When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical separate Clinical Trial Application to each Competent Authority.
Latest Glossary Definitions
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events that occur during their clinical trials.
A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.
Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources, there are new risks causally associated wit