SOCRA CCRP Practice Exam

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Which of the following is commonly added to protocols by sponsors but not explicitly recommended by ICH GCP?

Trial objective and purpose
Data safety monitoring plan
Selection and withdrawal of subjects
Statistics

The correct answer is: Data safety monitoring plan

The data safety monitoring plan is commonly added to protocols by sponsors but not explicitly recommended by ICH GCP. While all of the other choices are important aspects of a proper protocol, they are all explicitly recommended by ICH GCP. The data safety monitoring plan is often added because sponsors want to ensure the safety of their participants, but it is not explicitly required by ICH GCP. Keeping track of statistics, selection and withdrawal of subjects, and defining the trial objective and purpose are all outlined in ICH GCP guidelines and are critical components of a well-designed protocol. However, the exact details and implementation of a data safety monitoring plan may vary depending on the specific trial and sponsor preferences.