By Steven Beales
Even during normal times, the usual approach to safety reporting places a heavy burden on sites. Sponsors inundate them with safety notifications, many of which are unnecessary. As a result, sites become overwhelmed and miss critical patient safety information, which become lost in a mountain of paperwork that includes unnecessary notices. Moreover, this practice is contrary to health authority and country-level rules and regulations.
Once you overlay these issues with the current pandemic-driven uncertainty and staff shortages, the depth and breadth of the challenge becomes apparent.
And while it’s true that the Food and Drug Administration and other regulatory bodies are loosening up certain requirements during the pandemic, they are allowing no slack in the reporting of unexpected safety events. Suspected Unexpected Serious Adverse Reactions (SUSAR) letters still must go out, generally within 15 days after the sponsor is notified of the event – seven days in case of death or a life-threatening issue.
This article outlines many ways sponsors and sites can align for a more streamlined and efficient safety letter distribution process.