Table 1.

Summary of commonly referenced International Conference on Harmonization (ICH) clinical efficacy guidelines

Document	Subject	Content
ICH E 2	Adverse Event Reporting	Defines terms, timeframes for AE reporting and formatting of AE reports
ICH E 6	GCP Consolidated Guidelines	Defines responsibilities of sponsors, investigators, consent process monitoring and auditing procedures, and protection of human subjects
ICH E 9	Statistical Principles	Design and conduct of trials intended to support or establish efficacy
ICH E 10	Choice of Control Groups	Properties and limitations of different kinds of control groups (active control equivalence, non-inferiority, etc.)
ICH E 11	Clinical Investigations in Pediatric Population	Principles of clinical investigations in children, including timing of studies and extrapolation of data relative to studies conducted in adults, consent, assent, and interventions
ICH E 14	Evaluation of QT/QTc Interval Prolongation	Testing the effects of new agents on the QT/QTc interval as well as cardiovascular adverse events