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EMA Clinical Trials Information System - Sponsor user training programme
- — Welcome and Introduction
- — Overview of CTIS components & functionalities, sponsor user access management, sponsors roles and permissions,
- — Workload management - create, submit initial application, respond to Request For Information (RFI)
- — Update an initial application - substantial & non-substantial modification, manage a clinical trial through CTIS
- — Sponsor view, search and download options, create & submit an Annual Safety Report (ASR), Clinical Study Report (CSR) submission