GovWire

Overview

Good clinical practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.

Organisations that may have to comply with GCP include:

• pharmaceutical companies
• contract research organisations
• universities
• NHS hospitals
• charities
• GP practices
• laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories)

Guidance on good clinical practice has been produced by the International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).

You can also get more information about GCP in the Good Clinical Practice Guide, produced by MHRA.

To ensure compliance with GCP, MHRA:

• asks trial sites to notify them of serious breaches
• carries out inspections of trial sites where serious breaches are reported
• carries out inspections of trial sites that sponsor clinical trials, mostly based on a risk assessment
• carries out inspections of sites when companies apply for marketing authorisations

Report a serious breach

You must notify MHRA of serious breaches of GCP or the trial protocol. See Guidance for the notification of serious breaches of GCP or the trial protocol (PDF, 221 KB, 12 pages).

See the annual summary of MHRA GCP referrals.

Triggered inspections for serious breaches

MHRA may contact you to arrange an inspection if they suspect the law has been broken. This information might come from:

• a serious breach notification
• a whistleblower
• other MHRA departments
• the health research authority (HRA)

In rare circumstances, MHRA may give little or no notice of these inspections.

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.

GCP systems inspections examine the systems used by your organisation to conduct clinical trial research. The inspectors will select a number of your clinical trials to examine how your organisations trial procedures are applied. One or two investigator sites involved in the selected trials may also be inspected.

Trial-specific GCP inspections assess clinical trials that have been completed and reported.

Currently phase I units that are part of the phase I accreditation scheme are not part of the risk-based programme but they are inspected every 2-3 years.

The risk-based inspection programme uses information available to MHRA to determine an organisations risk. This information includes:

• internal information about previous inspection history
• organisational changes
• intelligence from external sources

Each organisation is risk assessed and inspections are prioritised for the organisations considered to be the highest risk.

However, a small number of the organisations in the medium and low-risk categories will be randomly selected for routine risk-based inspections.

Routine GCP inspections are conducted as per the flowchart, and more detail is provided in the sections below for each step. See flowchart of the inspection process (PDF, 92.8 KB, 1 page).

Pre-inspection documentation

You will be notified if your organisation is chosen for inspection under the routine risk-based inspection programme.

The notification includes a request for information, in the form of a GCP inspection dossier and a clinical trials spreadsheet to MHRA within 30 days.

This dossier should include:

• a list of clinical trials
• organisation charts
• standard operating procedure (SOP) lists
• contact details
• overview of facilities
• service providers
• clinical trials activities

Use the GCP inspection dossier template (MS Word Document, 147 KB) and the GCP inspection dossier clinical trial spreadsheet (MS Excel Spreadsheet, 83.6 KB) to help you prepare your dossier. Use the GCP inspection dossier checklist (MS Word Document, 182 KB) to ensure your dossier is complete.

MHRA will agree an inspection date and give you information on the inspection team and the practical logistical aspects of the inspection.

Occasionally, after reviewing the dossier, the lead inspector may decide not to proceed with the inspection.

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