CITI Training Practice Exam

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If planning to market drugs outside the US, what guidance must a Principal Investigator (PI) follow while conducting the clinical trial?

FDA Regulations
EU Directive 2001/20/EC
ICH E-6 Good Clinical Practice
GMP Guidelines

The correct answer is: ICH E-6 Good Clinical Practice

A possible explanation could be When conducting a clinical trial for drugs outside of the US, the Principal Investigator (PI) must follow the ICH E-6 Good Clinical Practice guidelines. These guidelines provide a globally accepted standard for conducting and managing clinical trials. Option A, FDA Regulations, may be relevant for clinical trials conducted within the US, but would not apply to trials conducted outside the US. Option B, EU Directive 2001/20/EC, may only apply to trials conducted in European Union countries and may not be applicable to other regions. Similarly, option D, GMP Guidelines, may only pertain to the production and manufacturing of drugs, but not the conduct of clinical trials. Therefore, the most appropriate and comprehensive guidance for conducting clinical trials outside of the US would be the ICH E-6 Good Clinical Practice guidelines.