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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

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.

Compensation for subjects

Recruitment strategies

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