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Negotiating a Contract

  • Cara East
Chapter

Abstract

The purpose of the clinical trial agreement (CTA) or contract is to set forth and manage the responsibilities and relationships between the sponsor, site, and/or the institution for the conduct of the clinical research trial. Responsibilities of the site include maintaining staff certifications and documentation, agreeing to follow the details of the protocol, obtaining appropriate subject consent, and providing all needed documents to the institutional review boards (IRB). The contract sets out the specifics of the compensation and schedule of payments. Other clauses address the investigational product, use of equipment, and audit procedures.

Keywords

Contact Master agreement Unlawful inducements Kickback Protocol Hold back Physician payments sunshine act Inclusion criteria Exclusion criteria Investigational product Audit Confidentiality Termination Indemnification 

References

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    Purner M. Nicholas R. Side-stepping the five most common FDA compliance pitfalls. Sep 27, 2003. http://www.hepro.com/itom-35000-1303/sidessteppins-the-five-most-common-FDA-compliance-pitfalls.html.
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    S. 301 (111th): Physician Payments Sunshine Act of 2009. Jan 22, 2009. https://www.govtrack.US/congress/bills/111/s301/text.
  4. 4.
    Open Payments – Centers For Medicare and Medicaid Services. June 15, 2018. https://www.cms.gov/OpenPayments/About/Resources.html.

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Cara East
    • 1
  1. 1.Baylor Soltero CV ResearchBaylor University Medical CenterDallasUSA

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