Contracts

Contract Templates 

HSE-approved Clinical Trial Agreement Templates

The Health Service Executive (HSE) has partnered with the Irish Pharmaceutical Healthcare Association (PHA) and leading commercial contract research organizations to create two pre-approved clinical trial agreement templates. These templates will improve clinical trial timelines and decrease cost and effort for all parties involved. Their use is mandatory for all HSE hospitals and highly recommended for all other hospitals, whether public or private

Bipartite-Model-Clinical-Trial-Agreement-(Bipartite-Commercial-Sponsor-and-Hospital) Version 2.0

This Clinical Trial Agreement (CTA) template is suitable for bipartite engagements involving a Commercial Sponsor and a Hospital. This model CTA was updated in 2024 to incorporate improvements, and it is effective and mandatory for all HSE Hospitals from 23.08.24. However, where negotiations have commenced, the CTA that is already the subject of the negotiations may continue to be used in the clinical trial. 

Tripartite Model Clinical Trial Agreement (Tripartite, Commercial Sponsor, Clinical Research Organisation and Hospital) – Version 1

This CTA template is suitable for tripartite engagements involving a Commercial Sponsor, a Commercial Contract Research Organisation, and a Hospital.

Clinical Indemnity Scheme Cover

In Ireland, clinical indemnity for clinical research is primarily managed through the Clinical Indemnity Scheme (CIS), operated by the State Claims Agency (SCA). This scheme provides indemnity for personal injury risks and associated liabilities arising from negligent acts or omissions during the provision of professional medical services by Delegated State Authorities (DSAs), such as the Health Service Executive (HSE) and other voluntary health and social care organizations:  

State Indemnity Guidance Document

This guidance sets out the indemnity and insurance arrangements for clinical trials health research conducted between State Authority healthcare enterprises and academic institutions. This updated guidance (published May 2022) replaces earlier versions of State Indemnity Guidance 10.

Clinical Trial Indemnity Form

This pro-forma for clinical trial indemnity is designed to assist State Authorities involved in clinical trials. This document should not be edited from its current format.