125742 S1 M5 CRF c4591001 1013 10131386

Document text

Page 1 of 117
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137826
Page 2 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137827
Page 3 of 117
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131386]
2.Birth Date: 1960
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137828
Page 4 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137829
Page 5 of 117
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137830
Page 6 of 117
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137831
Page 7 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[RIGHT KNEE ACL REPAIR]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ACL TEAR RIGHT KNEE]
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
UNK/UNK/1980
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137832
Page 8 of 117
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [96.8]
3.Unit: kg
4.Height: [187.9]
5.Unit: cm
6.Body Mass Index: [27.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137833
Page 9 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [248165]
3.Randomization Group: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137834
Page 10 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPC3NM]
5.bSample ID [BPC3NN]
5.cSample ID [BPC3NP]
5.dSample ID [BMN519]
5.eSample ID [BMN51B]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137835
Page 11 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BN6241]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137836
Page 12 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/1/2020 10:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137837
Page 13 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137838
Page 14 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137839
Page 15 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137840
Page 16 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/22/2020
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 [BPC33S]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137841
Page 17 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/22/2020 09:55
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
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137842
Page 18 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137843
Page 19 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRC8FV]
5.bSample ID [BRC8FW]
5.cSample ID [BRC8FX]
5.dSample ID [BMN5HW]
5.eSample ID [BMN5HX]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137844
Page 20 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137845
Page 21 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137846
Page 22 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137847
Page 23 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137848
Page 24 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137849
Page 25 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137850
Page 26 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137851
Page 27 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137852
Page 28 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137853
Page 29 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137854
Page 30 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137855
Page 31 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137856
Page 32 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137857
Page 33 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137858
Page 34 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137859
Page 35 of 117
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137860
Page 36 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137861
Page 37 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137862
Page 38 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137863
Page 39 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137864
Page 40 of 117
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137865
Page 41 of 117
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137866
Page 42 of 117
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137867
Page 43 of 117
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137868
Page 44 of 117
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137869
Page 45 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: //
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137870
Page 46 of 117
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137871
Page 47 of 117
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137872
Page 48 of 117
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137873
Page 49 of 117
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137874
Page 50 of 117
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137875
Page 51 of 117
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137876
Page 52 of 117
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137877
Page 53 of 117
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137878
Page 54 of 117
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137879
Page 55 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137880
Page 56 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137881
Page 57 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137882
Page 58 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137883
Page 59 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137884
Page 60 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137885
Page 61 of 117
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137886
Page 62 of 117
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137887
Page 63 of 117
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137888
Page 64 of 117
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137889
Page 65 of 117
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137890
Page 66 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137891
Page 67 of 117
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137892
Page 68 of 117
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia
Brown Approved Oct-26-2020 10:36:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, 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.
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137893
Page 69 of 117
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-01-2020 16:38:02 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137894
Page 70 of 117
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Patricia
Brown Approved Oct-26-2020 10:36:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PatriciaBrown, 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.
Matthew
Stephens N/A Oct-20-2020 10:44:52 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Oct-06-2020 07:26:21 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137895
Page 71 of 117
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, MichaelDever, 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.
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137896
Page 72 of 117
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020
16:37:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020
16:37:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137897
Page 73 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020
16:37:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/1/2020Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137898
Page 74 of 117
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020
16:37:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10131386Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020
16:37:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1960Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020
16:37:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
(b) (6)
FDA-CBER-2021-5683-0137899
Page 75 of 117
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020
16:37:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020
16:37:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
WHITEInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137900
Page 76 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020
16:37:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137901
Page 77 of 117
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137902
Page 78 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020
16:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:1
Medical
History
Term:RIGHT KN
EE ACL RE
PAIR
Start Da
te:UNK/UNK/
1980
Ongoing
:NO
End Date:
UNK/UN
K/1980Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020
16:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137903
Page 79 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020
16:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
RIGHT KNEE AC
L REPAIRInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020
16:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/1980Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020
16:38:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
1.b
Date Location User Value Reason
Sep-01-2020
16:38:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137904
Page 80 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical
History
Term:ACL TEAR
RIGHT KN
EE
Start Dat
e:UNK/UNK/
1978
Ongoing
:NO
End Date:
UNK/U
NK/1980
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137905
Page 81 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020
16:38:49
(UTC-05:00)
Eastern 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-01-2020
16:38:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ACL TEAR RIGH
T KNEEInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020
16:38:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/1978Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020
16:38:49ACV0PFEINFP6000  Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137906
Page 82 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) End Date:
UNK/UNK/1980
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137907
Page 83 of 117
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
96.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137908
Page 84 of 117
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
187.9Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.4Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.8Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137909
Page 85 of 117
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137910
Page 86 of 117
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
16:39:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137911
Page 87 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020
16:39:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020
16:39:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
248165Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137912
Page 88 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
16:39:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
16:39:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
17:13:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
16:39:28
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137913
Page 89 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
16:39:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
17:13:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC3N
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
17:13:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC3NMInitial Entry
5.b
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137914
Page 90 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-01-2020
17:13:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC3N
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020
17:13:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC3NNInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
17:13:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC3N
PInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137915
Page 91 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Sep-01-2020
17:13:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC3NPInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020
17:14:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BMN51
9Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-01-2020
17:14:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN519Initial Entry
5.e
Date Location User Value Reason
Sep-01-2020
17:14:09ACV0PFEINFP6000  Matthew
StephensData Entry:
Sample I BMN51Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137916
Page 92 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: B
5.e Sample ID
Date Location User Value Reason
Sep-01-2020
17:14:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN51BInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137917
Page 93 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
16:39:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
16:39:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
17:14:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
16:39:34
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137918
Page 94 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
16:39:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
17:14:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BN624
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
17:14:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BN6241Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137919
Page 95 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137920
Page 96 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/1/2020 10:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137921
Page 97 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
16:39:47
(UTC-05:00)
Eastern 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-01-2020
16:39:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137922
Page 98 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-01-2020
16:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTED
FOR THIS SUBJE
CTInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137923
Page 99 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020
12:13:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/22/2020Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137924
Page 100 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
12:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
12:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.7
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
12:13:23
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137925
Page 101 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-22-2020
12:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
12:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
12:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137926
Page 102 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020
12:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020
12:13:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020
15:53:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
12:13:30
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137927
Page 103 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-22-2020
12:13:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020
15:53:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC33
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
15:53:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC33SInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137928
Page 104 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137929
Page 105 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sep/22/2020 09:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137930
Page 106 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020
12:13:46
(UTC-05:00)
Eastern 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-22-2020
12:13:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137931
Page 107 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020
01:30:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response
satisfies query
Nov-09-2020
13:39:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 1: Answer
edCRC WILL
UPDATE
WITH DCF.
Nov-09-2020
13:12:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Query 1: Reissue
d:OpenedIll ediary:
Thanks for the
response,
however he
Data in the
Ediary is YES
for
03NOV2020.
Please enter a
COVID Illness
Visit or
consider raising
DCF to correct
eDiary data.
Nov-09-2020
09:02:55
(UTC-05:00)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 1: Answer
edCRC HAS
LEFT
MESSAGES
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137932
Page 108 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)FOR
SUBJECT TO
CONFIRM
SYMPTOMS.
Nov-08-2020
04:28:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Sharat Nair
(pfe.nairs51)Query 1: Opened Illness ediary:
As per Illness
ediary records,
subject
reported "Yes"
for the question
"Have you
experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
03NOV2020.
But
corresponding
COVID Illness
visit not
reported. Please
clarify.
Oct-20-2020
10:44:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/20/2020Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137933
Page 109 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020
10:44:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020
10:44:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
00:33:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Ankita Thakur
(pfe.thakua20)Query 1: Closed Response
satisfies query.
Oct-20-2020
11:06:34
(UTC-05:00)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Query 1: Answere
dwill update
today when
barcodes are
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137934
Page 110 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)received from
lab.
Oct-20-2020
10:49:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe.nairr29)Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
10:44:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-20-2020
10:44:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020
16:44:11
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRC8F
VInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137935
Page 111 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
16:44:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRC8FVInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020
16:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRC8F
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020
16:44:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRC8FWInitial Entry
5.c
Date Location User Value Reason
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137936
Page 112 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-20-2020
16:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRC8F
XInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020
16:44:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BRC8FXInitial Entry
5.d
Date Location User Value Reason
Oct-20-2020
16:44:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BMN5H
WInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-20-2020
16:44:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN5HWInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137937
Page 113 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.e
Date Location User Value Reason
Oct-20-2020
16:44:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BMN5H
XInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-20-2020
16:44:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
BMN5HXInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137938
Page 114 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-20-2020
10:45:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020
10:45:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020
10:45:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137939
Page 115 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020
10:45:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-01-2020
16:39:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-01-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020
10:45:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Sep-01-2020
16:39:21ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137940
Page 116 of 117
***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: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-01-2020
16:38:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137941
Page 117 of 117
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131386 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-23-2020
14:42:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Monica
Cooper
(pfe.mcooper)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f60\Final\Final On: 01-Apr-2021 03:41 (GMT)
FDA-CBER-2021-5683-0137942