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5 Common Clinical Trial Site Failures
Manage episode 457646172 series 3506216
Darshan Kulkarni द्वारा प्रदान की गई सामग्री. एपिसोड, ग्राफिक्स और पॉडकास्ट विवरण सहित सभी पॉडकास्ट सामग्री Darshan Kulkarni या उनके पॉडकास्ट प्लेटफ़ॉर्म पार्टनर द्वारा सीधे अपलोड और प्रदान की जाती है। यदि आपको लगता है कि कोई आपकी अनुमति के बिना आपके कॉपीराइट किए गए कार्य का उपयोग कर रहा है, तो आप यहां बताई गई प्रक्रिया का पालन कर सकते हैं https://hi.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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