Clinical site agreement template (16.4, V2)

This deliverable is an outcome of Task 16.5 (2B.3.5) – Harmonisation of the site agreement contract.
The aim is to generate an EU template for clinical site agreement (“EU CSA”), accounting for national specificities, and which is meant to be used in the context of EU multi-country clinical trials to ease and speed up the agreement negotiation processes.
This type of agreement is usually established between the Sponsor of a Clinical trial and the clinical site where the investigation takes place (typically, the hospital or any premises in which the Clinical trial will be conducted) prior to the start of the clinical trial.
As per the ICH (global ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials), Article 5.1.4., “Agreements, made by the sponsor with the investigator/institution and any other parties involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement”. In general, the CSA defines the parties' responsibilities, access to study records, compliance with laws, compensation, confidentiality, intellectual property ownership, publication rights, and indemnification.
Several countries have developed templates for Clinical site agreements (see Survey’ Results below) but to the best of our knowledge, none of them is tailored specifically for EU multinational Clinical trials.
This Deliverable describes the methodology behind the development of the template, aiming at addressing challenges such as legal compliance, negotiation complexities, and national variations. The document should improve efficiency, reduce administrative burden, and ensure compliance with applicable EU regulations. Ultimately, this template will foster better collaboration across member states for Clinical trials.

Note: The development of this deliverable also involved consultation with external experts. For reasons of confidentiality, the full list of contributors involved in its drafting and review will be published once their consent to the public disclosure of their names and affiliations has been obtained