Investigator-Initiated Trials (IITs), often referred to as non-commercial clinical trials, predominantly address questions that have arisen from medical treatment practice. IITs, like pharma-sponsored (commercial) clinical trials, fall under the definitions and regulations of the German Medicines Act (AMG), the German Regulation on Good Clinical Practice (GCP-V) and EU legislation.

In order to deepen her knowledge in this field, one of ClinTriCare’s Senior Project Leaders attended a seminar held by Clinrex GmbH in Munich on 12 June 2013 covering definitions and requirements that characterize an IIT. The seminar also included a discussion of the consequences resulting from the new legislation (16th amendment of the German Medicines Act) for IITs and important points that should be included in an IIT contract.