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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