In order to make the information about safety reporting in CTR studies more accessible, the webpages concerning this subject have been updated. There have been no changes in legislation.
The structure and layout of the pages have been altered. A page with general information on safety reporting leads you to pages with specifics on SUSARs, ASR (annual safety reporting) and SaMS (Safety assessing Member States).
The language has been simplified and additional explanations have been added where possible. A flowchart for CTR studies has been added, similar to the flowcharts available for WMO, MDR and IVDR studies.
In addition, frequently asked questions about the simplified ASR template intended for investigator-initiated studies have been added.