European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 22, 2022, by updating the below documents in Module 08- Evaluate a clinical trial application- Assessment and decision-making:
- Step-by-step guide: How to evaluate a substantial modification clinical trial application – Module 08 (v1.1): It includes updated information for submission of final assessment and report (FAR) in the section of CTIS insights
- Quick guide – Decision: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – Module 08 (v1.3): It includes updated information about submission of decision for Member State Concerned (MSC) users in the section of ‘Process to submit the Decision’
- FAQs: How to evaluate an Initial Clinical Trial Application: Assessment and Decision – Module 08 (v1.3): The questions and answers that are added or revised in this version are –
- Section 2.17: This section was revised by adding information for documents to be provided in FAR in case of substantial modifications
- Section 4.3: This section was revised by adding information for the tasks to be performed in the decision phase in case the sponsor had applied for a deferral
- Section 4.6: This section was newly added providing information if any standard European forms must be filled while submitting a decision