Research Governance

All EME funded research teams are expected to conduct their research in accordance with Good Clinical Practice. 

You can find information regarding the regulatory and governance environment for clinical research and trials on the resources page.

Research Governance Framework

The Research Governance Framework defines the principles of good research governance and is vital for ensuring that health research is conducted to high scientific and ethical standards. EME funded research must work within this framework.

Under the Research Governance Framework we are required to ensure that the research projects we fund establish a Trial Steering Committee (TSC), a Data Monitoring and Ethics Committee (DMEC) and appoint a sponsor. 

Trial Steering Committee guidelines (119kb)

Data Monitoring and Ethics Committee guidelines (114kb)

Sponsor

A sponsor is defined as an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial. Further details can be found at www.ct-toolkit.ac.uk/sponsorship.pdf (57kb)

Sponsors have responsibilities in the areas of:

• quality assurance (safe and worthwhile; ethical approval; quality research environment; necessary expertise and experience; trial registration);
• resources (to ensure the research will deliver: quality data; against the agreed protocol);
• agreements in place (on responsibilities; management; monitoring; intellectual property; compensation; dissemination);
• review (of safety and design);
• obtaining independent expert advice (for sponsor’s scientific judgements).

Trial Managers

All Projects are encouraged to appoint a dedicated Trial Manager. We have produced a  generic job description (116kb)  which you may find useful. Please let us know about any appointments you make.

All Trial Managers employed on NIHR trials are eligible for free membership to the NIHR Trial Managers Network (TMN), and are strongly encouraged to join.

The TMN is run by trial managers for trial managers and has been primarily developed to facilitate the sharing of expertise and knowledge, in order to implement best practice in the management of clinical trials. Further information including membership forms are available at www.tmn.ac.uk