SOCRA CCRP Practice Exam

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What should the 'General Information' section of the protocol include?

Risks/benefits known
Protocol #
Standard of Care
Magnitude of IP effect expected

The correct answer is: Protocol #

The 'General Information' section of the protocol should include the protocol number, as it serves as a unique identifier for the study and is necessary for referencing and tracking purposes. This section is not the appropriate place to include risks/benefits, standard of care, or the magnitude of the investigational product's effect. These elements should be included in other sections of the protocol that specifically address these topics. Additionally, those options are too specific and do not fall under the general information category that this section is meant to cover. Therefore, the protocol number is the only correct and relevant inclusion in this section.