))
5 Common Clinical Trial Site Failures
Manage episode 457646172 series 3506216
المحتوى المقدم من Darshan Kulkarni. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Darshan Kulkarni أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.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.
150 حلقات
مشاركة
