In January of 2023, CTIS will become the required portal for all new and ongoing clinical trials in the European Union.
This whitepaper will cover these key topics:
- What is the CTIS (Clinical Trial Information System)
- What are the key takeaways of this new system?
- Privacy implications of the public documentation
- How to plan ahead for new technology requirements
Here is a short sample from the whitepaper...to view the complete guide, fill out the form below.
Navigating CTIS for EU Clinical Trials
An Overview of Technical and Process Implications for Sponsors
The CTIS will soon become mandatory for all sponsors running EU trials
While you may have heard of the CTIS (Clinical Trial Information System), its use will soon be mandatory for all new and ongoing clinical trials in the European Union. As of January 2023, sponsors will be required to submit EU clinical trial applications through this new online portal and database in an effort to consolidate, streamline, and increase transparency to European citizens.
CTR (Clinical Trial Regulation EU No 536/2014) replaced CTD (Clinical Trials Directive 2001/20/EC) in 2014. Since that time, CTIS has been developed and now it’s here to stay. However, while CTIS is intended to simplify the clinical trial submissions process, the new system presents several challenges for companies with new and existing EU trials to manage. From additional documentation to increased exposure of files, CTR compliance can seem overwhelming and even intimidating.
This paper will help you gain a better understanding of the changes dictated by CTR, to better prepare your company for using CTIS effectively.
Multiple submissions are being consolidated into one, under the CTR
When CTD was in effect, trial sponsors had to submit separate applications to NCA (National Competent Authorities) and EC (Ethics Committee) in each country of involvement before awaiting individual assessment and approval. This fragmented and long-winded process left much to be desired and has since been superseded by CTR (Figure 1).
One of the primary benefits of CTR to trial sponsors is the introduction of submission portal and database, CTIS. By submitting just one clinical trial application, the assessment and governing of EU trials will be better coordinated, maximizing efficiency and fostering innovation—particularly for multinational studies.
Submissions will now...
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