Research Roadmap

Once approval has been received, it is possible to register the study in a trial register. Although such registration is voluntary, it is important to note that, in order to qualify for publication in an increasing number of medical and biomedical journals, registration in a public register approved by the WHO is mandatory.

For studies involving medicinal products, this requirement is met automatically by applying in CTIS and completing the associated form (required for submission to an assessment committee). This information is then published in the EU Clinical Trials Register.

For all other studies that are subject to the WMO, the researcher must arrange for registration with a register that has been approved by the WHO (free of charge). The WHO website lists a variety of international, Europe and national registers that are available and that meet the registration requirements. The registers that are most commonly used within Amsterdam UMC are clinicaltrails.gov, ISRCTN Registry and Overview of Medical Research in the Netherlands (OMON).

Important: Registration in a trial register must be completed before the first subject signs the consent statement.