Investigator-Initiated Clinical Trial Agreement (Pro-Institution) | Practical Law

Investigator-Initiated Clinical Trial Agreement (Pro-Institution) | Practical Law

An agreement between two parties—typically a pharmaceutical or biotechnology company and a research institution or an individual clinical investigator—to support a human-subject medical research study concerning a drug or biologic, where the investigator plans, designs, conducts, and monitors the study at a research institution. This sample agreement contains provisions that are common in negotiated investigator-initiated trial (IIT) agreements, including terms addressing the clinical investigation's scope and the parties' responsibilities, compensation, compliance obligations, and rights and responsibilities concerning confidentiality, intellectual property ownership, and publication. This Standard Document is drafted in favor of the research institution but aims to be reasonable and consistent with standard industry practices. This Standard Document has integrated notes with important explanations and drafting and negotiating tips.

Investigator-Initiated Clinical Trial Agreement (Pro-Institution)

Practical Law Standard Document w-012-9280 (Approx. 24 pages)

Investigator-Initiated Clinical Trial Agreement (Pro-Institution)

by Practical Law Health Care
MaintainedUSA (National/Federal)
An agreement between two parties—typically a pharmaceutical or biotechnology company and a research institution or an individual clinical investigator—to support a human-subject medical research study concerning a drug or biologic, where the investigator plans, designs, conducts, and monitors the study at a research institution. This sample agreement contains provisions that are common in negotiated investigator-initiated trial (IIT) agreements, including terms addressing the clinical investigation's scope and the parties' responsibilities, compensation, compliance obligations, and rights and responsibilities concerning confidentiality, intellectual property ownership, and publication. This Standard Document is drafted in favor of the research institution but aims to be reasonable and consistent with standard industry practices. This Standard Document has integrated notes with important explanations and drafting and negotiating tips.