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Clinical Trial Administration Presented by: Jill Griffith and Shannon Condon

Clinical Trial Administration Presented by: Jill Griffith and Shannon Condon. Presentation Overview: Synopsis of Clinical Trial Benefits & Importance of Clinical Trials Clinical Trials at MUSC, Environment and Life Cycle Role of Business and Grant Managers Open Discussion. Clinical Trials.

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Clinical Trial Administration Presented by: Jill Griffith and Shannon Condon

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  1. Clinical Trial AdministrationPresented by:Jill Griffith and Shannon Condon

  2. Presentation Overview: • Synopsis of Clinical Trial • Benefits & Importance of Clinical Trials • Clinical Trials at MUSC, Environment and Life Cycle • Role of Business and Grant Managers • Open Discussion

  3. Clinical Trials

  4. Clinical Trials-What are they? • Interventional Study - Studies to determine whether a technology is safe and effective in humans • Technology may be a diagnostic tool, a drug, a device, or a behavioral intervention. • Observational studies - Individuals are observed and their outcomes are measured by the investigators.

  5. Clinical Trials-Who sponsors them? • Government Agencies (e.g. NIH) - (translational res.) • Pharmaceutical Industry • Bio-Tech Companies ClinicalTrials-Who can participate? • Determined by inclusion / exclusion criteria • Purpose – not to reject personally, but rather identify appropriate individuals and keep them safe.

  6. Clinical Trials-Benefits • Advancement of knowledge • Contribute to medical research • Access to Therapies • Access to Network of Scientists • Source of Support • Residual Funds • Patient Compensation

  7. Clinical Trials.gov • 2005 • International committee of Medical Journal Editors (ICMJE) mandated registration of clinical trials as a condition for accepting manuscripts for publication. • 2007 • Food and Drug Administration Amendments Act of 2007 (US Public Law 110-85) • Expands requirements for clinical trial registration • Trials must be registered before onset of enrollment

  8. MUSC Corporate Awards per FY

  9. MUSC FY07 Research Expenses

  10. Clinical Trials- MUSC Environment • Compliance Oversight • Divisional Approval • Departmental Approval • IRB Approval – Regular, Expedited, Exempt Review • ORSP Approval • Departments and Centers • Leadership – Division Directors, Business Mgrs • Personnel- PIs, Study Coordinators, Data Managers • Facilities • Pre & Post Award Management • Data and Financial Systems

  11. Life Cycle of a Sponsored Project

  12. Pre & Post Award Process

  13. Role of the Grant Manager

  14. Role of Grant Manager • Provide support to Investigators to build infrastructure within their respective research programs and manage day to day operations. • Financial Management • Understand restrictions and allowances • Strengthen internal controls and demonstrate accountability • Provide leadership and guidance to investigators • Operations Management • Human Resources • Purchasing/Contracting • Space Allocation

  15. Keys to Success • Communication • Predicting the Flow of Income • Consistently Applying Practices and Policies • Meeting Financial and Effort Reporting Requirements in a timely fashion • Compliance

  16. Communication • Role of Study Coordinator • Protocoland clinical management • Role of Principal Investigator • Protocol, clinical, & financial management • What is the key to effective communication? • Trust • An understanding of each key person’s role • Creating an environment of communicating regularly and being a team player

  17. Predicting the Flow of Income • Understand payment terms on grants and contracts • Know benchmarks • Know payment schedule & payment amounts • Know common invoiceable items; i.e., advertising • Prompt payment of invoices • Slow receipt of income v. timely posting of expenses • Strategically planning for gaps in funding or cost over runs

  18. Consistency • Different clinical specialties • Different sponsors • Different protocols • Standardizing accounting procedures • Standardizing operating procedures • Creating a climate where the PI can trust that his grant manager will keep in order

  19. Reporting • Financial Reporting • Budget to Actual • Standard Data to provide PIs • Earned v Actual income • Actual expenses, per category • Outstanding commitments • Projected fund balance • Effort Reporting • Certifying on a quarterly basis how percentage of time (effort) was spent. • Determining whether actual distribution and payroll distribution match and how to handle variances.

  20. Reporting • Progress/Final Reporting to the Sponsor • Reporting to the sponsor annually on the progress of the research, and submitting final reports as required by the sponsor. • Meeting required deadlines of annual and final reporting are usually contingent upon additional funding. • Close out reporting, cooperative effort amongst PI, Grant Manger, ORSP and GCA

  21. Compliance • Rules and Regulations we must follow • A few examples: • Protection of Human Subjects • HIPPA • OMB Circulars • University Policies and Procedures

  22. Any Questions?

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