Staffing shortages and a high volume of study submissions have created a significant backlog of studies awaiting Coverage Analysis review. The Coverage Analysis team is working as quickly as possible, and the Office of Clinical Research (OCR) is actively recruiting to fill vacant positions; however, researchers may experience long wait times. As a completed Coverage Analysis is required prior to enrollment for any protocol with items or services potentially billing through any healthcare partner, please ensure your research teams are following these best practice recommendations to reduce the likelihood of a delay in enrollment.
• Submit to the OCR early, with your final protocol, draft informed consent(s), and draft budget/CTA, award, or other funding agreement. Studies cannot be assigned for review until all required documents are received.
• Respond to Coverage Analyst communication and meeting requests in a timely manner.
• Ensure OnCore IRB status is up to date and all necessary billing fields are complete when applicable (internal account number, NCT#, PO numbers, etc.).
Study teams should not begin enrollment until the OnCore status is “Open to Accrual.” If you have questions, email firstname.lastname@example.org.
The views expressed in this content represent the perspective and opinions of the author and may or may not represent the position of Indiana University School of Medicine.
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