International – ICH shares « work-in-progress » update to GCP guidance

The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.

“The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials,” noted ICH.

In an explanatory note prefacing the draft updates, ICH explained that the updates to the good clinical practice (GCP) guidelines are designed to align with the revised guideline on general considerations for clinical studies, ICH E8(R1). The latter guideline “includes a framework for designing quality into clinical trials, stakeholder engagement, trial design, proportionate trial management and focus on factors critical to the quality of trials,” said ICH in the forward to the draft guidance…