Clinical Research Updates and Administrative Fee Changes
This update covers significant changes in clinical trial administrative fees, aiming to reduce burdens on the research community. The new fee structure includes a flat fee for new studies and additional charges for subject enrollment during IRB renewal. Furthermore, a new coverage analysis process has been implemented for all studies submitted after a certain date. These changes are expected to impact industry-sponsored clinical trials meeting specific criteria.
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Agenda Reducing Administrative Burden - Administrative Fees Billing Coverage Analysis Research Billing Review DocuSign eConsent Advarra Electronic Data Capture Subject Injury language in the ICF OnCore Updates
Clinical Trial Administrative Fees Current Burden on research community to include in study budget Burden on administrative offices to invoice Current Fees UNC IRB fee - $3000 UNC IRB renewal fee - $750 IRB Prep fee - $1000 Contracting fee - $1500 BCA fee - $2000 QA fee - $2000
New Clinical Trial Administrative Fees With 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.
New Clinical Trial Administrative Fees 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.
New Coverage Analysis process For 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 OnCore The OCT Team will meet with the PI and study team before finalizing BCA Budget to be developed using the BCA Budget negotiations to still be conducted by the study teams PI will still need to certify/approve final BCA
Centralized Coverage Analysis and Research Charge Review Study Team Begin enrolling New Study CRU OCT Notified via CTMS (OnCore or CRMS) Study Team completes feasibility analysis and finalizes budget BCA Coordinator meets with Study Team Study Start up meeting Office of Clinical Epic Research Billing Calendar created Non-Oncology: OCT Oncology: LCCC built from BCA, protocol, FE CTA, IRB approved ICF Trials Institutional signoff in Epic BCA Coordinator Triages study Yes BCA Required Coverage Analysis OCT Billing Finalized budget reviewed by OCT BCA Team BCA Coordinator finalizes BCA BCA Created ClinicalTrial OCT assists study team with registration (Details yet to be determined) CT.Gov Registration required OCT- s.gov Yes OSR-Industry Contracting Office IPF or ALICE RRF Received Agreement negotiated Fully executed agreement - NOA
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.
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.
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.
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.
Please complete the Research Refresher Course in UNC Health LMS
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.edu Include the following in your request: IRB number CRMS number PI full name Protocol number Protocol title
Advarra EDC UNC 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.
DocuSign Available for all Human Subjects Research (HSR) needs Informed consent, contracts, regulatory documents Collaboration between OVCR and SOM CRSO Validated for FDA 21CFR11 Compliance UNC solution for electronic signatures for FDA regulated studies Pilot Phase Completed, Broad Usage Available 70 users included in pilot Opening to community this week (keep an eye on your email!)
