Since its release 11 years ago, ICH Guideline E14 has governed the clinical proarrhythmic cardiac safety regulatory landscape: it has been adopted by the United States Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The guideline addresses the Thorough QT/QTc (TQT) study, a dedicated trial designed to prospectively exclude an unacceptable degree of drug-induced QTc interval prolongation or to identify the need for more intensive and extensive electrocardiogram (ECG) monitoring in Phase III trials than would usually be the case for a drug in the same class. 

In this fact sheet, we answer some frequently asked questions regarding these changes.