Good Clinical Practice (GCP) inspections

Why we conduct GCP inspections

We conduct inspections (regulatory audits) of clinical trials to check if they are being conducted according to the requirements of Good Clinical Practice (GCP).

GCP is a set of internationally recognised ethical and scientific quality guidelines that must be followed when designing, conducting, recording and reporting on clinical trials.

If the GCP guidelines are followed, this gives us confidence that the rights, safety and well-being of people participating in the trial (known as trial participants) are protected, and that the results of clinical trials are reliable. For that reason, all clinical trials must be designed, conducted and reported according to the principles and requirements of GCP. In addition to GCP, we will also check that the trial is being performed according to any other applicable legislation and guidelines.

The aim of inspections is to check compliance. As part of this we may identify some practices or processes that are not in compliance. Where we identify these issues, we will expect the site or company to take action. This can include correcting any ongoing issues and/or taking steps to prevent the issue from happening again.

Types of GCP inspections

The GCP guideline outlines two key groups that are responsible for most activities relating to a clinical trial- the investigator and the sponsor.

• The investigator is the main person responsible for conducting the trial at an individual site. This is typically a medical doctor who is responsible for conducting the trial at a hospital or clinic.
• The sponsor is the company or organisation that is responsible for the overall trial, which may be conducted at one or multiple sites. This can include pharmaceutical companies, universities or other research institutions who decide to conduct the clinical trial.

The focus, or scope, of GCP inspections can differ depending on where the inspection is conducted.

Inspections may be study specific, and focus on reviewing GCP compliance of a single clinical trial, or they may be broader and look at the systems which support trials generally. Typically, investigator site inspections are study specific, while inspections of sponsors may be used to broadly review systems and processes they have in place to support multiple clinical trials.

Inspections may be carried out at any stage of a clinical trial, including ongoing or completed studies, and may be announced or unannounced. However, generally, we give notice to sites before conducting an inspection.

Selection of sites for inspection

Most of our inspections are performed as part of our national routine risk-based programme. This is where a sample of clinical trials and clinical trial sites are selected for inspection on an annual basis. Other inspections may be performed throughout the year in response to specific information that is received, which are known as 'for cause' or 'triggered' inspections.

Inspections may be performed at any site that is involved in a clinical trial, including:

• investigator sites (e.g. hospitals or clinics where the trial is conducted),
• clinical research facilities which support clinical trials at larger hospitals,
• offices of the clinical trial sponsor
• any other company or 'service provider' who may be contracted by the clinical trial sponsor.

A request to inspect a trial may also be received from the European Medicines Agency (EMA). If requested, we may conduct these inspections in collaboration with inspectors from other EU member states. This may involve inspection of sites internationally, and would typically include trial sites in countries outside of the EU.

Procedure for GCP inspections

The typical procedure for the conduct of routine national GCP inspections is outlined below. EMA requested inspections will follow a similar process, but are conducted according to different timelines.

You can find further information on GCP inspections in the guidance document below.

You can find more information on GCP on our Good Clinical Practice page.

You can find information relating to GCP topics of interest on our dedicated page. Each topic includes background information, links where you can find further information, and some useful guidance from our inspectors.