The Office of Research Development is hosting a PCORI Workshop on July 18, 2018. The details are underdevelopment but I wanted to have faculty Save-the-Date. The workshop will be 3-hours and two program officers from PCORI will be on campus to provide details regarding the organization, funding opportunities available, and an overview of the engagement requirements. Dr. Kathleen Brady asked that PCORI also discuss plans for their sustainability.
Since the memo of understanding was signed in October 2016 to establish a new Office of Clinical Research, much of the activity has involved setting up MUSC’s newest Research Administration Office. Most of the staff have been hired and space secured in Suite 170 in the Roper Medical Office Building, just down the hall from the SCTR offices. New workflow processes and training are being developed, as well as tools and metrics, to guide study teams in understanding what research billing compliance entails. Clinical research billing compliance in this context is often referred to as prospective reimbursement analysis.
The purpose of the Office of Clinical Research is outlined below, but to better understand how the OCR fits into the MUSC Research community, this organization chart illustrates how we are positioned.
Important to note, is that the OCR is a collaboration between MUSC Administration, College of Medicine, and MUSC Health.
Effective May 1, all new clinical research studies must have a clinical billing compliance review called a Prospective Reimbursement Analysis (PRA). The OCR has been busy providing information for faculty members, and meeting and providing more detailed training to study team about the new PRA workflow process. The OCR PRA Team is seeking information from departments and the research community to improve the OCR and research processes.
The goal of the billing compliance review process is to facilitate the research study activation process as well as to ensure compliance, so please submit studies early in the study activation process. The OCR PRA Team will work alongside the study team to complete the PRA in parallel with the study team completing the budget. The PRA will provide valuable information to support budget development and contract negotiation. Eventually, the prospective reimbursement process (PRA) should improve the process and reduce the time of setting up a clinical research study.
We encourage the MUSC Research Community to visit the OCR internal website at: http://horseshoe.musc.edu/research/ocr. Browse the pages for Training and Resources, Announcements and updates both from the OCR and the Epic Research Team. Our external-facing website is primarily for industry sponsors.
The horseshoe sites are most easily accessed if you are on campus. If off campus, you may have use a VPN to log in. In addition, you can contact the OCR office at 843-792-7900 or at firstname.lastname@example.org.
To the MUSC Research Community:
On behalf of Vice President for Research, Dr. Kathleen Brady, we are pleased to announce the creation of a new online MUSC Research Events Calendar available to our community.
The Research Calendar provides a one-stop shop to view research events that are open to the MUSC community and external public audiences. The calendar provides views by date or by calendar month, and has a tab for viewing clinical trials for recruitment that are not typically bounded by date ranges. Public audiences can view events by going to the research homepage research.musc.edu and click on Upcoming MUSC Research Events.
Many thanks to Kristi Adams, Carla Frichtel, and Teresa Kelechi for this support of this endeavor!
Loretta Lynch-Reichert, M.S.
Director, Office of Strategic Initiatives and Policy Management
Office of the Provost
Medical University of South Carolina
National Institutes of Health announced that all NIH-funded clinical trials (whether its direct or pass-through) that will be active on or after January 1, 2017, investigators, and clinical trial staff(as defined) will need to complete Good Clinical Practice (GCP) training for NIH Awardees involved in NIH-funded Clinical Trials, and expectations for training. More information can be found here: NOT-OD-16-148.