[Public GCP unit--experiences from the Aarhus University Hospital]

According to the EU GCP-directive, all clinical trials involving medical products must adhere to the GCP-standards by May 2004. This may entail difficulties for investigator-initiated trials not sponsored by the industry. A public GCP-unit was established at Aarhus University Hospital in 1995. The unit offers researchers a monitoring system including discussion of the protocol, check of formalities, and verification of data and protocol compliance. As a contribution to the future work with GCP, experience from the GCP-unit at Aarhus University Hospital is presented here.