The Clinical Trials Information System
Is the single entry point for clinical trial data in the European Union. It supports the harmonisation of the submissions and assessments.
It is composed of two distinct workspaces with secure access for authorities and sponsors and a public facing website with information for the general public. The secure interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries are conducted in this first workspace throughout the lifecycle of a clinical trial. National competent authorities and ethical committees use CTIS to collaborate on the evaluation and authorisation of a clinical trial in several EU/EEA countries.
It has the following functionalities:
- Manage users and user roles
- Compile clinical trial applications for new and updated trials
- Cross-reference to product documents in other clinical trials
- Submit clinical trial applications for assessment by Member States · Identify alerts and notifications for ongoing trials in CTIS
- Respond to requests for information and view deadlines
- Search and access clinical trials
- Issue notifications related to key milestones in the trial lifecycle (e.g. start of recruitment, end of recruitment)
- Record clinical trial results
- Submit annual safety reports
It is for the following target users:
- Clinical trial sponsors
- Marketing authorisation applicants and holders
- Other organisations involved in running clinical trials
For more information peruse the resources made available by the European Medicines Agency (EMA). A few key resources to investigate include: