The model Clinical Trial Agreement (“mCTA”) for tripartite clinical trials is available on the HSE website and is now mandatory. It takes effect from 20 May 2024 for tripartite engagements involving a commercial sponsor, a contract research organisation and a hospital(s). Standardised CTAs are widely used in other jurisdictions. This follows on from the bipartite CTA, which came into effect on 11 November 2022. The mCTA for tripartite clinical trials seeks to reduce delays for hospitals, lower costs for hospitals and businesses, increase efficiencies, allow more trials to begin on time, and, most importantly, improve patient outcomes.

For further information, please contact Colin Kavanagh, Bridget Clinton or Robert Byrne.