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Children's Health Performance Site Approval Application

Thank you for choosing Children's Health as a study performance site. The Performance Site Review (PSR) form is designed to provide study operational, fiscal and regulatory information to Children's Health Research Administration (CHRA).

The CHRA is committed to ensuring feasibility of your study and patient safety; therefore, to facilitate the timely approval of your study the following requirements are crucial.

- Completion of this form in its entirety.
- Answer each question thoroughly.
- Provide as much detail as possible.
- Please be aware an incomplete form submission will result in delaying your study approval because the PSR form may be returned to you for further information.
- Non-regulated research projects do not need to complete this form. Performance Site approval for non-regulated research studies will be issued by our Vice President for Research.
  
  For an update on your study, please email: Non-RegulatedResearch@Childrens.com.

, Velos#

Reviewer:

Reviewer "Other":

Date of Initial PSA request in Velos:

M-D-Y

Date of Initial PSA Acknowledgement:

M-D-Y

Study Title:

* must provide value

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PI First Name:

* must provide value

PI Last Name:

* must provide value

Study Type:

* must provide value

Non-Regulated Research

Non-Human Subjects Research

Single Patient IND

Compassionate Use/Expanded Access Program

Exempt

Expedited

Full Board

Reliance: Minimal Risk

Reliance: Greater than Minimum Risk

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Is this research study an Artificial Intelligence (AI) or Machine Learning project?

* must provide value

Yes

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Is this study only retrospective in nature (chart review of clinical data or accessing specimens on hand)?

* must provide value

Yes

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Funding Source:

* must provide value

Academic

Federal

Industry

Internal

Private

Public

Funding Agency/Entity:

* must provide value

Does this study use an external IRB review?

* must provide value

Yes

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Name of IRB:

External IRB Number:

Reliance Agreement Execution Date:

M-D-Y

UTSW HRPP Acknowledgement Date:

M-D-Y

Velos Number:

* must provide value

Velos Number (if available):

UTSW IRB Number:

* must provide value

UTSW IRB Number (if available):

IRB Submission Date:

M-D-Y

Current IRB status:

Draft

Faculty Sponsor Review

Department Chair Review

Changes Required by Department Chair

In (Exempt/Expedited) Review

Assigned To IRB Meeting

IRB Staff Review

Changes Required or Submission Not Complete

Awaiting Correspondence

Awaiting Activation

Activated

Approved - Other Approvals Pending

NSC - IRB Staff Review

Other

Closed in eIRB

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Current IRB Status "Other":

IRB Approval Date:

M-D-Y

IRB Not Activated - IRB approved, Other Approvals Pending

M-D-Y

IRB Activated - Minimum Approvals Received

M-D-Y

Study Principal Investigator (PI):

First Name ______

Last Name ______

Principal Investigator Contact Information

First Name: ______ Last Name: ______

Credentials:

Department: ______

Email: ______

PI Department:

* must provide value

PI Department Other Please Explain:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Center:

* must provide value

PI Email:

* must provide value

Is there a Primary Research Coordinator (PRC) for this study?

* must provide value

Yes

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Primary Research Coordinator (PRC) Contact Information

First Name: ______

Last Name: ______

Email: ______

PRC First Name:

* must provide value

PRC Last Name:

* must provide value

PRC Email:

* must provide value

Is there a Primary Administrative Contact (PAC) for this study?

* must provide value

Yes

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Primary Administrative Contact (PAC) Contact Information

FIrst Name: ______

Last Name: ______

Email: ______

PAC First Name:

* must provide value

PAC Last Name:

* must provide value

PAC Email:

* must provide value

Does this study have a ClinicalTrials.gov number (NCT Number)?

* must provide value

Yes

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NCT:

* must provide value

Study Phase:

* must provide value

Study Phase "Other" Please explain:

* must provide value

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Which services are needed to conduct study:

Advanced Analytics (required if a Children's Health system will be accessed to collect data)

Biostatistician

Children's REDCap

Other Ancillary services (EEG, dental, mental health, etc.)

Special Procedure Unit (Infusion of study treatment)

Audiology

Ophthalmology

Sleep Study

Psychology

Radiology Imaging/Services - (MRI, ECHO, MUGA, CT, PET, MR, XR, DEXA Bone Scan, etc.)

Swallow Test, Lumbar Puncture

Speech Language Pathology, Physical Therapy, Rehabilitation Aide, or Occupational Therapy

GI Procedures (EGD, Colonoscopy, etc)

Anesthesia Services

Neurology Clinic Utilization

Other

Interpreter/Interpretation

None

A copy of the study protocol, Imaging Manual, and/or other documents related to radiological services must be sent to; RadResearch@childrens.com and jayni.george@childrens.com and daniyal.kamal@childrens.com.

Date imaging documents sent:

* must provide value

M-D-Y

Please explain "Other:"

* must provide value

Is this study utilizing drug treatments that are either "Investigational, not FDA approved" or "FDA approved/Use is not FDA Approved"?

* must provide value

Yes

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A copy of the study protocol, IB, and pharmacy manual (if available) must be sent to IDSRx@childrens.com.

Date IDS documents sent:

* must provide value

M-D-Y

Is there data sharing with external collaborators?

* must provide value

Yes

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Are there billable charges at Children's Health?

Yes

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Check box if any agreements are required between Children's Health and external entities:

* must provide value

DUA

MTA

BAA

CTA

Check box if any agreements are required between UTSW and external entities:

*Refer to UTSW Office for Technology Development for additional information.

DUA

MTA

BAA

CTA

On which campus(es) will research occur?

* must provide value

Dallas

Plano

Andrews (Plano, Frisco, Prosper)

Other

"Other" campus/campuses where research will occur:

* must provide value

Children's Health℠ Andrews Institute Orthopedic Walk-in Clinic Plano

Children's Health℠ Primary Care 15th Street

Children's Health℠ Primary Care Eldorado Parkway

Children's Health℠ Pulmonary Care Specialists Dallas

Children's Health℠ Pulmonary Care Specialists Plano

Children's Health℠ Sleep Disorders Center Plano

Children's Health℠ Sleep Disorders Center Dallas

Children's Health℠ Specialty Center Allen

Children's Health℠ Specialty Center Cityville

Children's Health℠ Specialty Center DeSoto

Children's Health℠ Specialty Center Grapevine

Children's Health℠ Specialty Center Mockingbird 1

Children's Health℠ Specialty Center North Rockwall

Children's Health℠ Specialty Center Park Cities

Children's Health℠ Specialty Center Plano #1

Children's Health℠ Specialty Center Plano #2

Children's Health℠ Specialty Center Preston

Children's Health℠ Specialty Center Prosper

Children's Health℠ Specialty Center Redbird

Children's Health℠ Specialty Center Richardson

Children's Health℠ Specialty Center South Rockwall

Children's Health℠ Specialty Center Waxahachie

Children's Health℠ Urology Walnut Hill

Lovejoy Pediatrics

Pediatric Associates of Wylie

Pediatric Heart Specialists Alliance

Pediatric Heart Specialists Arlington

Pediatric Heart Specialists Dallas

Pediatric Heart Specialists Ennis

My location is not listed above

"My location is not listed above" Please define:

* must provide value

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Specific location where research will occur:

* must provide value

Inpatient

Outpatient

Both Inpatient and Outpatient

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Please clearly define the Inpatient and/or Outpatient location (i.e. clinic space, unit, floor):

* must provide value

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Is your study enrolling or interacting with participants who are ≥ 19 years of age?

* must provide value

Yes

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Will anyone ≥ 19 years of age be seen or engaged with at Children's Health?

* must provide value

Yes

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Adult Patient Recruitment intake form must be completed in C360.

Date adult patient recruitment was requested in C360:

M-D-Y

Date adult recruitment committee decision was received:

M-D-Y

Was adult recruitment request approved?

Yes

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Does the study involve administration of a therapy (drug/biologic or implantable device)?

* must provide value

Yes

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What clinical or hospital location will the therapy be administered?

* must provide value

Will your study require prospective collection, assessment, or preparation for shipment of any biological samples (e.g., blood, CFS, urine, sputum, human cell/tissue samples, bone marrow aspirate, stool, or any other human derived samples)?

* must provide value

Yes

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Does the study require collection of pathology/histology specimens?

* must provide value

Yes

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Will your study require collection of archived (on hand) biological samples (e.g., pathology, histology samples)?

* must provide value

Yes

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A copy of the study protocol and lab manual must be sent to; LabResearchAdmin@childrens.com, jayni.george@childrens.com, and daniyal.kamal@childrens.com.

Date when the protocol/lab manual was submitted to CMC Pathology/Laboratory Department for review:

* must provide value

M-D-Y

Date when lab support email/letter was generated:

D-M-Y

Will blood product, tissue, and/or other biologics (CSF, Bone Marrow Aspirate, Urine, Feces, etc.) be collected and shipped to the spsonsor (or sponsor representative) - outside of the covered entity?

* must provide value

Yes

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Will members of CMC laboratory/pathology department assist with sample preparation and shipment to external collaborator?

* must provide value

Yes

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Will a member of the study team be assigned to ship biological samples to sponsor's lab?

* must provide value

Yes

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Please identify the research team member(s) assigned and upload a copy of IATA certification.

* must provide value

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Please upload research team member(s) IATA certification.

Upload file

Is the study sponsor providing any of the following technologies?

* must provide value

Medical diagnostic equipment (e.g., ECG, Infusion Pumps, diffuse correlation spectroscopy),

Biometric devices (e.g., Fibit),

Electronic devices (tablets, Android Devices, iPhones, laptops, printers, e-diary, etc.),

Utilization of a mobile application or other software to be used on Children's issued devices (iPad, iPhone, tablet, etc.) or healthcare system,

Systems that will attempt to integrate with a CMC system (e.g., Children's EPIC)

Utilization of "cloud" storage or computing infrastructure (e.g., Dropbox, Amazon Cloud Services, EC2)

Other

None

Standard Review Quick Reference Guide

Attachment:Requesting Standard Review Assessment - Quick Reference Guide_CleanCopy_05312022.pdf

Please explain "other:"

* must provide value

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Name of device/technology:

* must provide value

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RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

Is Children's protected health information (PHI) being accessed, collected, stored, or transmitted (e.g., ePHI, PHI, HR, Financial, ePII, PII, etc.) outside of the covered entity (to external collaborators)?

* must provide value

Yes

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Will the system, device, or interface need to connect to the Children's Health network (internal or guest) for data transmission?

* must provide value

Yes

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Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

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Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

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Do you have additional Medical Diagnostic Equipment for this study?

* must provide value

Yes

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Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Medical Diagnostic Equipment for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Biometric Equipment for this study?

* must provide value

Yes

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Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Biometric Equipment for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Electronics for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Electronics for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Mobile Applications or Software for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional Mobile Applications or Software for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional System Integration Requests for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional System Integration Requests for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional System Integration Requests for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Do you have additional System Integration Requests for this study?

* must provide value

Yes

reset

Name of device/technology:

* must provide value

Expand

RITM#

RITM Submission Date:

M-D-Y

RITM Resolution Date:

M-D-Y

* must provide value

Yes

reset

Will the system, device, or interface need to connect to the Children's Health network (internal or Guest) for data transmission?

* must provide value

Yes

reset

Will any of the sponsor issued devices produce Radio Frequency (RF) that may cause interference with hospital owned equipment in the Children's environment?

* must provide value

Yes

reset

Is the sponsor proposing architectural changes to any existing implementations at Children's Health? Or are there any requested changes to previously reviewed requests?

* must provide value

Yes

reset

Co-Investigators

Please indicate how many Co-Investigators will be working with Children's Health patients, Children's Health staff, or accessing any Children's Health patient information, campuses, or resources. Please include all individuals conducting any research at Children's Health for this study.

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

Co-I Name:

* must provide value

PRC Name: ______ ______

PAC Name: ______ ______

Other Study Personnel

Please indicate how many Other Study Personnel will be working with Children's Health patients, Children's Health staff, or accessing any Children's Health patient information, campuses, or resources. Please include all individuals conducting any research at Children's Health for this study.

OSP Name:

Is study assessing the safety and/or efficacy of a treatment agent or medical device that will either be implanted (e.g., heart valves, pacemaker, LVADs, lenses for the eye, cochlear implants, insulin pumps, gastric stimulators, deep brain neurostimulators, etc.) or dispensed to the study participant for use in the study?

* must provide value

Yes

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Medical Devices

Please indicate how many Medical Devices will either be implanted (e.g., heart valves, pacemaker, LVADs, lenses for the eye, cochlear implants, insulin pumps, gastric stimulators, deep brain neurostimulators, etc.) or dispensed to the study participant for use in the study?

* must provide value

Name of device:

* must provide value

Expand

______

Name of sponsor/manufacturer:

* must provide value

Expand

______

Is device implantable or non-implantable?

* must provide value

Expand

______

Indication for use:

* must provide value

Expand

______

Location of storage:

* must provide value

Expand

______

Has the sponsor provided an implantable device log to track the use of device?

* must provide value

Yes

reset

______

Please upload a copy of the retention and assignment plan including a copy of the log:

* must provide value

Upload file

______

At the conclusion of the project, what is the plan to send back any unused and/or defective study device?

* must provide value

Expand

Name of device:

* must provide value

Expand

______

Name of sponsor/manufacturer:

* must provide value

Expand

______

Is device implantable or non-implantable?

* must provide value

Expand

______

Indication for use:

* must provide value

Expand

______

Location of storage:

* must provide value

Expand

______

Has the sponsor provided an implantable device log to track the use of device?

* must provide value

Yes

reset

______

Please upload a copy of the retention and assignment plan including a copy of the log:

* must provide value

Upload file

______

At the conclusion of the project, what is the plan to send back any unused and/or defective study device?

* must provide value

Expand

Name of device:

* must provide value

Expand

______

Name of sponsor/manufacturer:

* must provide value

Expand

______

Is device implantable or non-implantable?

* must provide value

Expand

______

Indication for use:

* must provide value

Expand

______

Location of storage:

* must provide value

Expand

______

Has the sponsor provided an implantable device log to track the use of device?

* must provide value

Yes

reset

______

Please upload a copy of the retention and assignment plan including a copy of the log:

* must provide value

Upload file

______

At the conclusion of the project, what is the plan to send back any unused and/or defective study device?

* must provide value

Expand

Name of device:

* must provide value

Expand

______

Name of sponsor/manufacturer:

* must provide value

Expand

______

Is device implantable or non-implantable?

* must provide value

Expand

______

Indication for use:

* must provide value

Expand

______

Location of storage:

* must provide value

Expand

______

Has the sponsor provided an implantable device log to track the use of device?

* must provide value

Yes

reset

______

Please upload a copy of the retention and assignment plan including a copy of the log:

* must provide value

Upload file

______

At the conclusion of the project, what is the plan to send back any unused and/or defective study device?

* must provide value

Expand

Name of device:

* must provide value

Expand

______

Name of sponsor/manufacturer:

* must provide value

Expand

______

Is device implantable or non-implantable?

* must provide value

Expand

______

Indication for use:

* must provide value

Expand

______

Location of storage:

* must provide value

Expand

______

Has the sponsor provided an implantable device log to track the use of device?

* must provide value

Yes

reset

______

Please upload a copy of the retention and assignment plan including a copy of the log:

* must provide value

Upload file

______

At the conclusion of the project, what is the plan to send back any unused and/or defective study device?

* must provide value

Expand

Please type "SUBMIT" when you are ready to submit your PSA application.

* must provide value

PDF of Submission

Upload file

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Children's Health Performance Site Approval Application

Thank you for choosing Children's Health as a study performance site. The Performance Site Review (PSR) form is designed to provide study operational, fiscal and regulatory information to Children's Health Research Administration (CHRA).

The CHRA is committed to ensuring feasibility of your study and patient safety; therefore, to facilitate the timely approval of your study the following requirements are crucial.

Completion of this form in its entirety.

Answer each question thoroughly.

Provide as much detail as possible.

Please be aware an incomplete form submission will result in delaying your study approval because the PSR form may be returned to you for further information.

Non-regulated research projects do not need to complete this form. Performance Site approval for non-regulated research studies will be issued by our Vice President for Research.

For an update on your study, please email: Non-RegulatedResearch@Childrens.com.

, Velos#

Services Needed to Conduct Study at Children's:

Lab & Pathology

Standard Review

Medical Diagnostic Equipment:

Biometric Devices:

Electronic Devices:

Mobile Applications or Other Software on CHST Devices:

System Integration:

Cloud Storage or Computing:

Credentialing Form B

Principal Investigator (PI):

Administrative Contacts (PRC and/or PAC):

Medical Devices

You have selected an option that triggers this survey to end right now.

Children's Health Performance Site Approval Application

Thank you for choosing Children's Health as a study performance site. The Performance Site Review (PSR) form is designed to provide study operational, fiscal and regulatory information to Children's Health Research Administration (CHRA).

The CHRA is committed to ensuring feasibility of your study and patient safety; therefore, to facilitate the timely approval of your study the following requirements are crucial.

Completion of this form in its entirety.

Answer each question thoroughly.

Provide as much detail as possible.

Please be aware an incomplete form submission will result in delaying your study approval because the PSR form may be returned to you for further information.

Non-regulated research projects do not need to complete this form. Performance Site approval for non-regulated research studies will be issued by our Vice President for Research.

For an update on your study, please email: Non-RegulatedResearch@Childrens.com.

______, ______ ______ ______ Velos# ______ ______

Services Needed to Conduct Study at Children's:

Lab & Pathology

Standard Review

Medical Diagnostic Equipment:

Biometric Devices:

Electronic Devices:

Mobile Applications or Other Software on CHST Devices:

System Integration:

Cloud Storage or Computing:

Credentialing Form B

Principal Investigator (PI): ______ ______

Administrative Contacts (PRC and/or PAC):

Medical Devices

You have selected an option that triggers this survey to end right now.

, Velos#

Principal Investigator (PI):