Page 143 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q004
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process
o Workbook Documentation – For projects requiring assistance from Advanced Analytics (AA) for EPIC screening reports or other report types, assigned QS reviewer will document requirements and provide guidance to the research team for submission of a AA request.
o WorkbookDocumentation–Forprojectswherepatients≥19yearsofage will be recruited, assigned QS specialist will document requirement for completion of Adult Patient Recruitment form and the Children’s leadership committee decision regarding inclusion of adult patients.
o Workbook Documentation – For projects that utilize technologies and medical devices that interact with Children’s network, assigned QS reviewer will assess the device/technology and will provide guidance for Standard Review (SR) Assessment. A ServiceNow SR request will be required prior to PSA.
o Workbook Documentation – For projects that require Facility Use Agreement, assigned QS specialist will documentation date of initiation and execution of the agreement.
o Workbook Documentation - For projects will research billable patient charges and research services, documentation that an agreement will be needed is noted in the Workbook.
6. PROCESS MAP
Research Administration
RQS
Create file that contains Velos notification and checklist for PSA submissions. LOGs PSA info into internal records.
RQS
Reviews that all study staff is approved by the IRB for credentialing, has completed training, etc.
Start
RQS
Acknowledges receipt of PSA email to PI & Coordinator noting deficiencies in:
• Credentialing • Training
Obtains confirmation on who will complete Velos/Reveal submissions & notifies team on: • Need for delegation log
• Pricing Quote Form/Contract
• 1572 (If applicable).
Notification is received in mailbox for a performance site approval request in Velos.
RQS
Changes status in Velos to Pending Review.
RQS
• Reviews all IRB & Velos documents • Prepares review notes
• Clarifies inconsistencies
• IRB Approved Protocol & CTCA submitted to research finance team for billable charges review.
RQS
Email request to Medical Director for approval.
Medical Director
Velos Status updated too “PSA Approved” in Velos.
End
SOP No. 3, Date: 4/13/16; revised 5/3/16; 7/5/16; 8/2/16; 09/18/2017; 03/19/2018; 03/19/2019; 07/17/2020; 11/02/2020; 02/25/2021; 06/03/2021