Suspension

In the event of the trial proving to be significantly more unfavourable to the subject than the research protocol had suggested, the investigator is required to suspend the study until such time as continuation is approved by the committee in question (MREC or CCMO). The reviewing committee must be notified of the decision to suspend the study immediately, giving reasons;

Premature termination

The study is terminated earlier than foreseen in the research protocol

Is your study terminated earlier than foreseen in the protocol? You then have to notify this within 15 days to the reviewing committee (MREC or CCMO) and, in case of a research with a medicinal product, also to the competent authority (CCMO or Ministry of Health, Welfare and Sport), stating the reason for termination.

End of trial

The study is terminated in accordance with the research protocol.

For notifying the end of trial different rules apply for research with or without a medicinal product.

Research without a medicinal product

The reviewing 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.

Research with a medicinal product

In case of research with a medicinal product the reviewing committee (MREC or CCMO) must be notified 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, you are required to notify the date of the global end of trial within 90 days to the reviewing committee (MREC or CCMO) and to the competent authority (CCMO or Ministry of Health, Welfare and Sport), using  the EudraCT-form End of Trial (B7).

Way of submitting

Is the CCMO the reviewing committee? Then use the CCMO form 'Notification end of study' to notify the (premature) termination of the research in the Netherlands. In case of research with a medicinal product you are also required to use the EudraCT-formulier End of Trial (B7) for notifying the date of the global end of trial. You may submit these forms by post or digitally to tc@ccmo.nl, mentioning the NL-number of the study.

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

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