Registration at Helsenorge.no and on the hospitals' websites

Clinical treatment and rehabilitation studies that may affect the treatment course of the research participants and which are open for inclusion, or where Ethics Committee (REK) approval is obtained and the start date is set, should be published on the hospital's website.

Studies published here will be mirrored on Helsenorge’s website helsenorge.no/kliniske-studier.

This website is established on behalf of the Ministry of Health and Care Services (HOD) and will serve as a national overview. Patients, relatives and referring physicians can use the webpage to find information about studies that are being carried out at all Norwegian hospitals.

All studies published on helsenorge.no/kliniske-studier will also be displayed as part of the relevant treatment programme, i.e. the texts published under "Behandlinger og undersøkelser fra A til Å" (treatments and examinations) on the hospitals' Internet pages. The purpose is that trial information should be easily accessible to patients / relatives who seek information about current treatments on the website. Since all the hospitals’ Internet pages use a common platform, the clinical trials of all hospitals will also be displayed under all other hospitals' treatment programmes.

If there is no suitable treatment programme, one should consider whether to create a new text, as it can often be difficult for patients to locate relevant trials on the web pages where all studies are published. Contact your local patient information coordinator or website administrator if there is a need to post new treatment programmes in connection with the publication of a clinical trial.

Studies at OUS are also published collectively on the site oslo-universitetssykehus.no/kliniske-studier. This page also shows studies at other hospitals, these are marked with an arrow indicating an external link.

Completion of the registration form (template can be found as an attachment to this document) should be done by the project manager/PI who is responsible for the REK application, or his/her authorized representative.

Multicenter trials should be registered only once, with all participating institutions listed. It is important that the completed form complies with the REK approval and the approved protocol. The national coordinating investigator (NC) is responsible for registering multicenter trials.

Routine for registration - OUS

Once REK approval is granted and the trial start date is set, the project manager/PI must complete the registration form, including start date for inclusion, and send it by email to the communication staff at OUS: post.kommunikasjon@ous-hf.no. The communication staff will arrange for the study to be published within two weeks of receipt, or when inclusion starts. The project manager must check that the study is published correctly.

Notification of end of recruitment

The project manager should send an email to post.kommunikasjon@ous-hf.no when a trial ends recruitment.

The communication staff will then ensure that the study is transferred from the list of ongoing, recruiting studies on the Helsenorge website to ongoing studies that have completed recruitment. In addition, the study will be removed from the treatment program pages on the hospital's website, but will still remain on oslo-universitetssykehus.no/clinical-studies with information that the study is closed for inclusion.

Project Completion Notification

Upon completion of data collection in the trial, an email informing about this should be sent to post.kommunikasjon@ous-hf.no. The trial will then be removed from the web pages at helsenorge.no/kliniske-studier and oslo-universitetssykehus.no/kliniske-studier.