Independent Ethics Committee opinion. Source: EU Clinical Trials Register
Any medicinal product consisting of vaccines, toxins, serums or allergen products used to produce an immunological response. Source: EU Clinical Trials Register
Investigational Medicinal Product has a Marketing Authorisation in the Member State concerned by this application. Source: EU Clinical Trials Register
An interventional trial sets up to discover or verify the effects of one or more investigational medicinal product(s) (IMP), to ascertain its (their) safety and/or efficacy. The assignment of the patient to a particular therapeutic strategy is decided in advance …
A doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires. The investigator is responsible for the conduct of a clinical trial at …
Within the living body (animal/man). A phenomenon that occurs in real life, as opposed to in the laboratory (“in vitro”). Source: EU Clinical Trials Register
Subjects are aged 28 days to less than 2 years. Source: EU Clinical Trials Register
The International Non-proprietary name for an active substance. Source: EU Clinical Trials Register
International Standard Randomised Controlled Trial Number is used for the identification of clinical trials worldwide. The randomly generated, eight-digit ISRCTN is unique to a registered trial at current controlled trials, thereby ensuring that the trial can be simply and unambiguously …
Interactive Voice Response System: commonly used for randomisation of treatment and controlling the shipment of stock of product. Source: EU Clinical Trials Register