Clinical trials for medicines: Good clinical practice inspections

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. Information relating to good clinical practice (GCP) inspections. Get emails about this page Print this page The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has produced guidance on Good Clinical Practice (ICH E6 (R3). 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: To support compliance with GCP, the MHRA: You must notify us of serious breaches of GCP or the trial protocol. See Guidance for the notification of serious breaches of GCP or the trial protocol . See the annual summary of MHRA GCP referrals . The majority of MHRA GCP inspections are carried out under the risk-based compliance programme. These can be either systems-based or trial specific. GCP systems inspections examine the systems used by an organisation to conduct clinical trial research. The inspectors will select a number of clinical trials to examine how the organisation’s trial procedures are applied. 1 or 2 investigator sites involved in the selected trials may also be inspected. Trial-specific GCP inspections assess an individual clinical trial and any organisation involved in the trial may take place. These may be risk-based routine inspections or concern a trial that has been submitted as part of an application for a marketing authorisation. Additionally, phase I units that are part of the phase I accreditation scheme are regularly inspected to assess compliance with the requirements of the scheme. Inspections may also be conducted to assess trial conduct and compliance with GCP and regulatory requirements. The risk-based inspection programme uses information available to the MHRA to determine an organisation’s risk. This information includes: Routine GCP inspections are conducted as per the diagram below, and more detail is provided in the sections below for each step. This figure shows the typical steps for planning, conducting, and reporting an inspection, though the order may vary. An organisation may be contacted to arrange an inspection if we suspect the law has been broken. This information might come from: In rare circumstances, we may give little or no notice of these inspections. We will notify you if your organisation is being considered for inspection, unless the inspection is to be conducted without notice. The notification will include a request for information in the form of a GCP inspection dossier and a clinical trials spreadsheet, which must be provided within 30 days. We will use the information provided to assess your organisation’s clinical trial activities, determine whether an inspection is required and, where appropriate, identify the areas to be examined and define the scope of the inspection. If you are asked to provide a dossier, you should use the following templates. Standard GCP dossier: GCP inspection dossier template ( MS Word Document , 153 KB ) GCP inspec