Research Roadmap

Within one year after the completion of the study (worldwide), the sponsor/principal investigator must notify the relevant authorities of the study results.

Clinical trials involving medicinal products

A summary of the final results must be submitted via CTIS, including a version written in layperson-friendly language. For more information, refer to the CCMO website and the ECTR regulation.

For CTD trials that did not transition to the CTR, the final results must be reported in EudraCT.
In case of a clinical trial involving children, the deadline is six months after study completion.

Clinical investigations involving medical devices (MDR article 62/74.1/74.2) and IVD performance studies

A summary of the final results must be submitted to the review committee (MREC or CCMO) via the Research Portal, including a version written in layperson-friendly language. If the investigation is terminated prematurely, the deadline for submission is three months instead of one year. For more information, refer to the CCMO website (MDR or IVDR).

Other research subject to the WMO (including MDR article 82)

A summary of the final results and/or a scientific publication must be submitted to the review committee (MREC or CCMO) via the Research Portal. You may also include a lay summary in your submission. More information is available on the CCMO website.

Important notes:

• Also ensure that the status of your study is updated in the trial register where it is registered and that the results are entered.
• For details on local procedures in Amsterdam UMC, consult the MREC Amsterdam UMC website.
• Consult the CCMO website for guidance on using the Research Portal.