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JUMP DIRECTLY TO SLIDE Opening Introduction by Daniel Clauw (Director of CACR) --CORPORATE SPONSORS: WORKING WITH DRDA Today we'll touch on policies... Who to Call in the Brock Group A Plea From My Staff: Categorize the Activity Who Signs What at the University? If you need to get... What is a Non Disclosure Agreement Confidential Information: FOIA Sponsor Confidential Information: CRIA How Do I Process an NDA? What is a Clinical Trial (CT)? Who Does What to get a CT started? Audience Comment Audience Question Who are the Parties to these CTAs? What are the issues in CTA's? --PROPRIETARY INFORMATION, DATA, PUBLICATION Agreements Address Various Types of Information Confidential/Proprietary Information Regents' Policy on Research Grants... Standard Restrictions, Cont'd What Publication Terms Does the University prefer in CTAs? Types of Data: Case Report Forms (CRF's) HIPAA in Clinical Trials What is Protected Health Information Some PHI Authorization Requirements are of Particular... --INTELLECTUAL PROPERTY (IP): The BASICS IP Summary Intellectual Property Policy/Law What IP Terms does the University Prefer... Practical Concessions Regarding IP in Sponsor... IP: ABC, Inc., Viewpoint --COSTS, BUDGETS, PAYMENTS Clinical trial Budget Considerations Audience Question Payment Terms in CTAs Should Reflect the Budget... Payment of costs... DRDA Can Help --MATERIALS TRANSFER AGREEMENTS What is a Materials Transfer Agreement (MTA)? What is a Materials Transfer Form (MTF)? How Do I Process an MTA? Clarification --CONFLICT OF INTEREST Conflict of Interest Management Underlying Premise Financial Disclosures Disclosures to Sponsors Disclosure by Clinical Trial Sponsor to FDA University-wide Policy and Procedures for Dealing... It all starts with disclosure. Medical School Disclosure Some Conflicts of Interest have to Be Approved... Conflicts of Interest in Sponsored Reseach can arise... Avoiding Overlap is Critical Management plans Protect Basic Values of... --WHEN THINGS GO WRONG No $$$$ from Sponsor Breach of Contract by UM Proliferations of Laws and Regulations... What can you do to move CTA's Faster and make... Moving CTAs Faster, Cont'd HIPAA Questions Websites of Interest Audience Question 1 Audience Question 2 Audience Question 3 Audience Question 4 Audience Question 5 Audience Question 6 Audience Comment 7 End of Lecture        synchronize audio with current slide