1 / 12

CENTER FOR CLINICAL TRIALS AND INDUSTRY RELATIONS

CENTER FOR CLINICAL TRIALS AND INDUSTRY RELATIONS. Patrice Holtz, RN MBA Director October 12, 2006. OVERVIEW. Current CCTIR Services Key FY 07 Goals and Objectives Contact Information. Current Services. Contracting Negotiate and finalize all industry sponsored clinical trial agreements

keran
Download Presentation

CENTER FOR CLINICAL TRIALS AND INDUSTRY RELATIONS

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CENTER FOR CLINICAL TRIALS AND INDUSTRY RELATIONS Patrice Holtz, RN MBA Director October 12, 2006

  2. OVERVIEW • Current CCTIR Services • Key FY 07 Goals and Objectives • Contact Information

  3. Current Services • Contracting • Negotiate and finalize all industry sponsored clinical trial agreements • Support Services • Provide clinical research coordinator support to SOM investigators • Education • Specialized clinical research training and education programs

  4. Key FY 07 Goals & Objectives 1.Align CCTIR’s infrastructure and capabilities for the Clinical & Translational Science Award (CTSA) application. 2.Establish and implement a research billing compliance program.

  5. 1. CTSA • NIH funded Roadmap Initiative • Purpose is to establish an assembly of institutional academic homes for the conduct of clinical and translational research • Will concentrate research resources in one organizational structure

  6. CTSA cont’ CCTIR will serve as a core for an Institute for Clinical and Translational Research • GCRC • Industry sponsored research will be integrated • Federal Government, Industry, and UMB funding

  7. CTSA cont’ • CCTIR will: • Act as port of entry for all clinical & translational research • Develop core research functional areas • Create a Research Advisory Board • Market SOM investigators to industry

  8. CTSA cont’ CCTIR will: • Establish collaborations with BioPark tenants • Establish new partnerships with community • Relocate to include office and ambulatory clinical research space (under discussion)

  9. 2. Research Billing Compliance • Why Billing Compliance -Medicare “double billing” has been the focus of OIG/DOJ investigations/settlements. • What Is Billing Compliance -Identifying clinical trial services that cannot be billed to third-party payors. -Ensuring processes to bill third-party payors are in place so that research services billed comply with billing rules.

  10. Research Billing Compliance Cont’ • SOM’s CCTIR Billing Compliance Program • Analysis of Medicare regulations for the research services • Establish designation of services as research v standard of care • Develop clinical trial budget in collaboration with study team and department administrator • Communicate the results to UMMS and PA’s

  11. Research Billing Compliance Cont’ • SOM’s CCTIR Billing Compliance Program • Education roll-out program in October 06 • Implementation in FY 06-07

  12. CCTIR Contact Information • Patrice Holtz RN MBA Director pholtz@som.umaryland.edu • Susan Hines RN CRNP Deputy Director shines@som.umaryland.edu • Diane Pfeifer RN BA Research Compliance Manager dpfeifer@som.umaryland.edu • Timothy Gilbert, MD Medical Director tgilbert@anes.umm.edu

More Related