A single electronic application for trial authorization will be made via the new Clinical Trials Information System (CTIS). The CTIS will contain the centralized EU portal and database for clinical trials. The European Medicines Agency (EMA) will set up and will maintain the CTIS in collaboration with the Member States and the European Commission. The CTIS complements the General Data Protection Regulation (GDPR), strengthening the security of personal data. It provides the legal basis for storing and processing personal data and is in addition to GDPR consent.
The Sponsor proposes a “Reporting Member State”, with clear timelines for evaluation and notification. The Member State then determines an appropriate body or bodies to be involved in the assessment, providing a single, combined regulatory and ethics authorization for the trial.
The application is made in two parts:
- Part 1 assessment, containing the common scientific documents e.g. application form protocol, investigator brochure etc.
- Part 2 assessment is the consideration of specific national or local factors e.g. liability, data protection, investigator sites etc.
The portal will also be used to report serious breaches, urgent safety measures (USMs), annual safety reports, the two required summary of results (one which should be understood by a lay person and the other a scientific report) and a full Clinical Studies Report (CSR).