Document text
Page 1 of 159
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913819
Page 2 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913820
Page 3 of 159
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10481088]
2.Birth Date: /1996
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913821
Page 4 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913822
Page 5 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913823
Page 6 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913824
Page 7 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913825
Page 8 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [167.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [25.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913826
Page 9 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS Comments
2.Lab Sub-Panel: PREGNANCY Comments
3.Collection Date: Sep/4/2020 Comments
4.Laboratory Name and
Address (Derived)[STUDY SITE] Comments
5.Specimen Type: URINE Comments
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE Comments
Not Done: Comments
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913827
Page 10 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [81142]
3.Randomization Group: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913828
Page 11 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPL2L0]
5.bSample ID [BPL2KZ]
5.cSample ID [BP3LLV]
5.dSample ID [BP3LLW]
5.eSample ID [BP3LLX]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913829
Page 12 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP3LPN]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913830
Page 13 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 10:11
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
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913831
Page 14 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913832
Page 15 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913833
Page 16 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913834
Page 17 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/25/2020
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:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913835
Page 18 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BP3LVS]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913836
Page 19 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 08:43
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
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913837
Page 20 of 159
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913838
Page 21 of 159
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913839
Page 22 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913840
Page 23 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913841
Page 24 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913842
Page 25 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913843
Page 26 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913844
Page 27 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913845
Page 28 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913846
Page 29 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913847
Page 30 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913848
Page 31 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913849
Page 32 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913850
Page 33 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913851
Page 34 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913852
Page 35 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913853
Page 36 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913854
Page 37 of 159
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913855
Page 38 of 159
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913856
Page 39 of 159
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913857
Page 40 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913858
Page 41 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913859
Page 42 of 159
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Exposure durin
g pregnancy Sep/20/2020
UNK:UNK YES Repeating
Pages
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913860
Page 43 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Exposure during pregnancy]
4.Start Date Time: Sep/20/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913861
Page 44 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).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:
[failed contraception]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913862
Page 45 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913863
Page 46 of 159
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedication
ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication E
rrors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913864
Page 47 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913865
Page 48 of 159
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913866
Page 49 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913867
Page 50 of 159
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913868
Page 51 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913869
Page 52 of 159
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913870
Page 53 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913871
Page 54 of 159
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913872
Page 55 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913873
Page 56 of 159
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913874
Page 57 of 159
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913875
Page 58 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913876
Page 59 of 159
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay
of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for
at least the protocol
specified observation period
after investigational product
administration?
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913877
Page 60 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913878
Page 61 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913879
Page 62 of 159
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913880
Page 63 of 159
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913881
Page 64 of 159
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913882
Page 65 of 159
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913883
Page 66 of 159
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913884
Page 67 of 159
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913885
Page 68 of 159
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/16/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913886
Page 69 of 159
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913887
Page 70 of 159
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913888
Page 71 of 159
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Subject Status
1.Subject Status ENROLLED/RANDOMIZED
2.Subject Status Date Sep/4/2020
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913889
Page 72 of 159
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913890
Page 73 of 159
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913891
Page 74 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-13-2020 12:05:35 (UTC-07:00)
Mountain Time (US & Canada)not a screen fail
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913892
Page 75 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-13-2020 12:07:21 (UTC-07:00)
Mountain Time (US & Canada)None
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913893
Page 76 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
FormSep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom
with or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913894
Page 77 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
1Sep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913895
Page 78 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
2Sep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913896
Page 79 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
3Sep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913897
Page 80 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
4Sep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913898
Page 81 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
5Sep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913899
Page 82 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
6.aSep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913900
Page 83 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
6.aSep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913901
Page 84 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-25-2020 10:24:56 (UTC-07:00)
Mountain Time (US & Canada)
6.aSep-13-2020 12:15:29 (UTC-07:00)
Mountain Time (US & Canada)male condom or female condom with
or without spermicide
Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913902
Page 85 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-16-2020 12:43:35 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913903
Page 86 of 159
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-12-2021 15:37:57 (UTC-07:00)
Mountain Time (US & Canada)not done; subject is pregnant
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913904
Page 87 of 159
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-17-2021 17:15:05 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Abram
Burgher Approved Nov-16-2020 17:39:38 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AbramBurgher, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Nov-12-2020 16:11:40 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913905
Page 88 of 159
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Abram
Burgher Approved Nov-06-2020 09:45:40 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AbramBurgher, 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.
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913906
Page 89 of 159
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-13-2020
12:00:25
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-13-2020
12:00:25
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913907
Page 90 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-24-2020
18:59:03
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/4/2020Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913908
Page 91 of 159
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-13-2020
12:00:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10481088Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-13-2020
12:00:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1996Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-13-2020
12:04:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913909
Page 92 of 159
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-13-2020
12:04:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-13-2020
12:04:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913910
Page 93 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-13-2020
12:05:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913911
Page 94 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-13-2020
12:06:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-13-2020
12:06:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-13-2020
12:06:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913912
Page 95 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
167.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913913
Page 96 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.4Initial Entry
7.a
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.0Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913914
Page 97 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913915
Page 98 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-13-2020
12:09:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913916
Page 99 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
Sep-25-2020
10:24:56ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913917
Page 100 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-07:00)
Mountain Time
(US & Canada)
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-28-2020
18:53:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913918
Page 101 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Sep-22-2020
18:52:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedClinQuery:
Please follow
4.11.3.
Deletion of an
Item Level or
Form Level
Comment to
delete the
form level
comment.
please add in
result.
Sep-21-2020
17:25:26
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered comment
should be
removed. Test
was run and
was negative.
Sep-14-2020
19:24:09
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Please can you
confirm why a
pregnancy test
was not done
for this
subject? There
is nothing in
her medical
history to
indicate she is
not a woman
of child
bearing
potential.
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913919
Page 102 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Thanks
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913920
Page 103 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mountain Time
(US & Canada)
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Not A
pplica
ble
Result:: NEGA
TIVE
Not Done::Initial Entry
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-De
fined Identi
fier:Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913921
Page 104 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Test:: Not A
pplica
ble
Result::
Not Done::
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913922
Page 105 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020
10:25:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-13-2020
12:15:29
(UTC-07:00)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913923
Page 106 of 159
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mountain Time
(US & Canada)
6.a Not Done:
Date Location User Value Reason
Sep-25-2020
10:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Sep-13-2020
12:15:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913924
Page 107 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-13-2020
12:16:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-13-2020
12:16:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
81142Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913925
Page 108 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020
12:24:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020
12:24:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020
12:24:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-19-2020
12:24:05
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913926
Page 109 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) are entered.
Please review
and correct as
appropriate.
Sep-19-2020
12:24:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020
12:24:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPL2L
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020
12:24:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPL2L0Initial Entry
5.b
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913927
Page 110 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-19-2020
12:24:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPL2K
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-19-2020
12:24:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPL2KZInitial Entry
5.c
Date Location User Value Reason
Sep-19-2020
12:24:46
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3LL
VInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-19-2020
12:24:46
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LLVInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913928
Page 111 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Sep-19-2020
12:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP3LL
WInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-19-2020
12:24:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LLWInitial Entry
5.e
Date Location User Value Reason
Sep-19-2020
12:25:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP3LL
XInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913929
Page 112 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e Sample ID
Date Location User Value Reason
Sep-19-2020
12:25:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LLXInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913930
Page 113 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020
10:19:01
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020
10:19:01
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020
10:19:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-19-2020
10:19:01
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913931
Page 114 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) are entered.
Please review
and correct as
appropriate.
Sep-19-2020
10:19:01
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020
10:19:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3LP
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020
10:19:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LPNInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913932
Page 115 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913933
Page 116 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 10:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913934
Page 117 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-13-2020
12:24:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913935
Page 118 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-19-2020
12:23:51
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913936
Page 119 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
10:25:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913937
Page 120 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
10:25:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020
10:25:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.8
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
10:25:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913938
Page 121 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature:
Date Location User Value Reason
Sep-25-2020
10:25:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020
10:25:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-25-2020
10:25:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913939
Page 122 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913940
Page 123 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogona
dotropin Be
ta_PX113
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913941
Page 124 of 159
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020
10:26:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913942
Page 125 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020
16:33:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020
16:33:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020
16:33:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-28-2020
16:33:28
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913943
Page 126 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) are entered.
Please review
and correct as
appropriate.
Sep-28-2020
16:33:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020
16:33:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP3LV
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-28-2020
16:33:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LVSInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913944
Page 127 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913945
Page 128 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 08:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913946
Page 129 of 159
***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: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-25-2020
10:26:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913947
Page 130 of 159
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-12-2021
15:57:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021
15:57:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription
Error
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913948
Page 131 of 159
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
15:57:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Mar-12-2021
15:41:57
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is
PREGNANCY
but "Specify
Status" is
Provided.
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-12-2021
15:41:57
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913949
Page 132 of 159
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
subject is pregnant;
not eligible for cros
sover meets ex #11
site to follow for sa
fetyInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913950
Page 133 of 159
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913951
Page 134 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain 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
Nov-16-2020
14:14:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-16-2020
12:42:06
(UTC-07:00)ACV0PFEINFP6000 Data Entry:
Exposure during
pregnancyChanged
Information
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913952
Page 135 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mountain Time
(US & Canada)
Nov-16-2020
12:18:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Nov-16-2020
12:17:59
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged
Information
Nov-16-2020
12:17:59
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure during
pregnancy UPDA
TEDChanged
Information
Nov-16-2020
12:13:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answere
dmode of
contraception
WAS
CONFIRMED
MALE
CONDOM. SAE
FORM
UBDATED.
Nov-15-2020
14:54:28
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL -
please report the
mode of
contraception
being used by
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913953
Page 136 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
subject & partner
as a SAE update
Nov-14-2020
09:30:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
The term was
reported as
Pregnancy, Per 3
Nov EDP
guidance (study
communication),
event term
should be
recorded as
Exposure during
pregnancy.
Please confirm
and update
accordingly.
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
pregnancyInitial Entry
4. Start Date Time:
Date Location User ValueReason
Nov-16-2020
14:32:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913954
Page 137 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-16-2020
12:23:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dChanged Information
Nov-16-2020
12:23:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Sep/2
0/202
0 UN
K:UN
KChanged Information
Nov-15-2020
21:28:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2020451090,onset
date was recorded as '04Oct2020'
in AE CRF however,per the CRF
CG v10 8.50.2.5 In the absence
of ultrasound, the data from the
last menstrual period (LMP)
should be used to estimate date
of conception for this case
20Sep2020
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/4/
2020
UNK:
UNKInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913955
Page 138 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021
15:56:51
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value
is correct
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up
form is
completed and
this Adverse
Event is still
ongoing.
Please review
and update as
appropriate.
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020
14:14:48
(UTC-07:00)
Mountain TimeACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913956
Page 139 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Nov-16-2020
12:43:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Nov-16-2020
12:43:17
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dUPDATED
Nov-16-2020
12:43:17
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry: UPDATED
Nov-14-2020
23:37:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Toxicity grade is
not expected for
pregnancy
related adverse
events, hence
please remove
the toxicity and
add item level
comment as
NOT
APPLICABLE.
Nov-12-2020
16:11:40
(UTC-07:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0913957
Page 140 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mountain Time
(US & Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-16-2020
14:34:47
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-16-2020
12:46:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Delete
dClose Auto Query
Nov-16-2020
12:46:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answe
redChanged
Information
Nov-16-2020
12:46:15
(UTC-07:00)ACV0PFEINFP6000 Data Entry:
NOChanged
Information
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913958
Page 141 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mountain Time
(US & Canada)
Nov-16-2020
12:42:06
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candid
ateFor AE Exposure
during pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-16-2020
12:17:59
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candid
ateFor AE Exposure
during pregnancy
UPDATED :
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-15-2020
04:09:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opene
dSAE RECON:
AER#2020451090,
Pregnancy event
was appropriately
reported to safety;
however,
seriousness criteria
is met there is an
abnormal
pregnancy
outcome/protocol
section 8.3.5.1.
Please update
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913959
Page 142 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
seriousness criteria
accordingly.
Nov-15-2020
04:06:44
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed reported in SDB
Nov-14-2020
09:23:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dSAE
RECON:Pregnacny
(onset date:
04Oct2020) was
reported in AE
CRF while missing
in Safety database.
Please confirm if
the event was
reported to Pfizer
Safety.
Nov-14-2020
09:21:34
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed missing in SDB
Nov-14-2020
07:03:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissu
ed:OpenedDM: Please
provide SAE
number when data
is available. Thank
you.
Nov-13-2020
14:06:44ACV0PFEINFP6000 Query 1: Answe
redSAE NUMBER IS
NOT YET
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913960
Page 143 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-07:00)
Mountain Time
(US & Canada)KNOWN
Nov-13-2020
00:28:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
dFor AE pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candid
ateFor AE pregnancy:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious
event associate
d with congeni
tal anomaly or
birth defect?
NO
Did this seriou
s event result i
n death?
NOInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913961
Page 144 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Did this seriou
s event require
or prolong hos
pitalization?
NO
Did this seriou
s event result i
n persistent or
significant disa
bility/incapacit
y?
NO
Is this serious
event life threa
tening?
NO
Other medicall
y important ser
ious event
YES
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
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913962
Page 145 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-16-2020
15:08:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Nov-16-2020
15:07:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New
Information
Nov-16-2020
15:07:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due t
o:
OTHER
If Other, specif
y:
failed contracNew
Information
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913963
Page 146 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eption
Nov-16-2020
14:38:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Is this
event related to
study treatment
is NOT
RELATED
however "If
Not Related to
study
treatment(s),
this event is
due to" is
blank. Please
complete this
field. thanks
Nov-16-2020
14:38:29
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed re-query
Nov-16-2020
14:37:59
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE Recon: Is
this event
related to study
treatment is
NOT
RELATED
however "If
Not Related to
study
treatment(s),
this event is
due to" is
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913964
Page 147 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
blank. Please
complete this
field. thanks
Nov-16-2020
14:15:44
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-16-2020
12:28:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Nov-16-2020
12:28:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDTranscription
Error
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913965
Page 148 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020
22:24:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Is this event
related to
study
treatment" is
missing.
Kindly review
and update.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913966
Page 149 of 159
***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, Answered Queries, Frozen,
Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED
/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-12-2020
16:11:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913967
Page 150 of 159
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
15:57:39
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
ClosedClose Auto Query
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
OpenedDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Feb-17-2021
17:15:05
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data Entr
y:
Feb/16/20
21Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913968
Page 151 of 159
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-12-2021
07:42:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed data updated
Mar-11-2021
16:56:44
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription
Error
Mar-11-2021
16:56:44
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to
have received o
nly placebo at V
accination 1/2Transcription
Error
Mar-11-2021
12:37:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Rivkah Rosen Query 2: Reissued:
OpenedDM: Form has
been unfrozen.
Please update
the data per
prior query.
Thank you.
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0913969
Page 152 of 159
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-11-2021
09:39:05
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject
received active
vaccine and not
placebo. Data
was entered in
error. Please
unfreeze so we
can enter the
correct data.
Mar-10-2021
14:21:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Further
Vaccination
Confirmation
has been
completed;
however, EOT
(DISP TRT for
Vaccination 1/2)
has not been
completed.
Please refer to
CRF
Completion
Requirements
Section 8.66,
FAQ #2 and
update
accordingly.
Feb-17-2021
17:15:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913970
Page 153 of 159
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-17-2021
17:15:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-17-2021
17:15:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible per loca
l/national recom
mendations and
confirmed to ha
ve received only
placebo at Vacci
nation 1/2Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913971
Page 154 of 159
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-17-2021
17:15:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-17-2021
17:15:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913972
Page 155 of 159
***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, Answered Queries, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User ValueReason
Mar-12-2021
15:57:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data
Entry
:
ENRO
LLED
/RAN
DOMI
ZEDTranscription Error
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data
Entry
:
DISC
ONTI
NUE
DInitial Entry
Mar-12-2021
15:38:29
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
3: Ans
weredChanged data per query
Mar-12-2021
15:38:15
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredChanged data per query
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913973
Page 156 of 159
***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, Answered Queries, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021
06:24:51
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Hayley Wyper Query
3: Ope
nedCLINQUERY: V3 has not been
reported yet timepoint has
passed - please clarify reason for
lack of V3 to determine
date/status for end of first
treatment phase (vax1/vax2/V3).
First EOT page to be updated
with this status
Mar-02-2021
00:08:42
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
2: Ope
nedDM: Visit 3 is overdue based on
expected visit window. Please
enter data or, if visit will never
occur, mark Date of Visit as ‘Not
Done’ with form level comment.
If subject is no longer in the trial,
complete the Disposition FUP
form.
Mar-02-2021
00:08:26
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedQuery raised for the same in
SUBSTAT form #1
Feb-22-2021
12:34:47
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query
1: Ope
nedVisit
“V3_MONTH1_POSTVAX2_L”
was expected to occur on
30-OCT-2020. Please enter data
or confirm reason why visit has
not yet occurred. If subject is no
longer in the trial, please
complete the Disposition Follow
Up form.
Sep-13-2020
12:16:22ACV0PFEINFP6000 auto calc
(autocalc)Data
EntryInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0913974
Page 157 of 159
***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, Answered Queries, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-07:00)
Mountain
Time (US &
Canada):
ENRO
LLED
/RAN
DOMI
ZED
Sep-13-2020
12:06:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data
Entry
:
SCRE
ENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-12-2021
15:57:56
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Transcription
Error
Mar-12-2021
15:57:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Transcription
Error
Mar-12-2021
15:41:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
Sep-13-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913975
Page 158 of 159
***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, Answered Queries, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12:16:22
(UTC-07:00)
Mountain Time
(US & Canada)(autocalc) Sep/4/2020
Sep-13-2020
12:06:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913976
Page 159 of 159
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481088 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020
09:17:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30a6\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913977