"What is the Office of Research Compliance and Education?"

The Office of Research Compliance and Education (ORC), developed in 2003, provides on-going support to the research community through research monitoring and education programs. The goals of the ORC are to ensure proper scientific, ethical and regulatory requirements are followed in research protocols conducted at UHCMC and to promote research integrity through education.

"What services does the ORC provide?"

The ORC conducts routine and for cause monitoring reviews and provides educational resources to Investigators and their research staff. On-site monitoring reviews are conducted by one or more qualified ORC staff. The ORC staff review regulatory documentation, reconciles Institutional Review Board (IRB) documentation, and reviews subject files including consent forms. Additional aspects of study conduct may also be reviewed. All on-site reviews include an exit interview and written report, both of which address all on-site observations, corrective actions and quality improvement recommendations. The ORC staff have the knowledge, expertise and experience to assist study sites as they prepare for upcoming audits by the FDA, NIH, sponsors or other external agencies. In addition, the ORC publishes a monthly newsletter, Research Collaboration Corner, to provide research and policy related updates and useful tools for researchers.

"How are research protocols selected for monitoring?"

The ORC periodically selects UHCMC IRB approved protocols for review and invites Investigators to participate in the on-site monitoring review. Monitoring is conducted in the form of directed (for cause) and prospective (routine) reviews. Directed monitoring of IRB approved research is conducted in response to concerns identified by the IRB, complaints by sponsors or subjects, requests from institutional officials or concerns from federal agencies (e.g., FDA, OHRP, and NIH). P rospective monitoring is conducted to assess the investigator's compliance with Federal, state and local law and UHCMC and IRB policies. Protocols involving vulnerable populations, high risk interventions, and investigator-initiated studies may be selected more frequently for review.

"What is the process for monitoring reviews?"

• Written notification of a pending review will be sent from the ORC to the Investigator and the Research Compliance Specialist will schedule the visit by mutual convenience. In preparation for the on-site review, the Research Compliance Specialist will review the corresponding IRB record and grant file to ensure an accurate understanding of the research study objectives and procedures.
• The on-site monitoring review begins with a brief interview with the study coordinator and/or principal investigator to review the study, and understand roles and responsibilities of the research team.
• During the monitoring visit, the following elements will be reviewed: regulatory binder; subject's research records; required elements of informed consent form; informed consent process; and protocol adherence.
• In addition, the informed consent process may be observed, although this is often scheduled as a separate event.
• Once the monitoring review and observation of the informed consent document are complete, a summary of the observations will be sent to the principal investigator and applicable study staff. A copy will be filed with the Center for Clinical Research.

"How do I receive more information about the ORC?"

For more detailed information, please contact Carol Fedor, ND, CCRC, Clinical Research Manager at 216-844-5524 or Carol.Fedor@UHhospitals.org.

To be placed on the distribution list, please contact Deb Marko, MA, at Deborah.Marko@UHhospitals.org. Please register for educational sessions at: http://ora.ra.cwru.edu/research/orc/education/onlinecalendar.cfm.

Office for Human Research Protections (OHRP) Frequently Asked Questions.