Research Roadmap

Various laws and regulations (CTR, MDR, IVDR) as well as international standards (ICH-GCP, Declaration of Helsinki) require transparency and public disclosure of study records, including core data and results. In addition, the International Committee of Medical Journal Editors (ICMJE) has set prospective (before first patient in*) registration in a publicly accessible registry approved by the World Health Organization (WHO) as a requirement for publication in scientific journals.

For clinial trials involving medicinal products, the requirement is automatically fulfilled by submitting the study in CTIS and completing the associated form. Relevant study information is then made publicly available in the EU Clinical Trials Register. Information from the public section of CTIS is also automatically published in the Overview of Medical Research in the Netherlands (OMON).

Research subject to the WMO, MDR or IVDR, as well as non-WMO research submitted via the Research Portal, is automatically published in OMON (within 7 working days after the decision of the review committee) and the WHO International Clinical Trial Registry Platform (ICTRP). 

Study records are updated by submitting amendments or reports through the Research Portal and/or CTIS.

Registration in additional public registries is optional. The WHO website provides a list of international, European and national registries that meet the WHO registration standards. At Amsterdam UMC, the most commonly used registries are ClinicalTrials.gov and the ISRCTN Registry. 

*Important: registration in a trial registry must be completed after approval for the study is obtained from a review committee and before the first participant signs the informed consent form.