Welsh Government

Contracts

Many research studies involving human participants, tissue or data requires a clinical research agreement.

The introduction of Model Agreements for commercial and non-commercial research has greatly helped to reduce the time taken to negotiate clinical research contracts and there is a model agreement available for most types of clinical studies and medical device studies.

For more information contact: research-contracts@wales.nhs.uk

Model Agreements

In order for a research study to commence within an NHS site, an agreement needs to be in place.  Where this agreement needs to be a  formal site agreement, a set of model agreements have been developed and designed throughout the UK to assist and simplify this process which may be used.

Model Agreement for Non-Commercial Research in the Health Service 2008 (mNCA 2008) – This is intended for use for formalising relationships between the Non Commercial Sponsor and the site where the research is being conducted.

Model Clinical Trial Agreement 2018 (mCTA 2018) – This is intended for use for formalising a bipartite relationship between the Industry Sponsor and the NHS Organisation where the Clinical Trial is being conducted. 

Clinical Research Organisation Model Clinical Trial Agreement 2018 (CRO mCTA 2018) – This is intended for use for formalising a tripartite relationship between the Industry Sponsor, the CRO managing the Clinical Trial and the NHS Organisation where the Clinical Trial is being conducted. 

Model Clinical Investigation Agreement Wales 2014 (mCIA Wales 2014) – This is intended for use for formalising a bipartite relationship between the Industry Sponsor and the Welsh NHS Organisation where research involving a medical device is being conducted. 

Model Clinical Research Organisation Model Clinical Investigation Agreement Wales 2014 (CRO mCIA Wales 2014) – This is intended for use for formalising a tripartite relationship between the medical device Industry Sponsor, the CRO managing the Clinical Trial and the Welsh NHS Organisation where research involving a medical device is being conducted.

Primary Care Model Clinical Trial Agreement Wales 2013 – This is intended for use for formalising a bipartite relationship between the Industry Sponsor and Primary Care where the Clinical Trial is being conducted.