Regulatory Considerations DMEG Update – September 2024

Date: September 24, 2024

The Regulatory Considerations DMEG are waiting for the release of ICH GCP E6 (R3) Annex 1 effective (expected by end of the year) and Annex 2 draft for review by end of September. Once released, we expect to review Annex 2 on behalf of ACDM and send comments to the authors.

In June, I attended as a representative of the ACDM at a GCP Inspectors Working Group, where there were representatives from the Danish regulatory authorities, the eClinical Forum Essential Metadata team, and the industry. The scope of the meeting was to gather feedback on the ongoing work on essential metadata conducted by the eClinical Forum. It was a two-day meeting, with the first day focused on essential metadata and the second day on new potential guidance regarding AI.

The authorities have received many questions asking about what is or is not essential metadata, the stance taken in ICH E6 (R3) is that it is the sponsor’s responsibility to define the essential metadata for their trial, and to ensure that all essential metadata remains available for inspection (in the TMF, in the original system, or in some other fashion) for the full retention period. The inspectors will then comment on the available essential metadata when performing inspections. It was decided that there should be a formal presentation of the list produced by the eClinical Forum to the full EMA GCP IWG when it is released, and that this is preliminarily planned for Q1 of 2025.

With regards to the AI session, the industry stakeholders at the meeting agreed that the draft AI guidance document written by the DKMA was a good guidance, and they would like to see it released as an EMA guidance.

– Silvia Perez Torres, Regulatory Considerations DMEG Chair

Find out more about the Regulatory Considerations DMEG here.

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