For more information, contact Tammy Loy at firstname.lastname@example.org or (865) 974-5969
Our mission is to support the University’s expectations of high-quality research via quality assurance (QA) and quality improvement (QI) activities. Identifying the strengths and weaknesses of protection efforts is essential to maintaining a quality program and enables DRIA to continue UT’s tradition of excellence. The QA/QI office will be conducting internal monitoring of the HRPP office to improve the program, procedures, and performance. Reviews of active campus research will be done to ensure that the participants’ rights, safety and welfare are protected, that the research is conducted in accordance with the approved research plan and complies with all applicable Federal regulations and University policies.
How it Works
- Made Approximately 2-4 weeks prior to audit
- Auditor confirms study status and may solicit subject enrollment information
- Auditor determines scope of audit, mechanism of review, and materials required for audit.
- On site audits (generally of greater than minimal risk research):
- Typically include a review of a selection of subject charts, and may include logs of any kind related to the study.
- On-site audit (typically 1-3 days)
- Remote audits (generally of minimal risk research):
- Typically include review of a selection of subject charts and a Q&A form completed by the study team prior to the audit.
- A summary of audit findings may be provided to the PI via email following audit completion in lieu of a closeout meeting.
- Auditor reviews IRB file to become familiar with the study, including changes to protocol, consent/ assent documents, other study materials, and study team over time.
- If UT is not the IRB of record, IRB files will be requested from the study team.
- When the audit is conducted on-site, activities include an introduction meeting, study team interviews as necessary, and review of selected study materials. Study team member is not required to be present at all times (periodic check-in only).
- When the audit is conducted remotely, the auditor may need to seek additional information from the study team by phone or email during the audit in order to complete the review.
- An auditor may expand the scope of audit at any time during the audit process.
- When a closeout meeting is to occur (generally all audits of greater than minimal risk research will require a closeout meeting), the PI is required to attend. Other study team members are encouraged to attend.
- Key findings, appropriate Corrective Action Plans, and timeline for report are discussed.
- A closeout meeting for a minimal risk research audit may only be required if findings warrant further review/ discussion to resolve issues and or corrective action is required before the final audit report is issued. In such instances, the PI is required to attend.
- Audit report is completed and sent to PI and study contact by email approximately 10 days after the audit is complete.
- Report includes guidance from auditor regarding appropriate and thorough responses.
- PI responses (if requested) are due 2 weeks following receipt of the audit report.
- Auditor reviews responses and clarifies any remaining issues.
- Auditor provides PI and study team with final audit report and responses.
- When directed to do so in the auditor’s communication, PI and study team submit the final audit report and responses to iMedRIS as a reportable event (Form 4).