Good Clinical Practice - GCP

GCP is a quality standard for clinical research that is legally required for clinical trials involving drugs and/or medical devices. This requirement applies regardless of whether the drug has marketing authorisation or not. It is a good standard that can also be beneficially applied to other types of clinical research. Procedures and templates based on GCP can be found on NorCRIN's website.

The Clinical Trials Unit offers GCP courses four times a year at Oslo University Hospital (OUS) and at other healthcare institutions upon request. All GCP courses in South-Eastern Norway and elsewhere in the country are advertised on NorCRIN's website and are open to everyone.

The legislation does not set any requirements for how often one must take a GCP course or renew their knowledge of GCP. We recommend renewing GCP certification regularly to stay up to date, preferably every 2–3 years. Recertification will also be necessary when there is an update to the ICH GCP guidelines.

We offer to review drug trial protocols before they are submitted to the authorities to ensure that the design and statistics are appropriate and that the legal requirements are in place. We recommend using the Transcelerate protocol template. If another template is used, it must cover the points described in NorCRIN's checklist. The CTU requires at least 14 days for such a review.

GCP-related questions can be directed to ctu@ous.hf.no.