Medicines and Healthcare products Regulatory Agency gov.uk

Clinical trials for medicines: Good clinical practice inspections

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December 18, 2014 00:00 Alert

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Information relating to good clinical practice (GCP) inspections.

Good clinical practice (GCP) is an ethical and scientific quality guideline concerning the design, conduct, analysis and reporting of clinical trials of medicines.

ICH E6 (R3) Good Clinical practice is composed of overarching principles, Annex 1 (interventional clinical trials), Annex 2 (additional considerations for non-traditional interventional clinical trials), Glossary and Appendices.

For more information on implementation of ICH E6 (R3) GCP in the UK see guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom and for UK specific annotations to ICH E6 (R3) see UK-specific annotations to ICH E6(R3) .

Organisations that have to comply with GCP as set out in the MHRA guidance above include:

organisations who provide services to undertake any function of the sponsor and investigator conducting clinical trials (e.g. contract research organisations, organisations who develop and maintain trial specific computerised systems)

laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories)

To support compliance with GCP, the MHRA:

requires organisations sponsoring clinical trials to notify them of serious breaches

may conduct triggered inspections of organisations where serious breaches are suspected

may conduct routine risk-based inspections of organisations that sponsor or conduct clinical trials

may conduct inspections of clinical trials, and associated activities, submitted in support of a marketing authorisation application

Inspections under the risk-based compliance programme

The majority of MHRA GCP inspections are carried out under the risk-based compliance programme. These can be either systems-based or trial specific.

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Organization: Medicines and Healthcare products Regulatory Agency — imported from official source
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