GDC Issues Guidance On Clinical Trials, UK

Main Category: Clinical Trials / Drug Trials
Also Included In: Dentistry
Article Date: 05 Dec 2007 - 3:00 PDT

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The GDC has issued guidance to all registrants associated with, undertaking or involved in clinical trials and research.

As set out in our Standards for dental professionals guidance, this involves:

- putting the patients' interests first;
- finding out about laws and regulations which may affect your work;
- finding out about current best practice;
- acting honestly and fairly; and
- making sure patients are able to claim compensation.

This means that it is your responsibility to be aware of any legislation relating to clinical trials and to seek approval from the local Ethics Committee where required. It is also important to check with your defence organisation before undertaking this kind of work.

Further information and advice is available via the GDC 'Standards Guidance' on our website, www.gdc-uk.org or you can visit the Medicines and Healthcare products Regulatory Agency's website www.mhra.gov.uk, to access the following documents:

- EU Clinical Trial Directive 2001/20/EC
- EU Directive on Good Clinical Practice 2005/28/EC
- Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) (as amended)
- Practice Guidance on Pharmacy Services for Clinical Trials, RPSGB and Institute of Clinical Research, June 2005
- Research Governance in Health and Social Care (Department of Health), NHS permission for R&D involving NHS patients, February 2004
- Guidance on Good Clinical Practice and Clinical Trials in the NHS, December 1999
- Good Research Practice, Medical Research Council, September 2005
- Description of the Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines and Healthcare products Regulatory Agency

The current legislation relating to clinical trials in the UK is the Medicines for Human Use (Clinical Trials) Regulations 2004, (amended 2006). These Regulations include a requirement to follow the conditions and principles of the EU Directive on Good Clinical Practice.

General Dental Council

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