Developing and Negotiating Clinical Study Budgets March 2010

Course Description

Negotiating study contracts and budgets is critical for the future success of the clinical research site. This course provides strategic skills and best practices for contract negotiations and budget development. The course also reviews and practices the art of negotiation.



Learning Objectives

  • Prepare for Negotiations: Define steps in the negotiation process; integrate strategies for effective negotiating; review success factors & 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 & Resource Needs: Look for hidden costs; study start-up to final query resolution
  • Go From Study Protocols to Successful Study Budgets: Plan for protocol amendments & procedure changes; financial checks and balances

Who Should Attend

This course is designed for research site representatives that have some direct and/or indirect responsibility in contract and budget negotiations.

  • Site Managers/Project Managers
  • Contracts and Budget Department Representatives
  • CRCs/Research Nurses
  • Investigators
  • Sponsor Representatives working with sites on study start-up


Sandra “SAM” Sather, MS, BSN, CCRA, CCRC

Click here for complete trainer biographies

Course Length Time

3 hours; 9:00 a.m. - 12:00 p.m. Eastern

Course Dates

March 29, 2010

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471


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