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Why Adverse Events Go Unreported in Clinical Trials
Manage episode 429570295 series 3506216
Indhold leveret af Darshan Kulkarni. Alt podcastindhold inklusive episoder, grafik og podcastbeskrivelser uploades og leveres direkte af Darshan Kulkarni eller deres podcastplatformspartner. Hvis du mener, at nogen bruger dit ophavsretligt beskyttede værk uden din tilladelse, kan du følge processen beskrevet her https://da.player.fm/legal.
In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disruptions in menstrual cycles, violent episodes, or even deaths were not reported. While some cases were eventually identified, others went unnoticed, highlighting the importance of vigilant compliance. Sites should be aware that regulatory bodies like the FDA and DOJ closely monitor for such violations.
Need assistance with your trial compliance? Reach out to Darshan at Darshan@kulkarnilawfirm.com.
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