Page 248 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q014
SOP Title: Rejection of Performance Site Review Request in Velos
1. PURPOSE
In order to more effectively serve the research community, RA will grant up to 90 days to the research team to provide all requested items and clarifications to questions before site approval can be granted. For those who don’t comply, the performance site review (PSR) will be disapproved in Velos, and the researcher will be given the opportunity to address all requested items before resubmitting a follow-up PSR request to Children’s Health.
2. INTRODUCTION
A performance site review request is intended to inform the affiliated institution (i.e. Children’s Health, Parkland Health and Hospital System, Aston, etc.) that research activities including research services are being performed. The affiliated institutions responsibility is to ensure that all research staff members on a given project have appropriate credentialing (or documentation of attestation from the Principal Investigator (PI)) in place, and the project has been reviewed and approved to take place at said institution.
Children’s Health Research Administration (RA) encourages researchers to submit a PSR request concurrent to an eIRB application submission. This is partly due to rate limiting factors such as credentialing and investigational medical device clearance at Children’s Health.
It should be noted that site approval will not be granted until the researcher has fully complied with the requested item(s), a follow-up PSR has been requested in Velos, an RA review has been completed, and site approval granted.
For other cross-functional processes, it is good practice and common expectation at Children’s Health and from industry best practices that procedures must be in place to ensure accountability, traceability, and consistency in fulfilling regulatory and clinical requirements.
3. SCOPE
This SOP applies to all departments conducting research at Children’s Health.
4. REASONS FOR PSA REJECTION
Reasons to disapprove a PSR at 90 days following receipt of request:
• A Clinical Trials Coverage Analysis (CTCA) has not been requested by members of the Research Team.
• SOA not initiated by study team.
• Institutional Review Board (IRB) status remains unapproved.
• Major concerns with IRB application, Quality Specialist (QS) verification with the
UTSW IRB that modification to the protocol is required. However, no formal action has been taken by the PI to address concerns.
SOP No. 14, 08-20-2021; 06-02-22