Regional template for clinical trial agreement (Oct. 2025)

Clinical trial agreements are legally binding contracts that establish the rights and obligations of the parties involved in a clinical trial, as well as the administrative and financial aspects related to its conduct. This document proposes a regional template for clinical trial agreements that sets out the basic clauses that should be included and harmonizes their essential content. It is intended to guide research institutions, sponsors, and investigators on key legal aspects of drafting and negotiating these agreements -- including aspects related to clinical trial insurance policies -- in order to streamline the processes required for initiating clinical trials and to hel ensure that they are conducted in line with current international ethical and regulatory standards. This template also seeks to strengthen governance and legal certainty in the conduct of clinical trials.