The data generated from clinical trials tends to be more complete than that received through typical channels of spontaneous reporting. Likewise the steps for follow-up are often far easier to take. Nonetheless, you will need to demonstrate consistently that your reporting process is adequately specified and resourced to the task.
Additionally to the need for expedited reporting of SUSARs, Development Safety Update Reports (DSURs) should be submitted to regulatory authorities and Ethics Committees throughout the clinical trial or on request. The DSUR takes into account all new available safety information received during the reporting period.
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