European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 05, 2022. A new version of FAQs: How to evaluate a CT application (v1.4) was added in Module 06- Evaluate a clinical trial application: Selection of reporting Member State (RMS) and validation of the clinical trial application:
The questions and answers that are added in this version are –
- Section 4.9: This section provides information on uploading ‘documents not for publication’ with screenshots for better understanding.
- Section 4.10: This section provides information on raising a consideration for an application section or document that is not included in the ‘Application section and document’ drop-down list.