CTIS - applications for clinical trials of medicinal products
UCR provides support to researchers and investigators at Region Uppsala and Uppsala University.
Applications for approval of clinical trials of medicinal products are submitted in CTIS (Clinical Trials Information System) in accordance with the EU Clinical Trials Regulation (CTR 536/2014).
Region Uppsala and Uppsala University use a centralised application process when acting as sponsor for clinical trials of medicinal products.
This means that the responsible investigator must contact UCR’s support function to register the study in CTIS before the application can be initiated.
Read more: Medicinal products for human use – Swedish Medical Products Agency
The CTIS application process involves a single submission to both the Swedish Medical Products Agency and the Swedish Ethical Review Authority (or corresponding authorities in other EU countries).
Applications are submitted through the CTIS electronic portal.
UCR CTIS support
På uppdrag av Region Uppsala och Uppsala universitet har UCR den administrativa rollen att bevilja inträde till CTIS-plattformen.
If you need further support with your application, you can indicate this in the application form. UCR will then contact you to clarify what support is required.
Level 1 – The researcher or investigator manages the application
UCR provides funded advisory support to help you find application templates and review your application before submission, to identify any missing information.
Level 2 – UCR provides practical support
UCR can assist with uploading documents, completing the application and monitoring communications from authorities, as well as responding to queries.
UCR can also review study protocols and patient information, or assist in drafting these documents. This type of support is provided on a fee basis.
CTIS access (EMA account)
To log in to CTIS, you need an EMA account. If you already have an account from other EMA services (such as SPOR, Eudralink or EudraCT), you can use the same login credentials.
If you do not have an account, or need help with your login details, please visit the EMA support pages.
Biobank applications must be submitted at the same time as the CTIS application to: kliniskaprovningar@biobanksverige.se
If your study involves existing healthcare samples, contact the relevant pathology departments via the services available at biobanksverige.se well in advance to ensure that sufficient material is available and that the required documentation is completed correctly.
Log in to CTIS
Access CTIS at:
https://euclinicaltrials.eu/ct-sponsor-services/login
CTIS demo videoklipp
Det finns videoklipp som visar hur CTIS fungerar:
CTIS Demo part 1