Reporting of results in EudraCT

Introduction

EudraCT is a clinical trial registry where European clinical trials were previously registered. From the 31 January 2023, EudraCT has been replaced by a new web portal, CTIS. Therefore, all new clinical trials must be registered in CTIS instead of EudraCT.

Ongoing trials already registered in EudraCT and where the trial is expected to be completed after 31 January 2025 need to be transferred to the new system, CTIS. For more information on transitional trials, please visit our webpage on CTIS.

However, trials already registered in EudraCT and where the trial is expected to be completed before 31 January 2025 will not be affected by this change and the results must be reported in the old system, EudraCT.

Reporting of results

According to the Clinical Trials Directive 2001/20/EG, the results from a clinical trial must be reported within 12 months from study completion (6 months for pediatric trials). To report results in EudraCT, please follow steps 1 and 2:

1. Once the trial has been completed, you as a Principal Investigator (PI) need to notify the Medical Product Agency (Läkemedelsverket) about the completion within 90 days after study completion. This is important in order for the study status to change from ”ongoing” to ”completed” in the system. You can read more on study completion at Läkemedelsverket’s webpage.
2. In order to report results in EudraCT you need to have an account. To simplify the process for reporting of results for all researchers, we at Compliance & Data Office (CDO) offer help with this so that each PI doesn’t need to create their own account in EudraCT. We have a Primary Account from where we can report your results. All we ask from the PI is that you fill in the document ”Template for reporting of results in EudraCT” (found at the bottom of this page) and send it to compliance@ki.se together with the published article or manuscript. Would you rather report the results by yourself in EudraCT, you can find the information on how to do this at the EudraCT webpage. Please let us know if you choose to report your results on your own.

For clinical trials completed before the 21 July 2013, it is sufficient to upload a summary of results. Then you only need to follow step 1 and thereafter contact us at CDO and we will help you upload the summary.

Even if the results have already been published in a scientific journal, results must still be reported in EudraCT.