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

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

3. Office of Clinical Research
(OCR)

4. OCR Team

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

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

7. 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

8. 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

9. 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

10. How to Initiate a PRA Request PRA in SPARCRequest©️

11. 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

12. Informed Consent Example

13. 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.

14. 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

15. 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

16. 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

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

18. 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).

19. 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.

20. 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.

21. 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
Per NOT-OD , 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.

22. Reminder/Update
Quick Review of NIH’s changes related to Clinical Trial submissions
NOT-OD
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
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

23. Reminder/Update
Quick Review of NIH’s changes related to Clinical Trial submissions (continued)
NOT-OD
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.

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