1. CLINICAL RESEARCH STUDIES Janette Hannam, MS, CTRA Asst. Director for Research, OSP

2. WHY DO CLINICAL TRIALS? New patient treatments Further University research efforts Partnership with industry Increase research funding Opportunity for investigators to publish

3. Sources of Sponsored Research $353,908,822

4. How do I get started? Route COMPLETE proposal to: Human Investigations Committee (HIC) Office of Sponsored Programs(OSP) DO NOT need HIC approval prior to routing to OSP !!

5. WHAT DO I ROUTE? COMPLETE PROPOSAL consists of: –Sponsored Programs Approval Form(SPAF) –Protocol including informed consent and/ subject authorization –Budget –Clinical Trial Agreement –Name and phone numbers for company contacts

6. WHEN DO I ROUTE? YESTERDAY!! When ALL documents are received –The worse thing you can do is route an incomplete package

7. WHY DO I ROUTE? To insure that ALL University authorities are in agreement with protocol/research that is being proposed.

8. SPAF Sponsored Programs Approval Form Why do I need a SPAF?? –Indicates approval from: Supervisor Division Chief, if necessary Chair Dean, School of Medicine Office of Sponsored Programs

9. PROTOCOL Purpose –Allows those approving protocol/research to review what work is to be performed –Outlines specifically what will be done –Instructs all those working on project –Gives clinical contacts at company –Becomes document of record should litigation occur

10. BUDGET Indicates how research funding is to be allocated Gives Department and School benchmarks for internal budget projections Provides Office of Grants and Contracts guidelines on receipts and expenses Supports legal contract Shows indirect cost rate

11. Clinical Trial Agreement Creates legal document between Company and University Gives clear definitions as to what Company and University have agreed to Must be executed by University official(OSP)

12. Key Elements in CTA Recitals(who, what, when & where) Dates Dollars Indemnification Termination Confidentiality Publication Data Ownership License & Patents Legal Jurisdiction

13. What is OSP’s involvement? Negotiate language in clinical trial agreement with company Execute documents on behalf of University Insure HIC compliance Act as liaison between University, Company, other University offices Coordinate documents Complete award process(account number)

14. When can we see patients? All documents are signed OSP receives fully executed original clinical trial agreement HIC approval is obtained NOA is completed and sent to OGCA

15. When do I get an account number? All documents are signed OSP receives fully executed original clinical trial agreement HIC is approved Office of Grants and Contracts has given account number to OSP

16. When can I use the new account number? After OSP does Notice of Acceptance After OGCA inputs NOA information

17. Why can’t the investigator sign clinical trial agreement? Not authorized by University to enter into contracts on behalf of University Insures compliance to policy and procedures

18. QUESTIONS