The International Council for Harmonisation (ICH) announced on Tuesday the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical studies.
The guideline received endorsement from the ICH Assembly, reaching Step 4 of the ICH process and indicating it is ready for adoption by regulatory authorities. The document was initially released as Step 2 and made available for public consultation on 19 May 2023. (RELATED: E6(R3): ICH releases draft of revamped GCP guideline for consultation, Regulatory Focus 25 May 2023)
Overall, the guideline covers some key principles of for conducting clinical trials, as well as the responsibilities and composition for institutional review boards and independent ethics committees (IRB/IEC)…
