))
5 Common Clinical Trial Site Failures
Manage episode 457646172 series 3506216
内容由Darshan Kulkarni提供。所有播客内容（包括剧集、图形和播客描述）均由 Darshan Kulkarni 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品，您可以按照此处概述的流程进行操作https://zh.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.
190集单集
分享
