Safety Reporting Flowchart: Periodic Line Listing, DSUR and Clinical Study Report
Safety Reporting Flowchart: Periodic Line Listing, DSUR and Clinical Study Report. The texts are derived from the European Clinical Trial Directive 2001/20/EC and the detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (2010/C 82/01). If necessary (e.g. readability) content was modified for instructional and educational purposes.