Project registration at ClinicalTrials.gov

Clinical trials must be registered at ClinicalTrials.gov. A number of journals require that these studies are published in ClinicalTrials.gov. Failure to register the study may therefore mean that you are not allowed to publish.

Clinical trials include both pharmaceutical drug testing and other patient-close research where the purpose is to test or compare the effect of various treatments, including observational studies.

All studies "which prospectively include individuals to one treatment group or to comparative groups to investigate the effects of health related endpoints" are subject to mandatory registration. In practice, this means that journals that follow ICMJE's standards (icmje.org) require registration of most clinical trials; not only for randomised studies or pharmaceutical drug studies, but also for:

• Studies involving only one group of patients, e.g. an uncontrolled testing of a treatment method at a local hospital in Norway.
• Studies where "only" the side effects or complications of a treatment or a diagnostic method are investigated.
• Studies looking at effects or side effects of diets, behavioral therapy, medical equipment, access to healthcare, etc

If you are employed at OsloMet and the study has not been conducted at a healthcare company, the study must be registered at OsloMet. An exception is if the project manager is employed elsewhere and wishes to register the study under his /her institution.

If the study is conducted at a healthcare company, contact the research support department at the company in question and ask if they have established an institutional account at ClinicalTrials.gov and whether they know if the study should be registered with them. If they cannot provide a clear answer, we recommend that the study be registered at OsloMet.

If you are not employed at OsloMet and the study has not been conducted at a healthcare company with an institutional account at ClinicalTrials.gov, you can contact the R&D administration for further clarification on where to register.

The project manager is responsible for registering the project before start-up.

After approval from REK you must send an e-mail to fou-hf@oslomet.no and request about creating an account in ClinicalTrials.gov. The R&D section at HF creates an account and you will receive login information (link, username and password) from ClinicalTrials.gov.

We recommend that you read the instructions at ClinicalTrials.gov carefully. The R&D administration will also be able give you tips and advice. Fellows who register their project must meet with supervisor.

You create a study by pressing "create" under "protocol records".

Formal guidelines on how to fill in some parts of the form (PDF). Print this!

After completing the registration, the study has status as In Progress. Now press "completed". If you are listed as PI and as the “responsible party”, you should review and check that everything is OK before you press next action "Approved" and then next action "Release".

If you are not listed as the "responsible party", proceed to "Completed". The PRS administrator (the R&D administration) will be notified that the study is ready for release. When the study has status as "Released", it will be visible on ClinicalTrials.gov after 3-5 business days.

The study should be updated on a regular basis - at least every six months - when you change the status of the project (recruiting not started, recruiting, recruiting completed, results). ClinicalTrials.gov will also send an e-mail with a reminder that the project needs to be updated.

You will find more information about the database at Clinical trials gov.