Good clinical practice

Good Clinical Practice is an international ethical and scientific quality standard for the design, conduct and record of research involving people.

Compliance with the 13 principles of Good Clinical Practice provides public assurance that the rights, safety and well-being of research subjects are protected and respected, in line with the principles enunciated in the Declaration of Helsinki and other internationally recognised ethical guidelines. It also ensures the integrity of research data.

With the introduction of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU Directive on good clinical practice, compliance with Good Clinical Practice is now a legal obligation in the UK and Europe for all trials of investigational medicinal products.

Researchers involved in studies within this category are also strongly advised to familiarise themselves with, and implement, the Good Clinical Practice principles.

The Department of Health's Research Governance Framework for Health and Social Care (version 2, April 2005), also sets standards in health research in the UK.

Training in good clinical practice

It is CPFT policy that all staff working on clinical trials should undertake good clinical practice training every two years.

If you would like to undertake a course in good clinical practice courses are on offer at Addenbrooke's Hospital for a cost of £60. Please visit the Addenbrooke's website or contact Sylvie Robinson for more information.

The page was last updated on 27 March 2018 by aient.

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Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House, Fulbourn Hospital
Cambridge, CB21 5EF

T 01223 219400 (open 8:30am to 5pm)
F 01480 398501

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