Published: 18-01-2024 11:38 | Updated: 18-01-2024 11:38

Clinical trials of medicines for humans

Photo: Getty Images
Photo: Getty Images

Since 31 January 2022, the EU-wide Regulation 536/2014, also known as the Clinical Trials Regulation (CTR), applies to clinical trials of medicines for humans. The CTR applies regardless of whether the trials are commercial or not, and thus also covers academic research.

All new clinical trials must be registered in the EU wide web portal CTIS (Clinical Trials Information System). CTIS replaces the old web portal EudraCT.

All ongoing clinical trials, for which Karolinska Institutet is the sponsor, where the study is expected to end after 30 January 2025, need to be moved from EudraCT to CTIS and comply with the new CTR. 

Transition rules for ongoing trials

The PI is responsible for transferring the study to CTIS, however, we at the Compliance & Data Office (CDO) can offer assistance in getting started with the transfer and also answer questions along the way. 

The transfer counts as a new application but is based on already approved documentation. It can take several months to get the application approved in CTIS, so it is important to submit the application by 31 August 2024 to ensure processing time.

Please note that a transfer costs the equivalent of a new application, but it is possible to apply for a fee reduction. You can read more about application fees and costs on the Swedish Medical Products Agency's website. Läkemedelsverkets hemsida

Trials that have an ongoing amendment application in EudraCT cannot be transferred to CTIS until the review is completed.

What do I need to do as PI of an ongoing trial?

If you have an ongoing trial that will/may be active after 30 January 2025, you need to transfer the study to CTIS. 

  • You first need to create an account with EMA (if you do not already have one) to be able to log in to CTIS. Du behöver först skapa ett konto hos EMA (om du inte redan har det) för att kunna logga in i CTIS
  • Next, you will need an EUCT number (study number). This can be obtained by contacting us at Därefter behöver du ett EUCT-nummer (studienummer). Det får du genom att kontakta oss på
  • Fill in the application form and submit it. 
  • If you are several people who will have access to the study, you as PI can then add other researchers to your study in CTIS.