The Rush Office of Research Compliance views quality improvement as an integral part of its overall mission, vision and values. A mechanism for assessing improvement provides a measure of our program's effectiveness. The Evaluation Quality Improvement Program or EQuIP assesses the adequacy of investigator/research team compliance with regulatory requirements, protocol organization and record-keeping. The process highlights areas requiring education and fosters enhanced communication between research administration and the research community. Review and analysis of the data gathered during the EQuIP process informs ORIRA of gaps in knowledge that can be addressed directly. The information will lead to a better understanding for developing educational programs and materials that will benefit the research community.

The EQuIP process systematically compares investigators research records with the corresponding IRB-approved protocol. The EQuIP process involves review of study files, regulatory and subject records that include case report forms, data records and/or source documentation and any research records associated with the project (i.e., contract).

Criteria for Evaluation of Protocols:

• Human subjects studies
• Subjects enrolled in active studies (can be in follow-up)
• Recent studies (within a year or two of the current date)
• Full IRB review required (exempt or expedited excluded)

The EQuIP Process notifies the principal investigator (PI) that his/her study has been randomly selected and is pending evaluation. ORC schedules a mutually convenient meeting with an appropriate research team member (typically 2 weeks after the initial notification) and conducts the review. Subsequently, ORC issues a draft summary of observations to the PI to ensure that the evaluator understood, accurately depicted and made appropriate recommendations about the study. Once the PI responds to the draft, ORC generates a final summary evaluation letter to the PI with copies to the department chair or section director, the IRB chairs, the Director of human subjects protections, and the Associate Provost for Research.

• Trends in knowledge deficiencies
• Incomplete documentation
• Remedial education

Any identification of noncompliance triggers our institutional policy on "Suspensions/Involuntary Terminations and Reporting of Suspensions/Involuntary Terminations."

Rush investigators conduct studies according to governmental regulations and institutional policies. Identification of noncompliance may result in corrective action plans (CAP).

Please contact Stephanie Guzik, RN, BSA, MBA at (312) 942-1296 for any questions regarding the EQuIP process.