Answers to frequently asked questions regarding the new form of annual safety report, the DSUR, have been harmonised on the European level by the Clinical Trial Facilitation Group (CTFG). Questions covered in the document concern reference safety information, special conditions of investigational medicinal product or clinical study, reporting period like start, stop, coordination and alignment e.g. with marketed products or previous annual reporting periods. It is intended to publish the question and answer document, as below, on the HMA (CTFG) homepage:

http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2011_12_22_Q___A_DSUR.pdf