Wednesday, December 8, 2010

Top 5 GCP violations

- Protocol non-adherence: Failure to follow the protocol or notify the IRB of problems
- Clinical Records not well documented: They are incomplete, inaccurate or out-of-date. 483 bait
- Informed Consent problems: Incomplete, language issues, back dated, process absent or in question
- Investigational product supply chain accountability: Failure to account for each and every product/pill.
- Adverse Event collection and reporting: from severity determination to reporting errors occur

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