EMA Updated Q&A: Good Clinical Practice

On 16 February 2021 the EMA updated GCP Q&A by adding a new Q&A (#15) to the GCP Matters section.

The scope of the question above addresses only GCP inspections requested by the CHMP.

The purpose of this document is to state the importance of sponsors to include an explicit passage in their informed consent form (ICF) regarding the authorization for EU inspectors to direct access and review of trial participants’ medical records (including applicable electronic systems) and other personal data in EU/EEA and non-EU/EEA countries.

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