ICH releases draft GCP guidance

The International Council for Harmonisation (ICH) has published a draft version of its updated principles for good clinical practice (GCP).

The principles have been designed in a way to provide a flexible framework for clinical trial conduct and to provide guidance throughout the lifecycle of the clinical trial. The guidance is intended to cover all aspects of running a trial from study design, incorporation of innovative digital health technologies, safety and protection of participants and increasing stakeholder engagement during study design.

There are 12 key principles set out in the guidance, most of which have subdivisions providing even more detail on the practical application and implications of a principle. Principles include the stipulation that trials should be conducted in accordance with GCP and the Declaration of Helsinki, be safe for participants, be based on robust scientific knowledge and be conducted by qualified professionals using investigational products manufactured according to GMP standards.

The document is yet to reach Step 2 of the ICH guideline development process. At this stage, the document will include Annex 1 on addressing interventional clinical trials and Annex 2 on additional considerations for non-traditional interventional clinical trials. Once this has been reviewed, the document will be open for public comments. The draft guidance has been published at this stage prior to the consultation, as the ICH aims to increase transparency and facilitate a greater common understanding of the key principles of good clinical practice.

To read the GCP principles, click here.