European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme, on October 11, 2021, by adding the below documents in CTIS Training Module 20 (Assess an annual safety report):
- Instructor’s guide: Assess an annual safety report – Module 20: It provides an overview on assessment of an annual safety report (ASR) in CTIS as part of the supervision of a Clinical Trial (CT) for authorized users for disseminating the training materials.
- Step-by-step guide: Assess an annual safety report – Module 20: It provides detailed step-by-step guidance on how to assess an ASR (from the point of view of the safety assessing Member State), and how to create an request for information (RFI) as part of the assessment of an ASR.
- Crossword puzzle: How to assess an annual safety report – Module 20: It contains a crossword puzzle related to definitions and concepts on Module 20 with a solution.
- FAQs: Assess an annual safety report – Module 20: It provides answers to questions related to the ASR and its assessment, roles and permission, and process for creating the RFI related to an ASR.
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