ICH Guidelines on eTMF Audit Requirements
ICH Guidelines on eTMF Audit Requirements How ICH Guidelines Shape Audit Requirements for eTMF Systems ICH GCP Overview: A Foundation for Audit Trail Expectations The International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines provide the gold standard framework for managing clinical trial documentation, including expectations around audit trails. Specifically, ICH E6(R2) emphasizes that…