The HSE, in partnership with the Irish Pharmaceutical Healthcare Association (IPHA) are delighted to announce the official launch of the Model Clinical Trial Agreement (CTA) for tripartite clinical trials that involve Contract Research Organisations (CROs). Marking International Clinical Trials Day, this significant development will improve the clinical trial landscape in Ireland further enabling patients to participate in cutting-edge health research. This Model CTA, agreed by both the HSE and the IPHA, is designed for use between the Site, the CROs and the Sponsor. Following extensive review by CROs, IPHA member companies, the HSE, and other dedicated stakeholders, this standardized document ensures fairness and balance. The introduction of a single standard clinical trial agreement for Ireland will reduce delays and costs for hospitals and companies, increase efficiencies, and enable timelier setup of trials in Ireland, thereby significantly improving patient health outcomes. Cllr Racheal Batten MA, LLB,Hdip,BL, APA, National Lead for Legal and Data Protection in Research, HSE R&D comments on this landmark agreement: “This model CTA is the result of a close collaboration between the HSE and the IPHA, and it could not have been achieved without the support of Hilda O'Keeffe of Comyn Kelleher Tobin LLP . We would like to thank all of the contributors, especially the State Claims Agency and the ongoing support from the Department of Health - Ireland who helped to develop this agreement, sharing in our dedication to improving clinical trial infrastructure and improving health outcomes in Ireland. Clear evidence shows that patient participation in clinical trials leads to substantial health improvements, and this agreement will enhance patient access to life-saving interventions.” Click here to download the Tripartite Model CTA: https://lnkd.in/erT4vmPa If you have any questions, please contact ResearchAndDevelopment@hse.ie
Thomas Costello
7mo
Positive move forward for patients and clinicians alike 👏🏻 well done all
Olga Cleary
7mo
Excellent work, well done to all the team involved Racheal!
HRB National Clinical Trials Office (NCTO) Health Research Board (HRB) UCC Research UCD Research Irish Research Council HRCI - Health Research Charities Ireland Cancer Trials Ireland UCD Clinical Research Centre ECRIN (European Clinical Research Infrastructure Network) Science Foundation Ireland