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 |