Clinical Trial Agreements


An essential requirement of the Research Governance Framework is that clear written agreements are in place for all research involving external partners and that these detail each partner's responsibilities and rights. This is particularly important for clinical trials where agreements are put in place between all parties who have responsibilities and delegated duties for initiation, management, conduct and financing.
 

Non Commercial

Negotiation of contracts between Sponsors and the sites carrying out the research can lead to delays and variation. To simplify and standardise the process a model agreement ( Link opens in new windowmNCA) has been developed. This provides a template for documenting the relationship between and the responsibilities of the non-commercial sponsor(s) of a research study and the Health Service organisation where the study takes place. It is intended for use in non-commercial research studies carried out in Scotland, Wales and Northern Ireland . The mNCA ensures compliance with the applicable UK law and institutional arrangements. We recommend the use of this model Agreement wherever possible.

Enquiries regarding Clinical Trial Agreements can be made to Susan Ridge , Business Development Officer (s.ridge@nhs.net, tel 01224 553728).
 
 

Commercial

MARU, on behalf of NHS Grampian, has implemented both the model Clinical Trial Agreement (mCTA) and the Tripartite Model Clinical Trial Agreement for studies managed by Contract Research Organisations (CRO mCTA) as approved by the Department of Health and the Association of British Pharmaceutical Industry (ABPI) in 2006 and 2007, respectively.  It is intended for use in commercial research studies carried out in Scotland, Wales and Northern Ireland.
 
You can find copies of the mCTA and CRO mCTA on the Link opens in new windowUKCRC website. Note that NHS Grampian has its own Financial Arrangements under Appendix 5 of the mCTA and Appendix 6 of the CRO mCTA.
 
Enquiries regarding Clinical Trial Agreements for commercially sponsored studies can be made to Dr Alison Stewart, Commercial Research Manager (alison.stewart10@nhs.net, tel 01224 554958).