The dose-response describes the change in effect caused by differing doses to a Medicinal Product after a certain exposure time. This may apply to individuals, or to populations. Source: EU Clinical Trials Register
A trial where the investigators and the subjects included in the trial (healthy volunteers or patients) dont know which treatment is given. Source: EU Clinical Trials Register
A measure of whether the medicinal product has its intended effect. Source: EU Clinical Trials Register
Subjects are aged 65 years or more. Source: EU Clinical Trials Register
European Medicines Agency’s decision number for the Paediatric Investigation Plan (PIP). Source: EU Clinical Trials Register
Situation where urgent care is needed for the patient and this involves enrolment in the trial (for example: head injury). Source: EU Clinical Trials Register
Independent reviewing body that considers and approves/disapproves biomedical research involving human subjects. Ethics Committee approval is required for each clinical study protocol and Principal Investigator prior to study initiation. Source: EU Clinical Trials Register
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance …
When registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. Source: EU Clinical Trials Register
Marketed Product’s EudraVigilance Number. Source: EU Clinical Trials Register