SOCRA CCRP Practice Exam

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What does the ICH GCP guideline recommend should be included in the Trial Design section?

Details about the sponsor and investigators
Primary/secondary endpoints, type/design of trial, and other specific trial design details
Compensation for subjects
Recruitment strategies

The correct answer is: Primary/secondary endpoints, type/design of trial, and other specific trial design details

The ICH GCP guideline recommends that the Trial Design section includes details about primary/secondary endpoints, as well as the type/design of the trial and other specific trial design details. Option A is incorrect as details about the sponsor and investigators would typically be included in the Introduction section. Option C is incorrect as compensation for subjects would be addressed in the Informed Consent section. Option D is incorrect as recruitment strategies would be discussed in the Recruitment and Enrollment section. Overall, the Trial Design section is specifically focused on providing details about the study design and objectives.