Research Feasibility and Performance

• The MSOM Research Feasibility Committee (RFC) was created to provide a feasibility review of clinical research studies prior to IRB submission.
• The MSOM Research Performance Committee (RPC) was created to complement the work of the RFC by instituting a process to review study performance following study activation.

Which studies will be reviewed by the RPC?

The RPC review process will apply to prospective clinical trials or interventional studies that are screening or enrolling UHealth patients or screening, enrolling or performing research assessments at UMMSoM or UHealth facilities, including:

• Multicenter studies, where the study protocol originated with an industry sponsor.
• Multi-institutional studies initiated by an external group, institution or non-UM investigator.
• Investigator Initiated Studies developed by University of Miami faculty.

The RPC will focus on studies enrolling less than or equal to 50% of their annual enrollment goal to ensure that MSOM is utilizing the clinical research infrastructure efficiently and meeting study enrollment objectives.

What will happen to my existing studies?

The RPC will review enrollment goals and data as entered by principal investigators or their delegates in the IBIS IRB application on a monthly basis.  Studies will be flagged for further review if they are not meeting two or more of the following criteria:

• No participant accrual activity within the last 90 days.
• Less than 50% participant activity (inclusive of screen failures) as compared to local enrollment goal.
• Less than 50% participant enrollment as compared to local enrollment goal.

If an unacceptable rating is received, the PI will receive an Unsatisfactory Accrual Notice (UAN) and have 14 calendar days to provide an Accrual Action Plan.

The RPC will review the Accrual Action Plan and may approve continuation with a six (6) month interval period for the next review or recommend study closure if the action plan is insufficient.

What do I need to do?

Principal investigators should ensure that enrollment goal information is up to date in the Clinical Trial Activity in the IBIS IRB application.

1. Principal investigators should ensure that enrollment goal information is up to date in the Clinical Trial Activity in the IBIS IRB application. 
2. Principal investigators should make sure that the study status is up to date in the Velos Clinical Trial Management System (CTMS).
3. Principal Investigators should ensure that all enrollment data is up to date in the Velos CTMS system or has been reported recently via the REDCap Accruals Reporting form, as per the applicable University of Miami enrollment reporting policy for their study.

Who do I contact with questions?

If you have any questions, please feel free to contact the Research Performance Committee at msomresearchperformance@med.miami.edu.

If you need more information on research resources available to UMMSoM investigators for recruitment, please feel free to contact medresearch@miami.edu or ctsiservices@med.miami.edu.

Committee Members