ICH GCP Update: Sponsor Control Of Clinical Trial Data

Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data.

The recent update of ICH GCP provides new, more detailed guidelines for sponsors regarding the handling of clinical trial data, documents, and systems. Continue reading to learn more about key areas related to control of investigator data and essential documents sponsors should consider as well as their responsibilities for electronic systems and data handling.