tion 1/2
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915757
Page 161 of 164
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-10-2021
09:45:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Feb/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-10-2021
09:45:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915758
Page 162 of 164
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-05-2020
08:43:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-17-2020
13:57:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-17-2020
13:51:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-05-2020
08:43:28
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/5/2020Initial Entry
Sep-17-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915759
Page 163 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
13:57:12
(UTC-08:00)
Pacific Time (US
& Canada)(autocalc) Sep/17/2020
Sep-17-2020
13:51:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/17/2020Initial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0915760
Page 164 of 164
***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: 1054 Site Name: (1054) Collaborative Neuroscience Network,
LLC.
Subject No: 10541168 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-23-2020
10:24:41
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Steven
ChoiData Entry:
Click Here to EnableInitial Entry
090177e196ae30e4\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0915761