SOCRA CCRP Practice Exam

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Which is a commonly used section in protocols by sponsors that is not directly recommended by ICH GCP?

  1. References

  2. Statistics

  3. Selection and withdrawal of subjects

  4. Table of contents

The correct answer is: Table of contents

A table of contents is often used in protocols by sponsors as a helpful guide for locating specific information within the document. It is not directly recommended by ICH GCP, as it is not included in the specific sections that ICH GCP recommends for the content of protocols. These recommended sections include background and rationale, objectives and purpose, trial design, selection and withdrawal of subjects, treatment of subjects, assessment of efficacy and safety, and statistical methods. References are also not specifically recommended by ICH GCP, as they are not considered essential for the conduct of clinical trials. Statistics, while important for the analysis of trial data, are not a recommended section in protocols, as they are often found in a separate statistical analysis plan document. Selection and withdrawal of subjects is a crucial component of trial conduct, but it is a recommended section by ICH GCP and therefore not the correct answer to

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