As covered in an article by Zachary Brennan in raps.org, the ICH has updated their GCP guideline with the goal to simplify and cut the cost of clinical trials. The aim is to create a more “unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland.” Electronic records and the use of essential documents will provide higher quality and more efficient clinical trials.
Quality management is one of the main criteria for the new guidelines. It focuses on the importance of “human subject protection and the reliability of study results,” and the elimination of risk at both the system and trial levels.
The updated guidelines use a risk-based approach to monitoring clinical trials. While they still require on-site monitoring, centralized monitoring is now being used to provide more extensive methods.
For more information, read Zachary Brennan’s complete article on RAPS.org.