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.

http://www.ukcrc.org/wp-content/uploads/2014/03/mNCA_Guidance_FINAL_2008.pdf

http://www.ukcrc.org/wp-content/uploads/2014/03/mNCA_FINAL_2008.doc

Model Clinical Trial Agreement Wales 2011 (mCTA Wales 2011) – This is intended for use for formalising a bipartite relationship between the Industry Sponsor and the Welsh NHS Organisation where the Clinical Trial is being conducted. 

http://www.ukcrc.org/wp-content/uploads/2014/03/mCTA-Guidance-2011.pdf

http://www.ukcrc.org/wp-content/uploads/2014/03/mCTA-Wales-2011.doc

Clinical Research Organisation Model Clinical Trial Agreement Wales 2011 (CRO mCTA Wales 2011) – This is intended for use for formalising a tripartite relationship between the Industry Sponsor, the CRO manging the Clinical Trial and the Welsh NHS Organisation where the Clinical Trial is being conducted. 

http://www.ukcrc.org/wp-content/uploads/2014/03/mCTA-Guidance-20111.pdf

http://www.ukcrc.org/wp-content/uploads/2014/04/CRO-mCTA-Wales-2011.doc

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. 

http://www.ukcrc.org/wp-content/uploads/2014/05/Guidance-mCIA-2014.pdf

http://www.ukcrc.org/wp-content/uploads/2014/05/mCIA-Wales-2014.doc

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.

http://www.ukcrc.org/wp-content/uploads/2014/05/Guidance-CRO-mCIA-2014.pdf

http://www.ukcrc.org/wp-content/uploads/2014/05/CRO-mCIA-Wales-2014.doc

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.

http://www.ukcrc.org/wp-content/uploads/2014/05/Guidance-on-use-of-the-Primary-Care-mCTA-2013-131213-f.pdf

http://www.ukcrc.org/wp-content/uploads/2014/05/Primary-Care-mCTA-Wales-2013.doc