The latest revision of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH GCP E6(R3)) brings significant changes compared to the previous revision (R2). Among the most impactful additions is its new data governance section, which expands on the topic’s pre-existing sparse coverage. The guideline now clearly states the requirements for collecting, managing, and protecting data throughout their life cycle. This article addresses topics within each subsection of this new data governance section in light of current processes: establishing a contingency plan, defining electronic case report form (eCRF) specifications, training users and defining their access rights, using an audit trail, safegarding blinded information, transferring data between computerised systems, cleaning and validating data, archiving and destroying data, and other topics. It also presents advantages and challenges of the newly added section and makes some recommendations about how to incorporate it into in real-life practices.
Fady Fares (Mon,) studied this question.