What is Good Clinical Practice (GCP) Training? Do I need it?

What is Good Clinical Practice (GCP)?

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard for designing, running, recording and reporting clinical research. Compliance provides public assurance that the rights, safety and wellbeing of research participants are protected, and that research data are reliable.

You will often see it written as ICH GCP, after the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the body that publishes the guideline. GCP training is the structured learning that shows you understand that standard and can apply it to your own work.

What changed for GCP in April 2026?

On 28 April 2026 the amended UK Clinical Trials Regulations came into force alongside the latest revision of the GCP guideline, ICH E6(R3). This was the largest change to UK clinical trials regulation in more than twenty years, and it matters for training.

Two points are worth knowing:

• The GCP principles are now a legal requirement. Regulation 28 of the amended regulations requires compliance with the ICH E6 GCP principles, rather than with the entirety of the guideline. Trials supporting a marketing authorisation application are expected to follow the full guideline.
• Proportionality is the organising idea. E6(R3) is built around risk and fitness for purpose. Sponsors and sites are expected to judge what a particular trial genuinely needs, rather than applying one fixed checklist to every study.

If you trained before 2026 your certificate has not been withdrawn, but the content you were taught has moved on. Most employers are now asking staff working on trials to complete refresher training covering E6(R3).

Do I actually need GCP training?

This is the question we are asked most, and the answer is more nuanced than many researchers are told.

If you work on a CTIMP, yes

Everyone involved in conducting a Clinical Trial of an Investigational Medicinal Product must be qualified by education, training and experience to perform their tasks. If you are delivering a CTIMP, you will be expected to hold current GCP certification.

If your study is not a CTIMP, probably not

A great deal of unnecessary GCP training gets done every year. The HRA, MHRA and the devolved administrations for Northern Ireland, Scotland and Wales have published a joint statement confirming that there is no legal requirement for research other than CTIMPs to be conducted in line with ICH GCP.

The same statement notes that researchers are sometimes required to complete GCP training inappropriately and disproportionately, either when they do not work on CTIMPs at all, or when their involvement in a trial is minimal and sits entirely within their existing professional expertise. If you are being asked to complete a full GCP course for an observational or qualitative dementia study, it is reasonable to ask your R&D office which requirement that is meeting.

If you are a PhD student or early career researcher

It depends on what you will be doing, not on your job title. Recruiting and consenting participants to a CTIMP, handling investigational medicinal products or collecting trial data all point towards needing it. Analysing an existing dataset, running interviews for a non-CTIMP study, or working on preclinical laboratory research generally do not.

Many supervisors and sponsors encourage GCP training anyway, because it teaches consent, documentation and data integrity properly. It is free, it is CPD accredited, and it is a useful line on your CV if you are moving towards clinical research delivery.

Does everyone need the same level of GCP training?

No. Training should be appropriate and proportionate to what you actually do on the study. Someone acting as a Principal Investigator needs a different depth of understanding to someone performing a single delegated task within their existing professional competence.

If you are a PI or site lead working out who on your team needs what, start from the delegation log. Decide which tasks are being delegated to whom, then ask whether those people have the training and experience for those specific tasks.

How often do I need to renew my GCP certificate?

There is no single legally fixed renewal period. Your employer or sponsor sets this through their own standard operating procedures, so the answer depends on where you work and what you work on.

As a rule of thumb, the NIHR recommends refresher training every two to three years to keep pace with best practice. Regulatory change matters too, and the April 2026 updates are exactly the kind of shift that should prompt a refresher regardless of when you last trained.

For a researcher’s view on whether all this refreshing is worthwhile, read Dr Emma Law on GCP refreshers.

What GCP training is available, and is it free?

The NIHR offers free GCP training to people supporting clinical research delivery in the NHS, UK universities and other publicly funded organisations in England. The current offer covers:

• GCP introduction, for staff new to research delivery
• GCP refresher, for experienced staff, including the E6(R3) updates
• GCP consolidation, a facilitated session building on the e-learning
• Informed consent courses, at a range of levels

All courses are CPD accredited. They are booked through NIHR Learn, which replaced the former CRN Learn platform. If you have not used it before, create an account using your work email address.

The courses focus on practical application, so that you know what to do differently when you get back to your workplace.

I am not based in England. Where do I go?

GCP training is organised nation by nation, although the underlying standard is the same across the UK:

• Scotland: NHS Research Scotland runs the national NRS GCP programme
• Wales: Health and Care Research Wales offers free introduction and refresher sessions
• Northern Ireland: training is coordinated through Health and Social Care R&D, so speak to your local R&D office

Can I access this training from outside the UK?

No. NIHR GCP courses explore the application of GCP within UK regulations, policies and frameworks, so access is limited to UK-based researchers at eligible organisations. Unfortunately we are not able to recommend alternative providers for researchers based overseas.

Where should I start?

If you know which course you need, go straight to NIHR Learn and search the GCP catalogue. If you are not sure, start with the NIHR GCP page. Either way, check your own organisation’s SOPs before booking, because your employer decides what you need and how often you need it.

Related reading

• Blog – GCP Training: Do We Really Need Regular Refreshers?
• Updated – UK HRA Good Clinical Practice Guideline
• Blog – What I Wish I Knew Before Working in Clinical Trials
• Capacity & Consent to Research Resources
• Podcast – Behind the Approval: Research Ethics and Consent
• Dementia Research Ethics Resources
• NIHR Clinical Trials Toolkit

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Last reviewed: August 2026. Updated to reflect the amended UK Clinical Trials Regulations and ICH GCP E6(R3), which both took full effect on 28 April 2026.