Remember to monitor deadlines in CTIS during the summer period

As the summer season approaches, we would like to draw your attention to the need for forward planning in connection with the holiday period. All case processing will continue as usual in CTIS.

However, please note that Denmark’s initiative for expedited processing of Phase I and integrated Phase I/II trials will not be available during weeks 29–31, 2026. Please read more here.

Sponsors/investigators are advised to pay particular attention to the timelines in CTIS.

Failure to comply with deadlines will result in the application automatically lapsing, making it necessary to submit a new application (resubmission). Deadlines are only available in CTIS. It is therefore recommended to access CTIS regularly throughout the entire application process and to ensure that correct contact details are always maintained in CTIS.

Further information on CTIS timelines and deadlines for clinical trials can be found in the Sponsor’s Handbook (section 3.1.8).

Please note that some deadlines are dynamic, as they may depend, for example, on when the authorities complete their assessment. Additionally, deadlines may occur earlier in mono-national trials.

If resubmission becomes necessary, please refer to the Sponsor’s Handbook (section 2.7.2) for further information.