The Rush Office of Research Compliance (ORC) views Quality Improvement as an integral part of its overall mission, program, and responsibility. Mechanisms for assessing improvement must be in place to measure the effectiveness of the program. The Evaluation Quality Improvement Program (EQuIP) identifies areas of investigator /research team vulnerability regarding adherence to regulatory requirements, protocol, organization, and record keeping. The process highlights areas requiring education, and fosters enhanced communication between research administration and the research community. Data gathered during the EQuIP project provides ORC with an understanding of gaps in knowledge that can later be addressed with the research community. The EQuIP data gathered provides the ORC with important information and a better understanding for developing education programs and materials that will benefit the research community.
The EQuIP process is a periodic, systematic and objective review of the clinical trial activities which ensure the trial is performed and the data generated is documented and reported in compliance with Good Clinical Practice (GCP). The EQuIP process requires review of regulatory and subject records that include case report forms, data records and/or source documentation and any records associated with the project (i.e., contract).
Selection Criteria for Evaluation of Protocols:
- Only trials that involve human subjects
- Active research with subjects enrolled (can be in follow up)
- Recent/contemporary studies (within the last 3 years)
Content areas to be reviewed may include:
- Conflicts of Interest (COI) Management Plans
- Medicare Coverage Analysis
- Good Clinical Practices (GCP)/ Human Research Protections Program (HRPP)
- Investigational Product Accountability
Identification of noncompliance may trigger our institutional policy on "Reporting and Investigating Research Non-Compliance." In addition, detected noncompliance may result in formal corrective and preventative action plans (CAPA).
Please contact Stephanie Guzik, MBA, BSN, RN, CHRC at (312) 942-1296 for any questions regarding the EQuIP process. More information including the Rush policy and procedure about the EQuIP project can be found here.