5 Common Clinical Trial Site Failures

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. Support the show

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