Monday, August 1, 2016
The International Conference on Harmonisation’s (ICH) Guideline for Good Clinical Practice (GCP; document E6) is currently being revised. The FDA published the new version, which will be called E6 (R2), as a draft document in the Federal Register in June 2015. The draft contains numerous revisions that address changes in the scale, complexity, and cost of clinical trials since the previous version was adopted. Since clinical researchers have access to new technology and risk management processes that may increase efficiency and focus on relevant clinical trial activities, E6 is being amended to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while ensuring that human subject protection and data integrity are maintained. In addition, the update includes changes to clarify standards on electronic records and essential documents. Ultimately, the new document is designed to help clinical researchers protect human subjects, maintain data quality and integrity, and properly document trial results. This article will highlight the key changes that affect research practitioners. These revisions are expected to be reviewed and accepted within ICH and then incorporated into the E6 document by the end of 2016.