1. Clinical Trial Administration Presented by: Jill Griffith and Shannon Condon

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

3. Clinical Trials

4. Clinical Trials-What are they? Interventional Study - Studies to determine whether a technology is safe and effective in humans 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. 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. 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.) Government Agencies (e.g. NIH) - (translational res.) Pharmaceutical Industry Pharmaceutical Industry Bio-Tech Companies Bio-Tech Companies Clinical Trials-Who can participate? Determined by inclusion / exclusion criteria Determined by inclusion / exclusion criteria Purpose – not to reject personally, but rather identify appropriate individuals and keep them safe. Purpose – not to reject personally, but rather identify appropriate individuals and keep them safe.

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

7. Clinical Trials.gov 2005 2005 International committee of Medical Journal Editors (ICMJE) mandated registration of clinical trials as a condition for accepting manuscripts for publication. International committee of Medical Journal Editors (ICMJE) mandated registration of clinical trials as a condition for accepting manuscripts for publication. 2007 2007 Food and Drug Administration Amendments Act of 2007 (US Public Law 110-85) Food and Drug Administration Amendments Act of 2007 (US Public Law 110-85) Expands requirements for clinical trial registration Expands requirements for clinical trial registration Trials must be registered before onset of enrollment 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 Compliance Oversight Divisional Approval Divisional Approval Departmental Approval Departmental Approval IRB Approval – Regular, Expedited, Exempt Review IRB Approval – Regular, Expedited, Exempt Review ORSP Approval ORSP Approval Departments and Centers Departments and Centers Leadership – Division Directors, Business Mgrs Leadership – Division Directors, Business Mgrs Personnel- PIs, Study Coordinators, Data Managers Personnel- PIs, Study Coordinators, Data Managers Facilities Facilities Pre & Post Award Management Pre & Post Award Management Data and Financial Systems Data and Financial Systems

11. Life Cycle of a Sponsored Project

12. Pre & Post Award Process

13. Role of the Grant Manager Department Grant Manager CommitteesGCAORSPIRB Study Coordinators PIsSponsor

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

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

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

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

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

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

20. Reporting Progress/Final Reporting to the Sponsor 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. 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. 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 Close out reporting, cooperative effort amongst PI, Grant Manger, ORSP and GCA

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

22. Any Questions?