Competency Framework for Clinical Research Nurses 21 October 2011 Dr Leslie Gelling Reader in Research Ethics Faculty of Health and Social Care

First published in Dec Working Group meetings.

The Working Group: Deborah Beirne Sue Boase Anne Croudass Kate Craig Caroline Gunnell Eileen Dillon Anne Gordon Jayne Groves Rachel Hornabrook Caroline Humphreys Sara Jones Paul Maher Sandra Mulrennan Fiona O’Neill Chris Oxnard Helen Pidd Tom Quinn Martha Wrigley

First published in Dec Working Group meetings. National consultation in 2010.

Competency Framework i 1. To demonstrate understanding of the background, political influence and strategy regarding clinical research in the UK. 2. To work within, and adhere to, the requirements of research ethics, research governance and legislation: 2.1 Understands the role and remit of research ethics committees in the UK 2.2Contributes to the preparation of documentation and submissions of applications for ethical approval. 3. To understand, apply and promote the principles and practice of obtaining valid informed consent.

Competency Framework ii 4. To apply professional knowledge and skills to facilitate efficient, safe and participant focused clinical research: 4.1Contributes to the development of safe clinical research. 4.2Contributes to efficient use of resources. 4.3Contributes to the delivery of clinical research 4.4Contributes to the safe collection and storage of data and accurate completion of study documentation.

How to use the Framework: Complex role of Clinical Research Nurse (CRN). Flexibility – adapt for local use: - Skills and behaviours - Knowledge and understanding - Band examples - Additional reading, contextual information and websites

Thank you