Committee for Proprietary Medicinal Products [CPMP]

The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give their informed consent before they can enrol in a trial.

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or negative opinion. This is to ascertain that the research is conducted in compliance with European regulations, directives and guidelines defined by the International Conference on Harmonisation. This is an international quality standard that describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.