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.
- 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
- Go from study protocols to successful study budgets: Plan for protocol amendments and procedure changes; financial checks and balances
- 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
- Clinical Research Coordinators
- Research Nurses
- Sponsor Representatives working with sites on study start-up
Lily Romero, P.A., C.C.R.C.
Click here for complete trainer biographies
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-11-010-L01-P. Released: 3/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.