Document text
Page 1 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138550
Page 2 of 176
***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: 10131653 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
Oct/7/2020
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138551
Page 3 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10131653]
2.Birth Date: /2003
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138552
Page 4 of 176
***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: 10131653 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/7/2020
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138553
Page 5 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138554
Page 6 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
/DeathOct/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138555
Page 7 of 176
***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: 10131653 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:[ASTHMA]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ATTENTION DEFICIT HYPERACTIVITY DISORDER]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CHARCOT MARIE TOOTH]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138556
Page 8 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[OBESITY]
Start Date: UNK/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ANKLE FRACTURE RIGHT]
Start Date: Sep/11/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ACHILLES TENDON RIGHT AND LEFT RELEASE]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138557
Page 9 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ACHILLES TENDON RIGHT AND LEFT RELEASE]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138558
Page 10 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138559
Page 11 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
2.Weight: [102.7]
3.Unit: kg
4.Height: [155.0]
5.Unit: cm
6.Body Mass Index: [42.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138560
Page 12 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/7/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138561
Page 13 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/7/2020
2.Randomization Number: [104654]
3.Randomization Group: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138562
Page 14 of 176
***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: 10131653 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/7/2020
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 [BPC2KH]
5.bSample ID [BPC2KJ]
5.cSample ID [BPC2KK]
5.dSample ID [BS6ZD6]
5.eSample ID [BS6ZD7]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138563
Page 15 of 176
***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: 10131653 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:
Oct/7/2020
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 [BRG2TS]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138564
Page 16 of 176
***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: 10131653 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: Oct/7/2020 12:09
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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138565
Page 17 of 176
***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: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138566
Page 18 of 176
***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: 10131653 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/27/2020
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138567
Page 19 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138568
Page 20 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/27/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138569
Page 21 of 176
***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: 10131653 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:
Oct/27/2020
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 [BR9TJR]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138570
Page 22 of 176
***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: 10131653 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: Oct/27/2020 14:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138571
Page 23 of 176
***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: 10131653 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 Nov/24/2020
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138572
Page 24 of 176
***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: 10131653 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:
Nov/24/2020
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 [1BS0JHD ]
5.bSample ID [BS0JHD]
5.cSample ID [BS0JHF]
5.dSample ID [BRHW34]
5.eSample ID [BRHW35]
5.fSample ID [BRHW36]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138573
Page 25 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138574
Page 26 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138575
Page 27 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138576
Page 28 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138577
Page 29 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138578
Page 30 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138579
Page 31 of 176
***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: 10131653 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:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138580
Page 32 of 176
***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: 10131653 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: [ ]
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FDA-CBER-2021-5683-0138581
Page 33 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138582
Page 34 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138583
Page 35 of 176
***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: 10131653 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?
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138584
Page 36 of 176
***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: 10131653 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:
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FDA-CBER-2021-5683-0138585
Page 37 of 176
***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: 10131653 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:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138586
Page 38 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138587
Page 39 of 176
***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: 10131653 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:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138588
Page 40 of 176
***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: 10131653 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 [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138589
Page 41 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138590
Page 42 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138591
Page 43 of 176
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse
Event Still On
goingForm Insta
nce
1.ADVER
SE EVE
NT 1 RIGHT LOWER EXTRE
MITY DEEP VEIN THRO
MBOSIS Nov/15/20
20 UNK:U
NK YES Repeating
Pages
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138592
Page 44 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[RIGHT LOWER EXTREMITY DEEP VEIN THROMBOSIS]
4.Start Date Time: Nov/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138593
Page 45 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[FRACTURE]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138594
Page 46 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020511163]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138595
Page 47 of 176
***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: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138596
Page 48 of 176
***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: 10131653 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[ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138597
Page 49 of 176
***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: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138598
Page 50 of 176
***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: 10131653 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: //
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FDA-CBER-2021-5683-0138599
Page 51 of 176
***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: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138600
Page 52 of 176
***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: 10131653 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?
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138601
Page 53 of 176
***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: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138602
Page 54 of 176
***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: 10131653 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?
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138603
Page 55 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138604
Page 56 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138605
Page 57 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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 :Nov/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138606
Page 58 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138607
Page 59 of 176
***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: 10131653 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:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138608
Page 60 of 176
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138609
Page 61 of 176
***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: 10131653 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?
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138610
Page 62 of 176
***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: 10131653 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: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138611
Page 63 of 176
***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: 10131653 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: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138612
Page 64 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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 Feb/18/2021
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138613
Page 65 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/18/2021
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138614
Page 66 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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:
Feb/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS498L]
5.bSample ID [BS498M]
5.cSample ID [BR9VBH]
5.dSample ID [BR9VBJ]
5.eSample ID [BR9VBK]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138615
Page 67 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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:
Feb/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR64FH]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138616
Page 68 of 176
***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: 10131653 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: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138617
Page 69 of 176
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/04/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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 Mar/4/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138618
Page 70 of 176
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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_SELF
3.Sample Collected? YES
Date of Collection:
Mar/4/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA13491]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138619
Page 71 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138620
Page 72 of 176
***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: 10131653 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?
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138621
Page 73 of 176
***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: 10131653 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:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138622
Page 74 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138623
Page 75 of 176
***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: 10131653 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: [ ]
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138624
Page 76 of 176
***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: 10131653 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 Nov/24/2020
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138625
Page 77 of 176
***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: 10131653 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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138626
Page 78 of 176
***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: 10131653 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
Michael
Dever Approved Mar-11-2021 07:27:22 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
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.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138627
Page 79 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-07-2020 14:46:59 (UTC-05:00)
Eastern Time (US & Canada)Matthew
Stephens
(pfe.mstephens)Not Applicable
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138628
Page 80 of 176
***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: 10131653 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
Michael
Dever Approved Mar-11-2021 07:27:22 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
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.
Scott
Salmon N/A Mar-09-2021 10:28:53 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Mar-08-2021 11:37:01 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138629
Page 81 of 176
***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: 10131653 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.
Scott
Salmon N/A Mar-05-2021 12:31:10 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Patricia
Brown Approved Feb-25-2021 14:39:31 (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.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138630
Page 82 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Scott
Salmon N/A Feb-10-2021 15:01:11 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Jan-22-2021 06:49:18 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
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.
Matthew
Stephens N/A Nov-24-2020 15:57:54 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Dever Approved Nov-10-2020 08:27:47 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138631
Page 83 of 176
***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: 10131653 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.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138632
Page 84 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Oct-07-2020
14:46:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-07-2020
14:46:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138633
Page 85 of 176
***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: 10131653 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
Oct-07-2020
14:46:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Oct/7/2020Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138634
Page 86 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Oct-07-2020
14:46:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10131653Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-07-2020
14:46:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/2003Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-07-2020
14:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
(b) (6)
FDA-CBER-2021-5683-0138635
Page 87 of 176
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
HISPANIC OR LA
TINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-07-2020
14:46:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BLACK OR AFRI
CAN AMERICANInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138636
Page 88 of 176
***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: 10131653 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
Oct-07-2020
14:46:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138637
Page 89 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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-07-2020
14:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020
14:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020
14:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138638
Page 90 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Oct-07-2020
14:47:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:ASTHM
A
Start Date: UNK/U
NK/2008
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:47:23
(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
Oct-07-2020
14:47:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ASTHMAInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138639
Page 91 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.a Start Date:
Date Location User Value Reason
Oct-07-2020
14:47:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-07-2020
14:47:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-07-2020
14:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:2
Medic
al Hist
ory Te
rm:ATTENTION
DEFICIT HY
PERACTIVIT
Y DISORDE
RInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138640
Page 92 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Start
Date:UNK/UNK/20
08
Ongoi
ng:YES
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138641
Page 93 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:47:56
(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
Oct-07-2020
14:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ATTENTION DEFI
CIT HYPERACTI
VITY DISORDERInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-07-2020
14:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-07-2020
14:47:56ACV0PFEINFP6000 Matthew
StephensData Entry:
YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138642
Page 94 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens)
1.c
Date Location User Value Reason
Oct-07-2020
14:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:CHARCOT
MARIE TO
OTH
Start Dat
e:UNK/UNK
/2005
Ongoing: YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138643
Page 95 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020
14:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CHARCOT MARI
E TOOTHInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-07-2020
14:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-07-2020
14:48:27ACV0PFEINFP6000 Matthew
StephensData Entry:
YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138644
Page 96 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens)
1.d
Date Location User Value Reason
Oct-07-2020
14:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:OBESIT
Y
Start Date: UNK/U
NK/201
9
Ongoing: YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138645
Page 97 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.d Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020
14:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
OBESITYInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-07-2020
14:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-07-2020
14:48:37ACV0PFEINFP6000 Matthew
StephensData Entry:
YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138646
Page 98 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens)
1.e
Date Location User Value Reason
Feb-10-2021
15:01:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Line/M
H Num
ber:5
Medica
l Histor
y Term:ANKLE
FRACT
URE RI
GHT
Start D
ate:Sep/11/2
020
Ongoin
g:YESNew
Information
Jan-19-2021
16:48:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Monica
Cooper
(pfe.mcooper)Data Entry:
Line/M
H Num
ber:5
Medica
l Histor
y Term:ANKLE
FRACT
URE RI
GHT
Start D
ate:Sep/UN
K/2020
Ongoin
g:YESTranscription
Error
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138647
Page 99 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:48:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:5
Medica
l Histor
y Term:ANKLE
FRACT
URE RI
GHT
Start D
ate:UNK/UN
K/2010
Ongoin
g:YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138648
Page 100 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:48:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-20-2021
22:07:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Jan-19-2021
16:49:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Monica Cooper
(pfe.mcooper)Query 1: Answere
dEDC entry
error corrected
date on MH
item per
source
Dec-31-2020
08:58:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened On review of
the SAE
report for
lower
extemity
DVT, medical
history of Rt
ankle Fx on
11Sep20 was
mentioned, yet
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138649
Page 101 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
it does not
appear in the
CRF. Please
review for
clinical
relevance to
safety event
and update
Med Hx log
CRF if
appropriate.
Oct-07-2020
14:48:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ANKLE FRACTU
RE RIGHTInitial Entry
1.e Start Date:
Date Location User Value Reason
Feb-10-2021
15:01:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sep/11/2020New
Information
Jan-19-2021
16:48:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Monica Cooper
(pfe.mcooper)Data Entry:
Sep/UNK/2020Transcription
Error
Oct-07-2020
14:48:49ACV0PFEINFP6000 Matthew
StephensData Entry:
UNK/UNK/2010Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138650
Page 102 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)(pfe.mstephens)
1.e Ongoing:
Date Location User Value Reason
Oct-07-2020
14:48:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-07-2020
14:49:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umbe
r:6
Medic
al Hist
ory Te
rm:ACHILLES T
ENDON RIGH
T AND LEFT
RELEASE
Start
Date:UNK/UNK/20
11
Ongoi
ng:NO
End Date:
UNK/UNK/
2011Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138651
Page 103 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.f Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:49:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020
14:49:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ACHILLES TEND
ON RIGHT AND L
EFT RELEASEInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-07-2020
14:49:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2011Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-07-2020
14:49:19ACV0PFEINFP6000 Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138652
Page 104 of 176
***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: 10131653 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/2011
1.g
Date Location User Value Reason
Oct-07-2020
14:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/
MH N
umbe
r:7
Medic
al Hist
ory Te
rm:ACHILLES T
ENDON RIGH
T AND LEFT
RELEASE
Start
Date:UNK/UNK/20
13
Ongoi
ng:NO
End Date:
UNK/UNK/
2013Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138653
Page 105 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.g Line/MH Number:
Date Location User Value Reason
Oct-07-2020
14:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020
14:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ACHILLES TEND
ON RIGHT AND L
EFT RELEASEInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-07-2020
14:49:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-07-2020
14:49:35ACV0PFEINFP6000 Matthew
StephensData Entry:
NOInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138654
Page 106 of 176
***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: 10131653 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/2013
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138655
Page 107 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-07-2020
14:49:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138656
Page 108 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
102.7Initial Entry
3. Unit:
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138657
Page 109 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
155.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-07-2020
14:50:01
(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
Oct-13-2020
21:34:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Lingyan Zuo
(pfe.zuol02)Query 1: Closed Response
satisfies query
Oct-09-2020
08:33:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 1: Answere
dCORRECT AS
RECORDED
AS SUBJECT
HAS A
MEDICAL
HISTORY OF
OBESITY
Oct-08-2020
20:47:07ACV0PFEINFP6000 Lingyan Zuo
(pfe.zuol02)Query 1: Opened ClinQuery: v1:
Please can you
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138658
Page 110 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)review the
height/weight
combinations
for this subject
as the derived
BMI is further
out of range
than expected.
Thanks
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
42.7Initial Entry
7.a
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.6
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138659
Page 111 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-07-2020
14:50:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138660
Page 112 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138661
Page 113 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138662
Page 114 of 176
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-07-2020
14:50:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138663
Page 115 of 176
***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: 10131653 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
Oct-07-2020
14:50:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-07-2020
14:50:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
104654Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138664
Page 116 of 176
***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: 10131653 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-07-2020
14:50:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
14:50:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:00:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
14:50:32
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138665
Page 117 of 176
***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: 10131653 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.
Oct-07-2020
14:50:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2K
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:00:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2KHInitial Entry
5.b
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138666
Page 118 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-07-2020
16:00:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2K
JInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020
16:00:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2KJInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020
16:00:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BPC2K
KInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138667
Page 119 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-07-2020
16:00:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BPC2KKInitial Entry
5.d
Date Location User Value Reason
Oct-07-2020
16:00:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BS6ZD
6Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-07-2020
16:00:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BS6ZD6Initial Entry
5.e
Date Location User Value Reason
Oct-07-2020
16:01:02ACV0PFEINFP6000 Matthew
StephensData Entry:
Sample I BS6ZDInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138668
Page 120 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.mstephens) D: 7
5.e Sample ID
Date Location User Value Reason
Oct-07-2020
16:01:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BS6ZD7Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138669
Page 121 of 176
***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: 10131653 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-07-2020
14:50:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
14:50:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:01:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
14:50:42
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138670
Page 122 of 176
***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: 10131653 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.
Oct-07-2020
14:50:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:01:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Sample I
D:BRG2T
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
16:01:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
BRG2TSInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138671
Page 123 of 176
***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: 10131653 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
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138672
Page 124 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/7/2020 12:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138673
Page 125 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020
14:50:55
(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
Oct-07-2020
14:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138674
Page 126 of 176
***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: 10131653 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
Oct-07-2020
14:51:02
(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
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138675
Page 127 of 176
***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: 10131653 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
Oct-27-2020
15:17:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138676
Page 128 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-27-2020
15:17:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020Initial Entry
2.a
Date Location User Value Reason
Oct-27-2020
15:17:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Record Id
entifier::1
Temperat
ure:36.8
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-27-2020
15:17:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
1Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138677
Page 129 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Oct-27-2020
15:17:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-27-2020
15:17:45
(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
Oct-27-2020
15:17:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138678
Page 130 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138679
Page 131 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138680
Page 132 of 176
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-27-2020
15:18:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138681
Page 133 of 176
***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: 10131653 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-27-2020
15:18:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020
15:18:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020
17:15:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-27-2020
15:18:11
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138682
Page 134 of 176
***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: 10131653 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.
Oct-27-2020
15:18:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020
17:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR9TJ
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-27-2020
17:15:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BR9TJRInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138683
Page 135 of 176
***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: 10131653 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
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138684
Page 136 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Oct/27/2020 14:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138685
Page 137 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-27-2020
15:19:09
(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
Oct-27-2020
15:19:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138686
Page 138 of 176
***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: 10131653 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-24-2020
15:57:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Nov/24/2020Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138687
Page 139 of 176
***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: 10131653 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
Nov-24-2020
15:58:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-24-2020
15:58:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-24-2020
17:50:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-24-2020
17:50:18
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138688
Page 140 of 176
***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: 10131653 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.
Nov-24-2020
17:49:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-24-2020
15:58:03
(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.
Nov-24-2020
15:58:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Date of Collectio
n:
Nov/24/2020Initial Entry
5.a
Date Location User Value Reason
Nov-24-2020
17:50:18
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:1BS0JH
DTranscription
Error
(DELETED)
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138689
Page 141 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
Nov-24-2020
17:49:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:1BS0JH
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-24-2020
17:50:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
1BS0JHDTranscription
Error
(DELETED)
Nov-24-2020
17:50:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-24-2020
17:49:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not
6 characters in
length. Please
review and
correct as
appropriate.
Nov-24-2020
17:49:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
1BS0JHDInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138690
Page 142 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b
Date Location User Value Reason
Nov-24-2020
17:50:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BS0JH
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-24-2020
17:50:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BS0JHDInitial Entry
5.c
Date Location User Value Reason
Nov-24-2020
17:50:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BS0JH
FInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138691
Page 143 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Nov-24-2020
17:50:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BS0JHFInitial Entry
5.d
Date Location User Value Reason
Nov-24-2020
17:51:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRHW3
4Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-24-2020
17:51:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRHW34Initial Entry
5.e
Date Location User Value Reason
Nov-24-2020
17:51:34ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I BRHW3Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138692
Page 144 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)D: 5
5.e Sample ID
Date Location User Value Reason
Nov-24-2020
17:51:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRHW35Initial Entry
5.f
Date Location User Value Reason
Nov-24-2020
17:51:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BRHW3
6Initial Entry
5.f Sample ID
Date Location User Value Reason
Nov-24-2020
17:51:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BRHW36Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138693
Page 145 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Form Created
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138694
Page 146 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-23-2021
13:28:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Closed Response
satisfies query
Feb-10-2021
15:02:03
(UTC-05:00)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 3: Answere
dRight ankle
fracture start
date updated
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138695
Page 147 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)Med Hx CRF.
Feb-02-2021
09:56:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opened Clinical On
review of the
SAE report for
DVT, an event
of Rt. ankle Fx
(11Sep20) was
reported, yet it
does not
appear on the
CRF. As event
occurred prior
to visit 3,
please review
for safety and
update AE log
CRF
accordingly.
Jan-06-2021
13:24:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed SAE term has
been updated
to Right lower
extremity
DVT
Dec-27-2020
12:20:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Event is prior
to informed
consent; will
move query to
Med Hx
Dec-27-2020
12:18:42ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL
On review of
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138696
Page 148 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)the SAE report
for DVT, an
event of Right
ankle fracture
before visit 3
has been
mentioned, yet
it does not
appear in the
CRF. Please
review for
safety and
update AE log
CRF
accordingly.
Dec-27-2020
12:17:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL
SAE term is
RIGHT lower
extremity
DVT, and
SAE history
states Rt.
ankle fracture
occurred on
11Sep20.
However,
SAE report
has event term
of LEFT lower
extremity
DVT. Please
review;
harmonize
reporting of
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138697
Page 149 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
DVT side,
with update
where
appropriate
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
RIGHT LOWER
EXTREMITY DE
EP VEIN THRO
MBOSISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Nov/15/2020 UNK:
UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
19:50:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Mar-04-2021
16:00:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 2: Answere
dPER CRC
SAE IS STILL
ONGOING.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138698
Page 150 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-01-2021
00:32:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical Please
review SAE
event of DVT
for end date &
submit to SAE
if end date is
reported
Feb-02-2021
09:48:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-01-2021
15:27:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 1: Answere
dper crc, still
waiting on
records to
update data.
Jan-27-2021
21:34:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical Please
review SAE
event of DVT
for end date &
submit to SAE
if end date is
reported
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138699
Page 151 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-23-2021
13:32:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 5: Close
dResponse
satisfies query
Feb-10-2021
15:03:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 5: Answ
eredUpdated SAE
report sent
8/feb/21.
Feb-02-2021
09:53:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 5: Opene
dClinical The
request for
additional Med
Hx submitted to
SAE report is
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138700
Page 152 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
ONLY for MED
HX CRF
conditions:
Charcot Marie
Tooth (2005),
Rt. ankle
fracture (2010),
& 2 Rt. Achilles
tendon releases
(2011 & 2013);
please submit to
SAE
Feb-02-2021
09:52:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Close
drewording
Feb-02-2021
09:49:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Reiss
ued:OpenedClinical The
request is to
report the Med
Hx CRF
conditions of Rt.
Feb-02-2021
09:48:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Close
dResponse
satisfies query
Feb-01-2021
15:28:02
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 3: Answ
eredper crc still
waiting on
records.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138701
Page 153 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US & Canada)
Feb-01-2021
15:27:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Query 4: Answ
eredper crc still
waiting on
records.
Jan-21-2021
16:04:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 4: Opene
dClinical
Followup -
please submit a
SAE safety
update reporting
the subject's
connective tissue
& past
orthopedic
history, from the
Med History
CRF, as relevant
to this current
fracture/SAE
event.
Jan-20-2021
22:10:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 4: Candi
dateClinical
Followup -
please submit a
SAE safety
update reporting
the subject's
connective tissue
& past
orthopedic
history, from the
Med History
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138702
Page 154 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
CRF, as relevant
to this current
fracture/SAE
event.
Jan-06-2021
13:25:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Close
dQuery closed;
will follow for
SAE update with
the requested
Med Hx updated
info
Jan-02-2021
01:35:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Dec-31-2020
09:01:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 3: Opene
dClinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2020511163]
to document if
COVID testing
was performed
(YES/NO or info
not available)
and if yes, the
date and results.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138703
Page 155 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-28-2020
09:24:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Query 2: Answ
eredCRC WILL
UPDATE.
Dec-27-2020
12:24:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opene
dClinical Please
submit a SAE
safety update
reporting the
subject's
connective tissue
& past
orthopedic
history, from the
Med History
CRF, as relevant
to this current
fracture/SAE
event.
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candi
dateFor AE RIGHT
LOWER
EXTREMITY
DEEP VEIN
THROMBOSIS:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138704
Page 156 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YES
Is this serious
event associat
ed with conge
nital anomaly
or birth defect
?
NO
Did this serio
us event resul
t in death?
NO
Did this serio
us event requi
re or prolong
hospitalizatio
n?
YES
Did this serio
us event resul
t in persistent
or significant
disability/inca
pacity?
NOInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138705
Page 157 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Is this serious
event life thre
atening?
NO
Other medical
ly important s
erious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:
OTHERInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138706
Page 158 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
If Other, specify
:
FRACTURE
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138707
Page 159 of 176
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
RECOVERING/RE
SOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-23-2020
14:10:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-02-2021
01:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020511163Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138708
Page 160 of 176
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Nov-24-2020
15:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Nov/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-24-2020
15:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-24-2020
15:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138709
Page 161 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Feb-22-2021
10:49:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Feb/18/2021Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138710
Page 162 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Feb-22-2021
10:50:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/18/2021Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138711
Page 163 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Feb-19-2021
12:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021
12:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
12:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
12:45:31
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138712
Page 164 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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.
Feb-19-2021
12:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
12:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BS498
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021
12:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BS498LInitial Entry
5.b
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138713
Page 165 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-19-2021
12:45:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BS498
MInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-19-2021
12:45:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BS498MInitial Entry
5.c
Date Location User Value Reason
Feb-19-2021
12:46:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:BR9VB
HInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138714
Page 166 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Feb-19-2021
12:46:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BR9VBHInitial Entry
5.d
Date Location User Value Reason
Feb-19-2021
12:46:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR9VB
JInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-19-2021
12:46:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BR9VBJInitial Entry
5.e
Date Location User Value Reason
Feb-19-2021
12:46:35ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I BR9VBInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138715
Page 167 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)D: K
5.e Sample ID
Date Location User Value Reason
Feb-19-2021
12:46:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BR9VBKInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138716
Page 168 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Feb-19-2021
13:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021
13:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021
13:05:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-19-2021
13:05:22
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138717
Page 169 of 176
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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.
Feb-19-2021
13:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-19-2021
13:05:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample ID
:BR64F
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021
13:05:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
BR64FHInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138718
Page 170 of 176
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/04/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Mar-09-2021
10:29:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/4/2021Changed
Information
Mar-09-2021
10:28:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/3/2021Transcription
Error
Mar-05-2021
12:31:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Mar/4/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-05-2021
12:31:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138719
Page 171 of 176
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 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
Mar-05-2021
12:31:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-05-2021
12:31:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
NASAL_SWAB_SE
LFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021
10:29:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto
Query
Mar-09-2021
10:28:52
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Date of
Collection is
different from
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138720
Page 172 of 176
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)Date of Visit.
Please review
and update as
appropriate,
else clarify.
Mar-05-2021
12:32:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-05-2021
12:31:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-05-2021
12:31:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
YES
Date of Collection
:
Mar/4/2021Initial Entry
5.a
Date Location User Value Reason
Mar-05-2021
12:32:03
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
Sample I
D:AA1349
1Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138721
Page 173 of 176
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Mar/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1013 Site Name: (1013) Clinical Neuroscience Solutions Inc.
Subject No: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
5.a Sample ID
Date Location User Value Reason
Mar-05-2021
12:32:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Scott Salmon
(pfe.ssalmon)Data Entry:
AA13491Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138722
Page 174 of 176
***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: 10131653 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
Nov-24-2020
15:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-07-2020
14:50:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Oct-07-2020
14:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-24-2020
15:58:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/24/2020Initial Entry
Oct-07-2020
14:50:25ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138723
Page 175 of 176
***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: 10131653 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
Oct-07-2020
14:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138724
Page 176 of 176
***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: 10131653 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
Oct-07-2020
15:52:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Matthew
Stephens
(pfe.mstephens)Data Entry:
Click Here to Enabl
eInitial Entry
090177e196ae2f55\Final\Final On: 01-Apr-2021 03:40 (GMT)
FDA-CBER-2021-5683-0138725