Results other clinical investigations
For other clinical investigations (MDR article 82) or investigations for which a review committee has given a positive decision prior to 26 May 2021, you are required to submit a summary of the results of the investigation to the review committee (accredited MREC or CCMO) within one year of the (premature) end-of-study of the investigation (worldwide) via the Research Portal.
You are required to complete the Study Result form and to submit the summary of the study report (document 'M2b. (Summary of) study report') and preferably a lay summary (document subtype 'M2a. For publication (lay) summary of results') in the document section.
In addition you can submit a scientific publication (document subtype 'M2c. Publications') in the document section.
The results of the study will be published in the Overview of Medical Research in the Netherlands (OMON) and the International Clinical Trials Registry Platform (ICTRP), unless the sponsor has objected against disclosure.
A sample form is available that showcases the questionnaire.
Please note: this form is only a sample template of the questionnaire you are required to fill in online. It cannot be filled in or submitted in this format.
CCMO has indicated its view of publication policy in the memorandum CCMO Statement on publication policy.