Page 230 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q010
SOP Title: PERFORMANCE SITE APPROVALS (PSA) PROCESS FOR EXTERNAL IRB APPROVED PROJECTS
summary of the project including ancillary services lines such as IDS, Lab/Pathology, radiology that may need to provide services during the conduct of the study.
4. Quality Specialist(s) requests electronic copies of the external IRB-approved application, list of IRB approved research staff members tasked to perform the study, approved protocol, approved Investigator Brochure (if applicable), Clinical Trial Number (if applicable), FDA form 1571 or 1572 (if applicable), and Clinical Trial Cost Coverage Analysis (CTCA). For studies without a CTCA or similar document, assigned QS team member will update senior Research Administrators so that an internal CTCA determination may be performed to verify the payers in question.
5. Quality Specialist(s) creates a file that contains the initial notification and the ‘Checklist for Performance Site Approval (PSA) request’.
6. Quality Specialist(s) logs the new PSA notice in RedCap.
7. Quality Specialist(s) reviews the study staff approved by the external IRB for
completion of Children’s HealthSM Children’s Medical Center credentialing /
training, noting any deficiencies.
8. Quality Specialist(s) acknowledges the receipt of all received study-related
documents via email to the PI and Coordinator using the template PSA acknowledgement email, and:
a. Notifies of any credentialing / training deficiencies and provides contacts for completion.
b. Notifies that a Delegation Log may be needed.
c. Notifies a CTCA will be required if the PI’s institution does not require
CTCA’s as part of their research billing practice. Alternatively, a CTCA determination may be performed in house by members of RA administration.
d. Notifies that a Service Order Agreement may be required and provides instructions for completion.
e. Requests confirmation of who will be completing submissions and provides contacts to facilitate setting up the research account.
9. Assigned
a. Reviews and compares all IRB documents for consistencies and/or
QS team member reviews the study documentation:
missing data
b. After discussing with Leadership, an email is sent to the PI and
Coordinator requesting clarification of any inconsistencies found.
10. When the review is complete and all clarifications are made and any revisions are
complete, the Quality Specialist(s) emails the Medical Director that the review is completed and the study is ready for his review and approval. An executive summary along with copies of the protocol, IB, and pertinent supporting documents (IC/HIPAA, etc.) is forwarded to the Research Administration Medical Director to utilize and review for site approval consideration since there is no access to the external IRB’s electronic database for these projects.
SOP No. 9, 12-20-2018