End of study

Premature termination

Has your study terminated earlier than foreseen in the protocol? In that case, within 15 days you must notify the review committee (MREC or CCMO) and, in case of a research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation), the competent authority (CCMO or Ministry of Health, Welfare and Sport) as well, stating the reason for termination.

Information on how to report premature termination of research with medical devices can be found at Early termination.

End of study in accordance with the research protocol

Rules apply for notifying the end of trial in accordance with the research protocol.

Research with a medicinal product subject to the Dutch WMO Act (under previous legislation)

In case of research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation) the review committee (MREC or CCMO) must be informed of the end date within 90 days of the end of the study. This concerns the end date in the Netherlands. In a multinational study the start and end date for the research part outside the Netherlands may be different.

Furthermore, in case of termination of a research with a medicinal product subject to the Dutch WMO Act (under previous legislation), you are required to notify the review committee (MREC or CCMO) and the competent authority (CCMO or Ministry of Health, Welfare and Sport) of the the global end date of the trial within 90 days, using  the EudraCT-form End of Trial (B7). If your trial has ended in the Netherlands but is being migrated to CTR for other EU member states, you are to submit to the competent authorities the B7 form stating the end date in the Netherlands. The worldwide end date will then be published in CTIS.

Research with medical devices

Information on how to report the end of research with medical devices can be found at End-of-study in accordance with the investigation protocol.

Other research

The review committee (MREC or CCMO) must be notified of the end date as defined in the protocol within 56 days (8 weeks) of the end of the study. Usually this is the date on which the last measurement was carried out at the last subject. This concerns the end date in The Netherlands. In a multinational study the start and end date for the research part outside the Netherlands may be different.

How to submit

Is CCMO the reviewing committee? Please use the CCMO form 'Notification end of study' to notify the termination (premature or as per protocol) of the study in the Netherlands. In case of research with a medicinal product that is subject to the Dutch WMO Act (under previous legislation) you are also required to use the EudraCT-formulier End of Trial (B7) for notifying CCMO of the date of the global end of trial. You may send these forms to tc@ccmo.nl, stating the NL-number of the study.

If an accredited MREC has reviewed your study, ask them for their policy with regards to (the way of) notification of the end of study.

For notifying the competent authority of the date of the global end of study  you are required to send the EudraCT-form End of Trial (B7) to bi@ccmo.nl (if CCMO is the competent authority) or to info-bi@cbg-meb.nl (if the Ministry of Health, Welfare and Sport is the competent authority).