Document text
Page 1 of 302
***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: 10481032 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
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913517
Page 2 of 302
***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: 10481032 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
Aug/25/2020
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913518
Page 3 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10481032]
2.Birth Date: /1974
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913519
Page 4 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913520
Page 5 of 302
***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: 10481032 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
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913521
Page 6 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913522
Page 7 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastritis]
Start Date: May/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hiatal hernia]
Start Date: May/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[post menopausal]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[muscle spasms]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913523
Page 8 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[degenerative disc disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bipolar disorder]
Start Date: UNK/UNK/2001
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/2010
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[difficulty with sleeping]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913524
Page 9 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tardive Diskinesia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[akathisia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913525
Page 10 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [30.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913526
Page 11 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913527
Page 12 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [64823]
3.Randomization Group: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913528
Page 13 of 302
***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: 10481032 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:
Aug/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 [BP3LC2]
5.bSample ID [BP3LC1]
5.cSample ID [BP3LC0]
5.dSample ID [BPL2RB]
5.eSample ID [BPL2R9]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913529
Page 14 of 302
***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: 10481032 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:
Aug/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 [BP3LC3]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913530
Page 15 of 302
***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: 10481032 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: Aug/25/2020 15:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913531
Page 16 of 302
***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: 10481032 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
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913532
Page 17 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913533
Page 18 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913534
Page 19 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913535
Page 20 of 302
***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: 10481032 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/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3LT0]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913536
Page 21 of 302
***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: 10481032 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/15/2020 12:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913537
Page 22 of 302
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913538
Page 23 of 302
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVSHR]
5.bSample ID [BS696H]
5.cSample ID [BS696J]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913539
Page 24 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913540
Page 25 of 302
***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: 10481032 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 [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913541
Page 26 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913542
Page 27 of 302
***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: 10481032 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 [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913543
Page 28 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913544
Page 29 of 302
***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: 10481032 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 [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913545
Page 30 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913546
Page 31 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/7/2020
2.Date of First Symptom Started: Dec/5/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/17/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913547
Page 32 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [FATIGUE]
5.bSymptoms - Other Text: [HEADACHE]
5.cSymptoms - Other Text: [NASAL CONGESTION]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913548
Page 33 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913549
Page 34 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913550
Page 35 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[pfe] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913551
Page 36 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10481032 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:
Dec/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ85W]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913552
Page 37 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913553
Page 38 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913554
Page 39 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913555
Page 40 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[upper respiratory infection]
Date of Diagnosis:
Dec/5/2020
3.Toxicity Grade: 1
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913556
Page 41 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913557
Page 42 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913558
Page 43 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913559
Page 44 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913560
Page 45 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913561
Page 46 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913562
Page 47 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Dec/7/2020 Record Identifier: Systolic: Diastolic:
1 121 77 Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913563
Page 48 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [121]
Diastolic: [77]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [83]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913564
Page 49 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913565
Page 50 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913566
Page 51 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913567
Page 52 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913568
Page 53 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913569
Page 54 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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.Start Date: //
6.Ongoing?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913570
Page 55 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913571
Page 56 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913572
Page 57 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913573
Page 58 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/27/2021
2.Date of First Symptom Started: Jan/27/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913574
Page 59 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.aSymptoms - Other Text: [sore throat ]
5.bSymptoms - Other Text: [tightening in the chest]
5.cSymptoms - Other Text: [Headache]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913575
Page 60 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Jan/27/202
1 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913576
Page 61 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/27/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [unknown]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913577
Page 62 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10481032 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_SELF
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV58599]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913578
Page 63 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10481032 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[selfswab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913579
Page 64 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913580
Page 65 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913581
Page 66 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913582
Page 67 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913583
Page 68 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913584
Page 69 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913585
Page 70 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913586
Page 71 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913587
Page 72 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913588
Page 73 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913589
Page 74 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913590
Page 75 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913591
Page 76 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913592
Page 77 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913593
Page 78 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913594
Page 79 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913595
Page 80 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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.Start Date: //
6.Ongoing?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913596
Page 81 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913597
Page 82 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/27/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913598
Page 83 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/25/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913599
Page 84 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/25/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10481032 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:
Jan/25/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVSMZ]
5.bSample ID [BS69CK]
5.cSample ID [BS69CJ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913600
Page 85 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/25/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913601
Page 86 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Feb/25/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 10481032 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:
Feb/25/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVSBW]
5.bSample ID [ ]
5.cSample ID [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913602
Page 87 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913603
Page 88 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913604
Page 89 of 302
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913605
Page 90 of 302
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913606
Page 91 of 302
***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: 10481032 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:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913607
Page 92 of 302
***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: 10481032 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 [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913608
Page 93 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 PAIN AT INJECTION
SITE Aug/26/2020 U
NK:UNK NO
End Date Time:
Aug/30/2020 UNK:
UNK
Repeating
Pages
2. ADVERSE
EVENT 2 Fatigue Sep/16/2020 0
9:00 NO
End Date Time:
Sep/17/2020 18:00
Repeating
Pages
3. DELETED ADVERSE
EVENT 3 UPPER RESPIRATOR
Y INFECTION Dec/5/2020 U
NK:UNK NO
End Date Time:
Dec/17/2020 UNK:
UNK
Repeating
Pages
4. ADVERSE
EVENT 4 Worsening of degenerat
ive disc disease Jan/11/2021 U
NK:UNK YES Repeating
Pages
5. ADVERSE
EVENT 5 Worsening of gastritis Feb/14/2021 0
8:00 NO
End Date Time:
Feb/17/2021 UNK:
UNK
Repeating
Pages
6. ADVERSE
EVENT 6 Worsening of gastropar
esis Feb/14/2021 0
8:00 NO
End Date Time:
Feb/17/2021 UNK:
UNK
Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913609
Page 94 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10481032 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)[PAIN AT INJECTION SITE]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913610
Page 95 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913611
Page 96 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Sep/16/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/17/2020 18:00
6.Toxicity Grade: 2
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913612
Page 97 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913613
Page 98 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Not Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[UPPER RESPIRATORY INFECTION ]
4.Start Date Time: Dec/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 UNK:UNK
6.Toxicity Grade: 2
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:
[VIRUS]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913614
Page 99 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Not Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913615
Page 100 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of degenerative disc disease]
4.Start Date Time: Jan/11/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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:
[Natural progression of the disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913616
Page 101 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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[ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913617
Page 102 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of gastritis]
4.Start Date Time: Feb/14/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/17/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913618
Page 103 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Progression of disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021218841]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913619
Page 104 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of gastroparesis]
4.Start Date Time: Feb/14/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/17/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913620
Page 105 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified, Frozen
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Progression of disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021218841]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913621
Page 106 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913622
Page 107 of 302
***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: 10481032 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[ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913623
Page 108 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart Da
teForm Instanc
e
1.1 VACCINATIONS NO Influenza vacci
ne Oct/27/2
020 Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913624
Page 109 of 302
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Influenza vaccine]
5.Date: Oct/27/2020
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913625
Page 110 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913626
Page 111 of 302
***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: 10481032 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?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913627
Page 112 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913628
Page 113 of 302
***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: 10481032 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?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913629
Page 114 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913630
Page 115 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913631
Page 116 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913632
Page 117 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10481032 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:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913633
Page 118 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10481032 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:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913634
Page 119 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10481032 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?
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913635
Page 120 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913636
Page 121 of 302
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913637
Page 122 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913638
Page 123 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913639
Page 124 of 302
***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: 10481032 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 [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913640
Page 125 of 302
***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: 10481032 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 [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913641
Page 126 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913642
Page 127 of 302
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 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
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913643
Page 128 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913644
Page 129 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913645
Page 130 of 302
***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: 10481032 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: [ ]
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913646
Page 131 of 302
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913647
Page 132 of 302
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10481032 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
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913648
Page 133 of 302
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10481032 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
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913649
Page 134 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-26-2020 12:50:02 (UTC-07:00) Mountain
Time (US & Canada)not a SF
Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913650
Page 135 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-26-2020 13:02:00 (UTC-07:00) Mountain
Time (US & Canada)not done as subject is post menopausal
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913651
Page 136 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-10-2020 13:53:33 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913652
Page 137 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 14:26:35 (UTC-07:00) Mountain
Time (US & Canada)Not done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913653
Page 138 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 14:26:35 (UTC-07:00) Mountain
Time (US & Canada)Not done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913654
Page 139 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 14:26:35 (UTC-07:00) Mountain
Time (US & Canada)Not done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913655
Page 140 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913656
Page 141 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913657
Page 142 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913658
Page 143 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913659
Page 144 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913660
Page 145 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913661
Page 146 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913662
Page 147 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913663
Page 148 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 14:07:21 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913664
Page 149 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913665
Page 150 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913666
Page 151 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913667
Page 152 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913668
Page 153 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913669
Page 154 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913670
Page 155 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913671
Page 156 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913672
Page 157 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913673
Page 158 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Jan-19-2021 13:43:39 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913674
Page 159 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-19-2021 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)
FormDec-08-2020 08:46:35 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913675
Page 160 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-19-2021 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)
1Dec-08-2020 08:46:35 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913676
Page 161 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-19-2021 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)
2Dec-08-2020 08:46:35 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913677
Page 162 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-19-2021 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)
3Dec-08-2020 08:46:35 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913678
Page 163 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-19-2021 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)
4Dec-08-2020 08:46:35 (UTC-07:00) Mountain
Time (US & Canada)Not Done
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913679
Page 164 of 302
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Jan-25-2021 18:19:39 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Abram Burgher Approved Jan-20-2021 15:51:40 (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.
N/A Jan-19-2021 13:42:22 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Abram Burgher Approved Dec-11-2020 11:24:36 (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.
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913680
Page 165 of 302
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Dec-08-2020 07:53:25 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Abram Burgher Approved Oct-21-2020 20:45:02 (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.
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913681
Page 166 of 302
***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: 10481032 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
Aug-26-2020 12:48:57
(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
Aug-26-2020 12:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913682
Page 167 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 12:49:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913683
Page 168 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 12:48:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10481032Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 12:48:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 12:49:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 12:49:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 12:49:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913684
Page 169 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 12:49:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913685
Page 170 of 302
***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: 10481032 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
Aug-26-2020 12:50:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 12:50:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 12:50:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913686
Page 171 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020 12:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:gastritis
Start Date: May/UNK/20
20
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
gastritisInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020 12:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020 12:50:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae30a5\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-2021-5683-0913687
Page 172 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-26-2020 12:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Hiatal hernia
Start Date: May/UNK/20
20
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Hiatal herniaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020 12:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020 12:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-26-2020 12:52:56
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae30a5\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-2021-5683-0913688
Page 173 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Medical History T
erm:post menopau
sal
Start Date: UNK/UNK/2
018
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:52:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:52:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
post menopausalInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-26-2020 12:52:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020 12:52:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-26-2020 12:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:muscle spasm
sInitial Entry
090177e196ae30a5\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-2021-5683-0913689
Page 174 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
015
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
muscle spasmsInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-26-2020 12:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-26-2020 12:53:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-26-2020 12:53:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:degenerative disc
disease
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae30a5\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-2021-5683-0913690
Page 175 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:53:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:53:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
degenerative disc diseaseInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-26-2020 12:53:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-26-2020 12:53:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-26-2020 12:54:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:bipolar disord
er
Start Date: UNK/UNK/2
001
Ongoing: YESInitial Entry
090177e196ae30a5\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-2021-5683-0913691
Page 176 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:54:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:54:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
bipolar disorderInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-26-2020 12:54:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-26-2020 12:54:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-26-2020 12:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History T
erm:hypothyroidis
m
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae30a5\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-2021-5683-0913692
Page 177 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-26-2020 12:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-26-2020 12:54:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-26-2020 12:54:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History T
erm:sleep apnea
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae30a5\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-2021-5683-0913693
Page 178 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:54:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:54:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sleep apneaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-26-2020 12:54:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-26-2020 12:54:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-26-2020 12:55:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:difficulty with sl
eeping
Start Date: UNK/UNK/201
3
Ongoing: YESInitial Entry
090177e196ae30a5\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-2021-5683-0913694
Page 179 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:55:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:55:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
difficulty with sleepingInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-26-2020 12:55:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-26-2020 12:55:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-26-2020 12:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:Tardive Diskin
esia
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae30a5\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-2021-5683-0913695
Page 180 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tardive DiskinesiaInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-26-2020 12:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-26-2020 12:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a5\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-2021-5683-0913696
Page 181 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Aug-26-2020 12:59:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:akathisia
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:59:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:59:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
akathisiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-26-2020 12:59:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-26-2020 12:59:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
090177e196ae30a5\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-2021-5683-0913697
Page 182 of 302
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-26-2020 12:59:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:obesity
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Aug-26-2020 12:59:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-26-2020 12:59:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
obesityInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-26-2020 12:59:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-26-2020 12:59:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a5\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-2021-5683-0913698
Page 183 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) MountainACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
090177e196ae30a5\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-2021-5683-0913699
Page 184 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 99.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 00:22:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site
confirmation
Aug-26-2020 13:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 99.7 F
is outside of Normal
Range 97 - 99.5 F.
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 13:01:39 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913700
Page 185 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-07:00) Mountain
Time (US & Canada)F
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 13:01:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913701
Page 186 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
3. Collection Date:
Date Location User Value Reason
Sep-10-2020 13:53:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-26-2020 13:01:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 13:01:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020 13:01:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-26-2020 13:01:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae30a5\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-2021-5683-0913702
Page 187 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 13:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 13:02:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
64823Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913703
Page 188 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 08:51:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 08:51:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 08:51:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 08:51:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 08:51:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 08:51:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3LC2Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913704
Page 189 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 08:51:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LC2Initial Entry
5.b
Date Location User Value Reason
Aug-28-2020 08:52:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3LC1Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 08:52:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LC1Initial Entry
5.c
Date Location User Value Reason
Aug-28-2020 08:52:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3LC0Transcription Error
Aug-28-2020 08:52:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3LC0TInitial Entry
090177e196ae30a5\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-2021-5683-0913705
Page 190 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 08:52:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 08:52:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LC0Transcription Error
Aug-28-2020 08:52:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Aug-28-2020 08:52:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LC0TInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 08:53:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL2RBInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 08:53:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL2RBInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020 08:53:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL2R9Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0913706
Page 191 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 08:53:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL2R9Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0913707
Page 192 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 08:54:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 08:54:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 08:54:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3LC3Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0913708
Page 193 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 08:54:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LC3Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0913709
Page 194 of 302
***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: 10481032 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
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 15:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913710
Page 195 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-26-2020 13:03:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913711
Page 196 of 302
***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: 10481032 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
Aug-26-2020 13:03:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913712
Page 197 of 302
***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: 10481032 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-15-2020 14:06:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913713
Page 198 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 14:07:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020 14:07:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 98.2
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 14:07:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-15-2020 14:07:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020 14:07:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913714
Page 199 of 302
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020 14:07:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913715
Page 200 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020 14:07:21
(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-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-15-2020 14:07:21 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913716
Page 201 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-07:00) Mountain
Time (US & Canada)Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cable
6.a Sponsor ID:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-15-2020 14:07:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913717
Page 202 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 12:59:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 12:59:11
(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-15-2020 12:59:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 12:59:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-15-2020 12:59:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 12:59:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP3LT0Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913718
Page 203 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 12:59:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP3LT0Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913719
Page 204 of 302
***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: 10481032 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-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 12:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 14:26:01
(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-15-2020 14:26:01
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913720
Page 205 of 302
***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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-15-2020 14:26:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913721
Page 206 of 302
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 12:22:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913722
Page 207 of 302
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 15:46:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 15:46:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 15:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 15:46:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 15:46:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 15:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVSHRInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913723
Page 208 of 302
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 15:46:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVSHRInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 15:47:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS696HInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 15:47:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS696HInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020 15:47:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS696JInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 15:47:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS696JInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913724
Page 209 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 22:15:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Jan-19-2021 13:43:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Changed data per
query
Dec-09-2020 09:59:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Kindly review
and complete
‘Microbiology
Specimen Illness
Details form' at this
visit. Thank you.
Dec-08-2020 07:57:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-08-2020 07:53:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-08-2020 07:53:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
090177e196ae30a5\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-2021-5683-0913725
Page 210 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-08-2020 07:53:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-08-2020 07:53:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913726
Page 211 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/7/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-01-2021 09:48:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-29-2021 11:26:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Jan-29-2021 06:22:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY:
UPPER
RESPIRATORY
INFECTION is
reported on AE CRF
from 05DEC20
which overlaps with
COVID ILL visit
symptom date. Was
diagnosis
made?Enter
diagnosis of event if
available on ILL
POTEN CRF even if
diagnosis is not
COVID-
19/respiratory
related.
Jan-28-2021 09:24:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate CLINQUERY:
UPPER
RESPIRATORY
INFECTION is
reported on AE CRF
from 05DEC20
090177e196ae30a5\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) (4),
(b) (6)
FDA-CBER-2021-5683-0913727
Page 212 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
which overlaps with
COVID ILL visit
symptom date. Was
diagnosis
made?Enter
diagnosis of event if
available on ILL
POTEN CRF even if
diagnosis is not
COVID-
19/respiratory
related.
Jan-28-2021 09:24:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-27-2021 14:06:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
UPPER
RESPIRATORY
INFECTION is
reported on AE CRF
from 05DEC20
which overlaps with
COVID ILL visit
symptom date. Was
diagnosis
made?Enter
diagnosis of event if
available on ILL
POTEN CRF even if
diagnosis is not
COVID-
19/respiratory
related.
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/5/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-11-2021 23:16:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae30a5\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-2021-5683-0913728
Page 213 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-11-2021 15:04:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-11-2021 15:04:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolv
ed:
Dec/17/2020Changed
Information
Feb-11-2021 15:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Last Symptom
Resolved date is a
future date
compared to when
it was entered.
Please correct.
Feb-11-2021 15:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-11-2021 15:03:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolv
ed:
Dec/17/2021New Information
Feb-01-2021 00:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Next visit
should be entered
only if all the
symptoms at this
visit resolved. If
resolved, please
review and update
the date of last
symptom resolved
as appropriate. If
not, please move
details from next
visit into this visit.
Thank you.
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a5\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-2021-5683-0913729
Page 214 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.a
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREA
SED COUGH
Symptom
Present:YESInitial Entry
090177e196ae30a5\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-2021-5683-0913730
Page 215 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.b Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196ae30a5\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-2021-5683-0913731
Page 216 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30a5\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913732
Page 217 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:YESInitial Entry
090177e196ae30a5\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-2021-5683-0913733
Page 218 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) MountainACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a5\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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913734
Page 219 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Symptoms: VOMITIN
G
Symptom Present
:NO
4.i Symptoms:
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-08-2020 07:55:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-08-2020 07:55:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: FATIGUEInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-08-2020 07:55:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
5.b
Date Location User Value Reason
Dec-08-2020 07:56:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Othe
r:HEADACH
EInitial Entry
090177e196ae30a5\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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913735
Page 220 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-08-2020 07:56:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
5.c
Date Location User Value Reason
Dec-08-2020 07:57:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms -
Other:NASAL CONG
ESTIONInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-08-2020 07:57:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASAL CONGESTIONInitial Entry
090177e196ae30a5\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-2021-5683-0913736
Page 221 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-19-2021 13:43:39 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913737
Page 222 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-07:00) Mountain
Time (US & Canada)Not Done
7. Test Result:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-19-2021 13:43:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913738
Page 223 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021 13:42:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
Jan-19-2021 13:42:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-08-2020 08:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 13:42:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
Jan-19-2021 13:42:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-08-2020 08:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User ValueReason
Jan-19-2021
19:24:38
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_07
Jan-19-2021
13:42:49
(UTC-07:00)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Clo
sedClose Auto Query
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913739
Page 224 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mountain
Time (US &
Canada)
Jan-19-2021
13:42:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Op
ened'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Jan-19-2021
13:42:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dInitial Entry
Jan-19-2021
13:42:37
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:
NOInitial Entry
Jan-19-2021
13:42:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Data
Entry
:Initial Entry
Dec-08-2020
23:30:51
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6400349;Sample
Collected is not
expected to be Not
Done. Please review
and update
appropriately or clarify
Dec-08-2020
08:46:35
(UTC-07:00)
MountainACV0PFEINFP6000 Data
Entry
:
Not DInitial Entry
090177e196ae30a5\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-2021-5683-0913740
Page 225 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US &
Canada)one
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-19-2021 13:43:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-19-2021 13:43:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pfeChanged
Information
Jan-19-2021 13:42:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text
or between words.
Please correct by
removing all data in
the field and
re-enter without
adding extra spaces
or using enter or tab
keys.
Jan-19-2021 13:42:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PFEInitial Entry
Jan-19-2021 13:42:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-08-2020 08:46:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0913741
Page 226 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-08-2020 07:57:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-08-2020 07:57:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-08-2020 08:47:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-08-2020 07:57:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-08-2020 07:57:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-08-2020 08:47:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ85WInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913742
Page 227 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Dec-08-2020 08:47:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJ85WInitial Entry
090177e196ae30a5\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913743
Page 228 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae30a5\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-2021-5683-0913744
Page 229 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1048 Site Name: (1048) The Pain Center of Arizona
Subject No: 10481032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Dec-08-2020 07:58:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae30a5\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-2021-5683-0913745
Page 230 of 302
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
…[truncated]