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 email@example.com.
The Office of the Vice President for Research has scheduled 2 sessions to introduce the eProtocol system to the research community. The eProtocol system is a web-based platform for IACUC and IBC protocols.
All sessions will be hosted by Dr. Lynn M. Veatch, current site administrator for the eProtocol system and will include representation from the IACUC and IBC. Attendance is open to all and highly recommended for primary personnel working in the system.
In order to know if additional sessions are needed, please drop an email to Dr. Veatch (firstname.lastname@example.org) letting her know the sessions you plan to attend.
Please take this opportunity to learn about this exciting enhancement to our research toolkit.
NIH Notice NOT-OD-17-022 announced NIH’s implementation of Final Research Performance Progress Reports (Final RPPR or F-RPPR) effective January 1, 2017.
The Final RPPR will replace the Final Progress Report (FPR) and will be submitted via a new eRA Commons module.
A significant change with implementation of the F-RPPR is that in order to maximize public transparency, NIH will not maintain the current Type 2 policy which in accordance with NIHGPS Chapter 8.6.2 states that "whether funded or not" the progress report contained in the Type 2 application may serve in lieu of a separate final progress report.
NIH will request that organizations submit an "Interim-RPPR" while their renewal application (Type 2) is under consideration. In the event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution's Final-RPPR.
NIH is aligning its reporting requirement with other Federal research agencies and therefore will not be making any changes to the deadline for submitting the final report- i.e., the Final RPPR or Interim-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date. If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision not to make a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2. NIH also plans to maintain the business rule in the RPPR module enabling institutional signing officials (SOs), at their discretion, to delegate submission of the Final RPPR or Interim-RPPR to the Program Director/Principal Investigator (PD/PI).
Note: Implementation of the Final RPPR for Small Business Innovation and Research (SBIR) and Small Business Technology Transfer (STTR) grants will occur approximately 2 months after implementation for all other NIH grants due to unique final reporting requirements under the Small Business Administration's SBIR/STTR Policy Directive.
FAQs and additional information pertaining to NIH's implementation of the F-RPPR will be available on the NIH RPPR website.
Did you know that we have an online Activity Report training course designed for department coordinators? This class and quiz were designed as a refresher for all current department coordinators and is also a requirement for new coordinators to take after the completion the first level of training with our office. You can find it in MyQuest as, “Accounting 201: Activity Reporting for Department Coordinators”. We would love to get your feedback, email email@example.com