EQuIP: Education & Quality Improvement Program

The aim of the EQuIP program is to assess and monitor research compliance to promote high quality research conducted within the Rush community. The EQuIP program supports this aim primarily through educating the research community about best practices, local policy, and regulations based upon detected deficits during assessments. The EQuIP data provides the ORC with important information and a better understanding for developing education programs and materials to benefit the research community.

The EQuIP program is a systematic and objective review of research activities. The EQuIP process review may include regulatory, subject, animal, financial, conflict of interest, training records, by comparing data collection forms, data records and source documentation and any records associated with the project.

All active protocols are eligible for audit regardless of funding source. The attempt is to distribute the audits evenly among the various protocols. Although unlikely, a Principal Investigator who is routinely audited once during the year may be routinely audited a second time during the year on a different protocol.

Identification of noncompliance may trigger our institutional policy: Reporting and Investigating Research Non-Compliance. In addition, detected noncompliance may result in formal Corrective and Preventative Action Plans (CAPA).

Research Quality Improvement Audit/Review

A quality assurance review is designed to identify areas of investigator/research team vulnerability regarding adherence to regulatory documentation and protocol requirements. The process identifies areas requiring education and communicates the findings to research administration and the research community.

Not For-Cause (Routine) Audit/Review

Random selection of protocols that examines study related materials to determine if study procedures and data were obtained, recorded, analyzed and reported in compliance with the protocol, policies and procedures, and GCP.

For-Cause (Directed) Audit/Review

This type of review can be requested by the Principal Investigator or research team as a result of study staff transition, a pre-emptive review prior to a sponsor/FDA visit, or as an educational tool for research staff, etc. In addition, these reviews are conducted in response to a complaint, noncompliance issue, unanticipated problem or other reportable event, or a series of concerns/issues. A request from the IRB for a for-cause audit may be initiated due to any concern of the IRB. Upon completion, the results are reported to the IRB if the request came from the IRB, or to the Principal Investigator and study staff pertinent to the study. All requests for a For-Cause audit should be made through the Associate Vice President of the Office of Research Compliance.

Follow-Up Audit/Review

Follow-up audits occur to assess adherence with Corrective and Preventive Action Plans (CAPA) when issued. This review provides additional educational assistance to remedy outstanding compliance matters and to assess whether forms, training, and other assistance that had been provided (post audit) are successful.

Corrective and Preventive Action Plan (CAPA)

The purpose of the Corrective and Preventive Action Plan (CAPA) is to assist the research team in identifying areas of compliance or regulatory concern and in developing processes, forms, etc. to ensure that the deficiencies are not only rectified for the particular study under audit review, but also for other current and future research studies. A CAPA is an educational tool to guide researchers in ensuring the quality of their research and data.

If a CAPA is issued, the research team must return the Plan outlining steps they will take to ensure that any identified issue or problem is rectified and that processes have been put in place to ensure that the issue or problem will not occur again. This may entail development of forms, additional training, or other mechanisms to aid the research team in accomplishing the requirements of the CAPA.

ORC Outreach

The Office of Research Compliance (ORC) is proactive and collaborative to support the research community by providing tools, recommendations and guidance on navigating a complex research environment. See ORC Tool Box for useful templates. The office staff has decades of experience and they are pleased to share their knowledge with others.