Good Clinical Practice

Good Clinical Practice (GCP) establishes an international standard for clinical trials involving human participants. It includes the:

  • design
  • conduct
  • recording
  • reporting of these clinical trials

It outlines what sponsors, investigators, and other stakeholders must do to protect the trial participants' rights, safety, and well-being. It also ensures the integrity and credibility of clinical trial data.

Updated guidelines

ICH E6 (R3) – Revised Guideline

This updated version has taken effect in Europe on 23 July 2025.

You can read it here: ICH E6 (R3): Guideline on Good Clinical Practice – Step 5

Key updates in ICH E6 (R3)

To make it clearer and easier to read, the new guideline has a new structure. It includes:

  • Overarching principles and objectives
  • Annex 1 - applicable for interventional clinical trials
  • Annex 2 (coming later in 2025) - additional considerations for non-traditional interventional clinical trials

The Overarching Principles and Annex 1 have already been adopted by ICH and CHMP and are effective in Europe from 23 July 2025. Annex 2 is expected to be finalised later in 2025. 

The key updates include:

  • Introduces innovative provisions applicable across various types and settings of clinical trials. This ensures continued relevance as technology and methods advance.
  • Encourages a risk-based and proportionate approach to conducting clinical trials. This promotes fit-for-purpose solutions.
  • Fosters greater transparency through clinical trial registration and result reporting
  • Additional guidance to enhance the informed consent process

Training requirements

Appropriate and adequate training on ICH GCP E6 R3 is essential. This will help to:

  • Maintain compliance with regulatory requirements
  • Enhance the quality and reliability of clinical trial data
  • Ensure the protection of trial participants

Investigator and persons or parties to whom the investigator has delegated trial-related activities

The Principal Investigator (PI) is the person in charge of running the clinical trial at a site. They are responsible for:

  • Protecting the rights, safety, and well-being of the people taking part in the trial

  • Making sure the data collected is accurate and reliable

Because of this, PIs are expected to be trained and familiar with the latest version of the international guidelines for clinical trials, known as ICH E6 R3.

Sometimes, the PI may delegate certain trial-related tasks to other people or groups. These individuals must also be trained appropriately. The amount and type of training they need depends on what is necessary to enable these persons to fulfil their delegated activities that go beyond their usual training and experience.

If someone has already been trained on the previous version of the guidelines (ICH E6 R2), it’s important to consider:

  • What tasks they are doing
  • Whether the updates in ICH E6 R3 affect their role

If there are changes in ICH E6 R3 that affect their work, these persons should be prioritised for retraining. A gap analysis can help to capture your review and prioritisation for who needs retraining. Documentation of this may be requested on inspection. 

Sponsor 

The sponsor must also make sure that everyone involved in the trial, including service providers, are appropriately qualified and trained in ICH E6 R3. The level of training required would depend on what is necessary to enable these persons to fulfil their assigned activities.

Further information

ACT EU coordinated a two-day training workshop in February 2025 on the ICH E6 revision. 

ICH have also indicated that step 5 training materials for the ICH E6 (R3) revision will be published on the ICH website mid-2025.  

You can find further information on our GCP inspections page and on our GCP inspections topics of interest page.