GCP is a quality standard for clinical research that is required by law for trials involving drugs. The requirement applies regardless of whether the drug has a marketing authorization or not. It is a good standard that also can be used to advantage in other types of clinical research. Procedures and templates based on GCP can be found on the NorCRIN web pages.

CTU holds GCP courses 4 times a year at OUS (see Courses), twice a year at Ahus, and at other hospitals on request. All GCP courses in South Eastern Norway Health Region and elsewhere in the country are announced at the NorCRIN web pages and are open to everyone.

We offer to read through protocols before submission in order to check that design and statistics are suitable and that regulatory requirements are met. We recommend using the Transcelerate protocol template. If another template is used, it should cover the points described in NorCRIN's checklist. The protocol must be sent to the  CTU mailbox no later than 14 days prior to submission.

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