ACDM News Item

ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review

Date: June 19, 2023

The R&D industry, especially those that are working on clinical trials, have been waiting for the new release of ICH GCP E6. The 3rd revision of the Good Clinical Practice (GCP) E6 guidance has been recently published as a draft, for public review and consultation.

What is changing in E6 revision 3? E6 is undergoing a complete restructure with the aim to address the complexity, diversity and new technology deployed in modern clinical trials and will consist mainly in two different main sections. One mainly focused on ‘traditional’ interventional clinical trials (Annex 1) and the other on ‘non-traditional’ clinical trials, to include designs such as pragmatic and decentralized clinical trials (Annex 2).

The ACDM Regulatory Considerations Expert Group is going to initiate a thorough review of this new draft guidance, to assess how new recommendations will impact on clinical trials and on any activities where data management is directly or indirectly involved.

If you are interested in knowing more about this new ICH GCP guidance, and would like to be involved in this new challenge across the clinical trials environment, please reach out to the ACDM group or DMEG chair, Silvia Perez-Torres: https://lnkd.in/dCRGK5T%20

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