CITI Training Practice Exam

Which of the following is a goal of the ICH E6 standard?

1. To ensure trial data is destroyed after 5 years

2. To assure the rights, well-being, and confidentiality of trial subjects are protected

3. To guarantee a profit from drug sales

4. To fast-track drug approval

The correct answer is: To assure the rights, well-being, and confidentiality of trial subjects are protected

The International Conference on Harmonization (ICH) E6 standard is a set of guidelines for good clinical practice in clinical trials. One of its main goals is to protect the rights, well-being, and confidentiality of trial subjects. This is achieved by establishing ethical and scientific standards for conducting clinical trials, as well as requiring regular monitoring and reporting of trial data. Option A is incorrect because the ICH E6 standard actually requires that trial data be maintained and accessible for a minimum of 25 years. Option C is incorrect because the ICH E6 standard does not prioritize profit from drug sales but rather focuses on ensuring the safety and efficacy of investigational drugs. Option D is incorrect because the ICH E6 standard does not promote or advocate for fast-track drug approval, but rather emphasizes the importance of thorough and ethical clinical trials. Therefore, the most appropriate goal of the ICH E6 standard is option