European Medicines Agency updated the page Clinical Trials Information System: training program, on July 26, 2021, by adding the below documents in CTIS Training Module 18 (How to submit an annual safety report and respond to related RFIs):
- Step-by-step guide: How to submit an annual safety report and respond to related RFIs (PDF): It provides step-by-step guidance on how to create and submit annual safety report (ARF). It also provides guidance on how to respond to RFIs during the assessment of an ASR with insights and screenshots.
- Instructor’s Guide: How to submit an annual safety report and respond to related RFIs (PDF): It contains an overview on how to create and submit the ARF form in CTIS and guidance for trainers for disseminating the training materials.
- FAQs: How to submit an annual safety report and respond to related RFIs (PDF): It contains questions regarding the sections, creation, submission, assessment, the roles and permissions of ARF form and questions for RFIs related to ARF with diagrams for better understanding.
- Process Puzzle: How to submit an annual safety report and respond to related RFIs (PPT): It includes exercises useful for understanding steps for submission of ARF with different case scenarios and its solutions in pictographic form.