IPHA model Clinical Trial Agreement
On 2 November 2021, the Irish Pharmaceutical Healthcare Association (“IPHA”), which represents the international originator biopharmaceutical industry in Ireland, published the initial draft of a model Clinical Trial Agreement (“CTA”) for use between clinical trial sites and sponsors in Ireland.
A draft of the CTA is available on the IPHA website. While the use of standardised CTAs is commonplace in other jurisdictions, it is the first time a model CTA has been published by an industry body in Ireland. IPHA’s aim in publishing the model CTA is to accelerate the contractual negotiation process and reduce the divergence between CTAs used by IPHA Member Companies and industry generally. Following some feedback an updated version was published on 2 December 2021.
If you would like to know more about the legal, regulatory and contractual aspects of clinical trials in Ireland, please contact Colin Kavanagh or Bridget McGrath.
