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5 Common Clinical Trial Site Failures
Manage episode 457646172 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.
Darshan discusses the five most common clinical trial site issues:
1. Failure to Follow Investigational Plan: Treating clinical trials like routine medical practice instead of strictly following the protocol can lead to serious issues.
2. Inadequate and Inaccurate Records: The FDA emphasizes that if it’s not documented, it didn’t happen. Inaccurate records can lead to compliance problems.
3. Inadequate Drug Accountability: Not knowing where your investigational product has gone is a major issue. The FDA expects thorough tracking and accountability.
4. Failure to Obtain and Document Subject Consent: Consent issues are a big problem, with 9% of clinical trial issues related to improper or insufficient documentation of consent.
5. Inadequate Subject Consent: Obtaining consent is critical, and inadequate consent is a common and problematic issue.
For help with clinical trial compliance, contact Darshan.
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