On April 21st, 2021, EMA confirmed that CTIS is fully functional and meets the functional and ready to be launched. After its implementation, the Clinical Trials Information System will be the single-entry point for submitting clinical trial information in the EU.
What does the introduction of CTIS mean for clinical trials in the EU?
The Clinical Trials Information System (CTIS) is an information technology tool whose use will be mandatory for all new clinical trials under the Clinical Trials Regulation (CTR 536/2014/EU) after January 31st 2022. The Regulation is meant to harmonise and increase efficiency for clinical trials, with a single application portal and database for all trials conducted in the EU.
After its implementation, CTIS will be the single-entry point for submitting, assessing, authorising, supervising and reporting a clinical trial in all Member States of the EU. The idea is that the Clinical Trial Information System will foster better transparency and collaboration across borders within the EU countries. The CTIS will comprise a public website, which will host detailed information on clinical trials and the outcomes of the clinical trials that are conducted in the EU.
The new Clinical Trial Regulation will repeal the existing Clinical Trial Directive 2001/20/EC as well as any national legislation that was put in place to implement the Directive. It will also apply to trials authorised under the previous legislation if they are still ongoing three years after the Regulation has come into operation.
How to prepare for the implementation of the CTIS?
The key concepts for the new Clinical Trials Information System preparation include:
- Clinical Trial Regulation 536/2014/EU basics
- Organisation Management Service (OMS) requirements
- Extended EudraVigilance medicinal product dictionary (XEVMPD) requirements
- Identify “CTIS personas” within a company for training purposes
- Identify role and permission strategies within a company
- Evaluate clinical trial workflow and procedures to map to new Clinical Trials Information System functionality and day to day use
- Identify strategies for the transition period for existing and/or new trials
- Identify local requirement needs in addition to centralised CTIS functions
- Transparency requirements and strategy
How Asphalion can help you facilitate the implementation of the CTIS
Asphalion has been part of the EMA Clinical Trial Information System (CTIS) stakeholder meetings and also as a CTIS Master Trainer. As such we are closely involved in the implementation of the clinical trial regulation and can therefore offer you valuable support and information throughout the full process.
In addition, Asphalion has prepared a clear CTIS timeline, which you can download for free by completing the form below.
For any further questions on CTIs, please contact us directly at: [email protected]
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