Clinical Trial Agreement

When is a CTA required:

A CTA is requried for all clinical trials at LSUHSC-S in which a private industry sponsor is providing monetary CTA.jpgor material support. A completed CTA is required before any clinical trial supported by a sponsor can begin.

Terms of the CTA:

The terms and conditions of a Clinical Trial Agreement (CTA) are negotiated in accordance with LSU policy. The Contracts Office will work with the sponsor to revise the original draft of the agreement until it is acceptable to both parties.

Negotiated Issues:

Among the many issues commonly negotiated by the Contracts Office are:
  • Publication Rights
  • Indemnification
  • Subject Injury
  • Insurance
  • Intellectual Property and Invention Rights
  • Publicity and Use of Name
  • Study Conduct
  • Termination and Survival
  • Governing Law, Jurisdiction & Arbitration
  • AAHRPP and Travel Language
  • Budget and Payment Terms
The Contracts Office may negotiate many other terms in a CTA if necessary for the conduct of a particular clinical trial.