Regulatory and governance advice

The regulatory and governance environment for clinical research in general, and clinical trials in particular, is complex. Researchers need to understand and comply with a wide range of legal requirements, most importantly the EU Clinical Trials Directive as translated into UK law, but also the NHS Research Governance Framework, the Data Protection Act and associated confidentiality requirements.

The NIHR CRN CC Regulatory and Governance team has been established to provide support and guidance in regulatory and governance issues to staff working on NIHR CRN CC studies, to help facilitate high quality clinical research.  The team contributes to the coordination of The UKCRC Regulatory and Governance (R&G) Advice Service which is a UK-wide resource for those involved in health research (including non-portfolio studies).

NIHR CRN CC aims to:

• develop clear national approaches to the implementation of regulatory and governance requirements
• act as a central source for advice, support and guidance
• promote models and examples of best practice, to streamline the clinical research process while ensuring the rights, dignity and safety of patients are protected.

GMP - Annex 13 Revision
The long awaited revision to Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, was adopted by the Commission on 31st January 2010, published on 3rd February 2010 and comes into operation on 31st July 2010.

Updated Research in the NHS
The Research in the NHS: HR Good Practice Resource Pack has been updated. The Resource Pack sets out guidance and good practice standards (including the Research Passport system) to streamline the issuing of honorary research contracts (HRCs) and letters of access (LoAs), and enable NHS organisations to be confident that substantive employers have undertaken the appropriate pre-engagement checks for researchers.