Developing and Negotiating Research Site Clinical Study Budgets and Contracts May 2019

May 30, 2019
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Course Description

Negotiating study contracts and budgets is critical for the future success of the clinical research site. This web seminar provides strategic skills and best practices for contract negotiations and budget development. Learners will also review and practice the art of negotiation.

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Learning Objectives

  • Prepare for negotiations: Define steps in the negotiation process; integrate strategies for effective negotiating; review success factors and risks in negotiations; discuss ethical considerations
  • Review industry study start-up basic contract content: Discuss state law, institutional vs. sponsor required language; “boilerplate” terms; indemnification; other agreements including data use, confidentiality, HIPAA, master agreements
  • Develop study budget presentations: Based on objective market data; subject vs. visit based
  • Assess protocol feasibility and resource needs: Look for hidden costs; study start-up to final query resolution
  • Translate information in a study protocol to successful study budgets: Plan for protocol amendments and procedure changes; financial checks and balances

Who Should Attend

  • Research Site Representatives that have some direct and/or indirect responsibility in contract and budget negotiations
  • Project Managers
  • Site Managers
  • Contracts and Budget Department Representatives
  • Clinical Research Coordinators
  • Research Nurses
  • Investigators
  • Sponsor Representatives working with sites on study start-up

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.