Clinical trial professionals are likely aware of significant changes in Good Clinical Practice (GCP) standards since the initial release of ICH E6 GCP guidance. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently finalized their addendum to the original E6 guidance for Good Clinical Practice (GCP). This was spurred by the move away from paper-based source documents toward electronic data capture (EDC) technology. The purpose of this update was to expound upon ways to modernize clinical trial conduct—based on recognition of the growing cost and complexity of clinical trials and the increased capability of modern technology.
This modern approach is referred to as risk-based quality management (RBQM). As studies become more complex and expensive, utilizing emerging technology should benefit sponsors and contract research organizations (CROs).
Advances in technology, such as electronic capture and storage of study data and documentation, have accommodated the growing reliance on RBQM for clinical trials. With any new technology, there are questions about implementation and best practices.