Reply To: DEVELOPMENT SAFETY UPDATE REPORT

[Eldin Rammell]

Remember that a DSUR is not a trial-specific document (unless you only have 1 clinical trial in development). For this reason, many sponsors do not file the DSUR (or PSUR) in the TMF but rather file it in the Pharmacovigilance system. However, the TMF will hold any trial-specific notifications related to the DSUR e.g. notification to Ethics Committee.