Research Administration Updates April 19, 2017 11:00 am IOP Auditorium

Topics Covered Epic Research Upgrade – Lucas Moreira Under separate presentation link Office of Clinical Research update - OCR Recent Notices & Update/Reminder - ORSP

Office of Clinical Research (OCR)

OCR Team

OCR Mission Partnering Ensuring research billing compliance Supporting clinical research operational and financial performance

OCR Goals Ensure billing compliance Increase efficiency Support participant accrual Improve financial performance Metric Tracking and Reporting

What does this mean for study teams? When does this start? May 1st for all new studies Will this slow down the current start-up process/time? Parallel Processing – submit early! What studies have to be submitted? All studies involving human subjects How much does this cost? $2,000 charged to corporate sponsors only

How to Create a RMID 1. Search for existing RMID records 2. Create new RMID record RMID website: rmid.musc.edu RMID information website: horseshoe.musc.edu/research/rmid

Study Billing Plan Signoff PRA Process at a Glance Comprehensive review of study to ensure institutional and billing compliance and improve trial performance Initiate PRA Review Study Packet Build Study Calendar Study Team Consult Coverage Analysis Study Billing Plan Signoff Order Set Approval Final OCR Approval Study Activation Discuss the Study Billing Plan

How to Initiate a PRA Request PRA in SPARCRequest©️ https://sparc.musc.edu

Review Study Packet Study Packet MUST Include: If Applicable, Should Include: Protocol Contract Template Budget Template Informed Consent Template(s) IND/IDE Letter (if applicable) Manuals Lab Pharmacy Imaging Other Certificate of Confidentiality Investigator Brochure All study documents must be consistent Clinical Research Billing risk – billing for services promised for free in the ICF

Informed Consent Example

Informed Consent Example The ICF promises the participant that all study related procedures will be paid for by the research study. However, the budget states that some lab tests and the office visit should be billed as standard of care. ALL procedures must be provided free of charge to the participant.

Study Billing Plan Signoff What is a study billing plan? Defines which services should be ordered and at what time point Indicates who should be billed for each service participant/insurance vs. research study Who should review the study billing plan? OCR Representative Principal Investigator Study Delegate usually coordinator or grants administrator

Study Billing Plan Signoff What should be reviewed? MUSC Health billable services Services that should be included in the order set Appropriate payer for each service

Take Away Points May 1st for all new studies involving human subjects Submit study as early as possible $2,000 charged to corporate sponsors only

Questions and Discussion Office of Clinical Research (OCR) Email Address: musc-ocr@musc.edu Phone Number: (843) 792-7900 Address: Roper Medical Office Building, Suite 170 Web Address: musc.edu/research/ocr/

Recent Notices NOT-OD-17-049 Interim Guidance on Salary Limitation for Grants and Cooperative Agreements FY2017 NIH salary cap is $187,000 Effective January 8, 2017 Suggest using February 1st, 2017 as the earliest start date (easier math) for any changes provided the necessary funds are available. No additional funds will be provided by NIH. Use the new salary cap maximum for all future NIH proposals. Additional guidance from NIH is expected when the federal budget is enacted (operating under a continuing resolution).

Recent Notices NOT-OD-17-050 Reporting Preprints and Other Interim Research Products  Interim Research Products are complete, public research products that are not final (e.g. preprints and preregistered protocols). Effective for applications submitted for the May 25, 2017 due date and thereafter, and for RPPRs submitted on or after May 25, 2017. May be cited anywhere other research products are cited in applications, proposals and reports.

Recent Notices NOT-OD-17-050 (continued) Notes: Awardees are not required to create interim research products through their NIH award. Applicants are not required to cite interim research products as part of their grant applications. Since preprints are not published in peer-reviewed journals, they do not fall under the NIH public access policy. This guide notice does not apply to clinical trial registration.  See ClinicalTrials.gov about registration of clinical trial protocols.

Recent Notices NOT-OD-17-057 Guidance for Adjustments to Appointment Records in xTrain to Reflect Stipend Level Increases for Postdoctoral Trainees on Institutional Ruth L. Kirschstein National Research Service Awards (NRSA) Applies to T32, T35, T90, TL1 Provides the process for amending a stipend within xTrain when the training grant received supplemental funding in response to NOT-OD-17-002 Per NOT-OD-17-002, these supplemental applications must be submitted by June 30, 2017. No additional funds may be expended on behalf of trainees identified within a supplemental request until an amended appointment has been submitted and accepted in xTrain. For additional information see: xTrain Appointment, Re-Appointment, and Amendment Quick Reference Guide for Institution Users.

Reminder/Update Quick Review of NIH’s changes related to Clinical Trial submissions NOT-OD-15-015 NIH defines “clinical trial” “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” NOT-OD-16-147 NIH will require all applications involving one or more “clinical trials” must be submitted through a Funding Opportunity Announcement (FOA) No longer will NIH accept clinical trial applications through “parent” FOA announcements or any FOA not specifically designed to accept clinical trials

Reminder/Update Quick Review of NIH’s changes related to Clinical Trial submissions (continued) NOT-OD-17-043 Outlines NIH’s evolving plans in this area Spring 2017 – NIH getting new “PHS Human Subjects and Clinical Trials Information” form approved by OMB Fall 2017 – Expire existing clinical trial FOAs by January 24th, 2018 and Issue new clinical trial FOAs with new forms, instructions etc. MORE information from NIH to follow leading to these important changes NIH Clinical Research Policy - Clinical Trials NIH’s Office of Science Policy: Clinical Trials site Useful reference information for clinical research NOTE: Effective January 25, 2018, all grant applications with plans to conduct clinical trials must be submitted in response to an FOA which specifically states that clinical trials are allowed. After that date, applications planning a clinical trial that are submitted to a non-clinical trial FOA will be returned without review.

Final Thoughts Any Announcements? Questions or Comments? PLEASE complete a survey & THANK YOU Next Research Administration Information Session: May 17th, 2017 @ 11:00 IOP Auditorium