About the GCP units

The GCP units are located in Copenhagen, Aalborg, Aarhus and Odense. The units are set up with the purpose of helping non-commercial researchers comply with Good Clinical Practice (GCP) and Danish legislation. The GCP units are not an authority but a public partner who, as far as possible, will help researchers organize and carry out a clinical trial, so that Danish law and GCP will be complied with. It is, however, still the researcher, who in GCP terminology is the sponsor (the one who manages and commences the trial), who is responsible for the work being performed. 

The GCP units offer guidance and a systematic review of the clinical trial before, during and after the trial is carried out. We have a vast experience in how clinical trials are planned and performed to ensure that GCP becomes a shortcut to good research. 

The GCP units prefer to be involved early in the process, if possible, already when the protocol is under development in order to obtain the best results, facilitate the processing at the three authorities where the clinical trial is to be submitted (the Danish Medicines Agency, the system of research Ethics Committees, and the Danish Data Protection Agency) and in order to make the trial easier to deal with along the way.

Following a request to one of the GCP units, a GCP coordinator/monitor will be assigned to the trial and be responsible for guidance and monitoring and in cooperation with the researcher, develop a cooperation agreement and a monitoring plan. If more than one site participate in the trial, the GCP unit first contacted will involve other relevant GCP units in Denmark, so that all sites in the study will be covered by our services.