Good Clinical Practice

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

  • design;
  • conduct;
  • recording; and
  • 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.

The ICH GCP guideline ICH E6 (R2) is effective in Europe until 22 July 2025. You can find this linked below.

ICH: E 6 (R2): Guideline for good clinical practice - Step 5

The ICH GCP guideline ICH E6 (R3) (Principles and Annex 1) will be effective in Europe from 23 July 2025. You can find this linked below.

ICH E6 (R3) Guideline on good clinical practice (GCP)_Step 5

To make it clearer and easier to read, ICH E6 (R3) has a new structure. It will include:

  • An overarching principles and objectives document.
  • Annex 1 (interventional clinical trials).
  • Annex 2 (additional considerations for non-traditional interventional clinical trials).

The ICH and CHMP have adopted the overarching principles and Annex 1. They will come into effect on 23 July 2025. Annex 2 is expected to be finalised later in 2025.

This revision of the GCP guideline sets out international standards for clinical trials involving human participants. It was revised following extensive consultation of stakeholders.

  • It introduces innovative provisions to apply across various types and settings of clinical trials. This ensures continued relevance as technology and methods advance.
  • It encourages a risk-based and proportionate approach to conducting clinical trials. This promotes fit-for-purpose solutions.
  • It fosters transparency through clinical trial registration and result reporting.
  • It offers 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

It would be expected that Principal Investigators (PI) are familiar and trained on E6 R3. This is because the PI is responsible for ensuring the rights, safety and well-being of the trial participants and the reliability of data. For other persons or parties to whom the investigator has delegated trial-related activities, trial-related training (including for example level of ICH E6 R3 training required) would depend on what is necessary to enable these persons to fulfil their delegated trial activities that go beyond their usual training and experience.

In terms of retraining (persons already trained on E6 R2), consideration should be given to the tasks being carried out and whether the changes to E6 R3 will have an impact on each role. Where it is identified that there are significant changes in E6 R3 that will impact on a role, these personnel should be prioritised for retraining. It may be beneficial to conduct a gap analysis as a mechanism to capture your review and prioritisation for retraining. Documentation of this may be requested on inspection.

Sponsor

It would also be expected that the sponsor uses appropriately qualified individuals (including service providers) for activities to which they are assigned throughout the trial process. This would include training on 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 in February 2025 on the ICH E6 revision. You can find a recording of this training event at the link below.

ACT EU workshop on ICH E6 R3 (principles and Annex 1) | European Medicines Agency (EMA)

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

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