European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on June 06, 2022, by adding new versions for the below documents in Module 08- Evaluate a clinical trial application: Assessment and decision-making and Module 19- CTIS for SMEs and academia:
- Quick guide – Part II: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – Module 08 (v1.3): The section for roles and permission was updated by updating the functionalities of the Assessor Part II preparer
- Quick guide – Introduction: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – Module 08 (v1.3): It was updated with some minor grammatical changes and by adding more information on how to use the quick guide
- Quick guide – Introduction: CTIS for SMEs and Academia – Module 19 (v1.3): It provides links for CTIS demonstration video recordings to issue notifications, and respond to ad hoc assessments and sponsors’ opinion requests. These recording also guides on submission of clinical trial application (CTA), non-substantial modifications, annual safety reports (ASR), results in summary, clinical study report (CSR), along with how to respond to the request for information (RFIs), and CTA RFIs.