End of trial notification and publication of results
How do I report the trial results to the Danish Medicines Agency?As soon as possible and no later than one year after the trial has ended, the trial results must be entered in EudraCT. Subsequently, data will be published on clinicaltrialsregister.eu.This means that you no longer have to submit the trial results to us. You can read more about registering a trial and updating its information (all steps to be followed for the submission of a trial in EudraCT, until its results posting) and read more about how to enter the results in EudraCT. Since the data become publicly available, you are not required to send a publication to us in future. Please note that phase I trials are not published on clinicaltrialsregister.eu (except for studies in children), so you still have to send the publication for phases I trials to us. Read more in the EMA Frequently Asked Questions regarding results in EudraCT and EU CTR and under ’Result related documentation’ and see the EU Commissions Letter to Stakeholders regarding the requirements to provide results for authorised clinical trials in EudraCT.
If the trial has been approved, but no participants have been included, a PDF-document should be uploaded explaining why the trial is terminated. Please see section 70 in the abovementioned EMA Frequently Asked Questions.
The Danish Medicines Agency will, if deemed necessary, request the complete report.
The Danish Medicines Agency will contact you if the requirements are not met. After this, there will be a dialogue with the Sponsor regarding the publication of the results prior to any charges filled with the police.
Studies in childrenAs regards studies in children based on a paediatric investigation plan, the trial results must be entered in EudraCT within six months.
A paediatric investigation plan must be prepared at the time of filing a marketing authorisation for a new medicinal product, a new indication (including paediatric indications), a new pharmaceutical form or a new route of administration for an already approved product.
This is provided by regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, which entered into force on 26 January 2007.
16 December 2022 - Added link to EMA Frequently Asked Questions and described procedure for reporting results when no participants have been included.