How to Submit a Clinical Trial Application in CTIS?
Submitting a clinical trial application in the Clinical Trials Information System (CTIS) is now a crucial and mandatory step for starting a clinical trial within the European Union, as outlined in European Parliament and Council Regulation (EU) No. 536/2014. CTIS serves as a central, unified platform that allows simultaneous submission, evaluation, and further management of clinical trials across all participating member states. Although this process is often perceived as complex, its structure has been designed logically and transparently, provided that the documentation is properly prepared and the system's functioning is well understood.
The application process begins with gaining access to CTIS through an EU Login account and assigning appropriate roles to users on the Sponsor and/or CRO side. Then, a new clinical trial application is created, and basic administrative information is filled in, such as the study title, phase, target population, and planned geographical scope. A key component is the division of documentation into two parts: Part I, common to all participating countries, and Part II, which is prepared individually for each country. Part I includes, among others, the study protocol, investigator brochure, investigational medicinal product dossier (IMPD), and benefit-risk analysis, while Part II focuses on local aspects, such as informed consent forms, participant information, investigator qualifications, and data on research centers.
After uploading the documents and assigning member states, the Sponsor designates a Reporting Member State (RMS) to coordinate the evaluation of Part I of the application. The CTIS system allows for an internal validation of data completeness, reducing the risk of rejection for formal reasons. The entire application submission and subsequent evaluation process takes place within one tool, ensuring full transparency of the study's status, regulatory timelines, and ongoing communication with competent authorities and ethics committees. Any questions, requests for additional information, and responses from the Sponsor are managed directly within the system, significantly improving and organizing the regulatory process.
A properly prepared CTIS application not only fulfills a legal obligation but also represents a real investment in the smooth start of a clinical trial. A consistent, complete, and ICH GCP-compliant documentation minimizes the number of regulatory queries, shortens evaluation time, and enhances the Sponsor's credibility. Increasingly, CTIS is seen as a strategic tool that, when used correctly, enables effective management of multinational studies and helps mitigate regulatory risks during the project planning stage.
If you want to ensure that your CTIS application is prepared correctly, consistently, and in accordance with the latest regulatory requirements, contact our experts for a consultation. We can help translate complex regulatory demands into a safe and efficient clinical trial registration process.
