SOCRA CCRP Practice Exam

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What should be described in the protocol's Withdrawal criteria section?

Inclusion/Exclusion criteria
When/how to withdraw subjects, type/timing of data collections for withdrawn subjects, and follow-up details
Details about the Independent Ethics Committee
Financial aspects of the trial

The correct answer is: When/how to withdraw subjects, type/timing of data collections for withdrawn subjects, and follow-up details

The Withdrawal criteria section in a protocol should contain information about when and how to withdraw subjects from the trial, the type and timing of data collection for withdrawn subjects, and any follow-up details. This section is important as it outlines the necessary steps for withdrawing a subject and ensures that the data collected from them is handled properly. Including information about the Independent Ethics Committee or financial aspects of the trial would not be relevant in this section and may confuse or distract from the important information about subject withdrawal.