SOCRA CCRP Practice Exam

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Which of the following is NOT recommended by ICH GCP to be included in a protocol?

  1. Statistics

  2. Data quality assurance

  3. Treatment of subjects

  4. Trial design

The correct answer is: Data quality assurance

ICH GCP (International Conference on Harmonisation of Good Clinical Practice) provides guidelines and standards for the design, conduct, and reporting of clinical trials. These guidelines aim to protect the rights and well-being of trial subjects and ensure the integrity of trial data. Therefore, all of the other options (A, C, D) are recommended to be included in a protocol, as they are important aspects of a clinical trial. Option B, Data quality assurance, is NOT recommended to be included in a protocol by ICH GCP, as it is the responsibility of the sponsor to ensure data quality through other means such as monitoring and audits.

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