Clinical Trials Involving Drugs and Medical Devices
The term “Clinical trials” refers in this context to researcher initiated clinical trials in which the intervention is drugs, with or without marketing authorization, or clinical testing of medical devices.
For clinical trials conducted at Oslo University Hospital (OUS) involving medications, or with the intention of CE-marking a medical device, the national quality documents for drug testing and medical devices developed by NorCRIN apply. The documents cover regulatory requirements for the planning, conduct and completion phases of a clinical trial.
Much of the information on these pages will refer directly to NorCRIN's procedures (most documents are in Norwegian). The procedures describe submission and reporting obligations towards the Regional Committees for Medical and Health Research Ethics (REK) and the Norwegian Medicines Agency (NoMA/SLV). Testing of medical devices follows approximately the same procedure as drug testing and will not be described separately here, but keep in mind that there are separate quality documents for medical device trials.
Use of the quality documents is described in this flow chart which shows which procedures must be followed at different stages of the trial.
Standard Operating Procedures (SOPs) must be followed. Checklists, templates and other attachments can be adapted to the individual trial as long as the purpose of the documents is maintained.
For OUS, the eHåndboken (OUS’ electronic manual) document describing roles and responsibilities in clinical trials and testing of medical devices (in Norwegian) applies.