Clinical Research Professional,
*Corresponding author. E-mail address: drakashaher@gmail.com (A Aher)
An updated version of the Good Clinical Practice Guideline, E6(R3), has been made available by the International Council for Harmonization. This guideline places a strong emphasis on a more adaptable, risk-based method of trial supervision. Quality by Design (QbD) adoption, attention to Critical-to-Quality (CtQ) factors, participant safety enhancement, adoption of Digital Health Technologies (DHTs), decentralized trials, elucidation of sponsor, investigator roles and responsibilities are some of the major effects. The implementation of risk-based monitoring, updating SOPs, quality systems, bolstering data governance with technologies like audit trails and metadata are examples of operational impacts. These updates seek to minimize needless burden, safeguard the rights, safety, and well-being of trial participants, promote innovation in trial design and conduct, and assure data reliability.
This review article provides a comprehensive review of the major revisions to the GCP guidelines, offering insights into the E6(R3) framework, its key impacts, and the essential takeaways for modern clinical trial conduct.
Good Clinical Practice, ICH E6(R3), Clinical Trial Innovation, Digital Health Technologies, Risk-Based Monitoring, Fit-for-Purpose
