CITI Training Practice Exam

Question: 1 / 400

What does the ICH E6 guideline require to be included in a consent form regarding treatment arms?

Only the description of each arm

Probability of patient allocation to each arm

Description of each arm, the likelihood of being assigned to each study arm, and explanation of the subject's responsibilities

The ICH E6 guideline requires that the consent form includes a description of each arm, the likelihood of being assigned to each study arm, and an explanation of the subject's responsibilities. Option A is incorrect because it does not cover the likelihood of being assigned to each study arm and the subject's responsibilities. Option B is incorrect because it only mentions the probability of patient allocation, but does not include the description of each arm or the subject's responsibilities. Option D is incorrect because it is not a requirement of the ICH E6 guideline and is not relevant to the treatment arms.

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