The New ICH-GCP Revision 2016

Since 1996, ICH-GCP has set the international standards for the design, conduct and reporting of clinical trials.

In July 2015, the International Conference for Harmonization (ICH) released a draft open for discussion with a deadline on the 31 January 2016 (mainly for EU and US). The new draft includes 26 new points of change pertaining definitions, source documentation process, Investigator’s responsibilities, Sponsor’s responsibilities, as well as changes in handling and processing of Essential Documents of Clinical Trials.

The present article aims to uncover these new points and will attempt to conceptualize how the implementation of this new ICH-GCP update will affect the conduct of Clinical Trials in national, European and Global level.

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