Description
To conduct a clinical trial in the European Economic Area the sponsor must apply for authorization from the national competent authority (i.e. medicines regulator), and favorable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.
In addition to being fully compliant with current European Union legislation, the module looks forward to the implementation of the Clinical Trials Regulation.
