Ethics & legal

A vital prerequisite for the start of most diagnostic studies is the involvement of an ethics committee and legal authorities. Without a positive opinion of the committee and the permission from the authorities no study can be legally conducted. Furthermore, both must be continuously informed about certain events during a study. ICS will assess the requirements for ethics committee approval for your project. If required, for example in case of interventional or higher risk class studies, we will do the necessary communication for you, i.e. write and submit the applications, report significant information (adverse events, study termination, study closure), and submit relevant documents (CPSP, investigator brochure, informed consent, progress reports, amendments, CPSR).