Agenda Reducing Administrative Burden Administrative Fees Billing Coverage Analysis Research Billing Review DocuSign eConsent Advarra Electronic Data Capture Subject Injury language in the ICF ID: 1043829
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1. Clinical Research Updates
2. AgendaReducing Administrative Burden - Administrative FeesBilling Coverage AnalysisResearch Billing ReviewDocuSign – eConsent Advarra Electronic Data CaptureSubject Injury language in the ICFOnCore Updates
3. Clinical Trial Administrative Fees – Current
4. New Clinical Trial Administrative FeesWith goal of reducing burden on the Clinical Research community a flat fee of $3,500 will be charged to any new study after July 1, 2021. In addition, a flat fee of $100/new subject enrolled at each annual IRB renewal.The department will be charged $3500 when PS ID is created. At the time of IRB renewal, the department will be charged $100 per new subject enrolled.It is expected that this cost will be passed onto the study sponsor.If the department chooses to negotiate a higher fee, the department may keep the difference. The new fee is applicable to all industry sponsored clinical trials that meet the following criteria:Must be interventional Have more than one study visit Surveys, observational or registry studies will be excluded.
5. New Clinical Trial Administrative Fees
6. New Coverage Analysis processFor all new studies submitted after April 11, 2021 the Office of Clinical Trials will complete the billing coverage analysis All new studies must be submitted via CRMS or OnCoreThe OCT Team will meet with the PI and study team before finalizing BCABudget to be developed using the BCABudget negotiations to still be conducted by the study teams PI will still need to certify/approve final BCA
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8. Standardized Research Billing Review As of April 11, 2021 research billing review is conducted by the UNC Health for Chapel Hill Research Study Teams. Standardized Research Billing Review is a holistic approach to the Research Billing process. This will include comprehensive review of all encounters for a patient active on a research study via a two-tier Research Billing Review process. A patient who is tagged in Epic as “In Screening,” “Enrolled,” or “Off-Treatment” is considered an active patient. All encounters will go through this process, not just the encounters that have been linked to the research study. Standardized Billing Review will improve accuracy and compliance with research billing procedures. This new operational process will also reduce administrative burden related to billing review for research teams.
9. What does this mean to the Research Team? Research Coordinators will be responsible for the following items to ensure a smooth transition to Standardized Research Billing Review process for all UNC sites: Link research encounters to the research study Maintain accurate and current Patient Research Study Statuses (aka Enrolled, Completed, etc.) Add and maintain Patient Timelines in Epic Utilize SmartText for research encounters The research study team will still be handling all invoice payments to UNC Health, if applicable to your team.
10. What if my research study will never generate a charge in Epic?Please reach out to the BCA Coordinator team or the ORSC Finance team (whichever is appropriate for your study team) with your IRB number. They will review the BCA and if it meets the appropriate criteria, a flag can be added to your study in Epic. This flag will allow the patients involved in this study to bypass Research Billing Review.
11. What if there is a discrepancy with a research patient’s bill? Please contact UNC Health Billing Customer Service at 1-800-594-8624 on behalf of the patient or ask the patient to call themselves. A formal review will be performed and corrections will be made if needed.
12. Please complete the Research Refresher Course in UNC Health LMS
13. Subject Injury Language The UNC IRB requires a memo from OCT approving subject injury language in the informed consent. Please submit a request to obtain the correct subject injury language to SIL@unc.eduInclude the following in your request:IRB numberCRMS numberPI full nameProtocol numberProtocol title
14. OnCore Updates
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18. Advarra EDCUNC needed a 21 CFR Part 11 compliant electronic data capture system. With the OnCore enterprise expansion Advarra EDC was purchased and licensed Currently available for use in Infectious Disease and Lineberger Comprehensive Cancer Center only We are working on the infrastructure to support a campus wide role out.
19. DocuSign Available for all Human Subjects Research (HSR) needs Informed consent, contracts, regulatory documentsCollaboration between OVCR and SOM CRSOValidated for FDA 21CFR11 Compliance UNC solution for electronic signatures for FDA regulated studiesPilot Phase Completed, Broad Usage Available70 users included in pilotOpening to community this week (keep an eye on your email!)
20. Questions?