SOCRA CCRP Practice Exam

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What must the 'General Information' section of the protocol explicitly include?

Table of contents
Name/contact for medical expert
Data safety monitoring plan
Adverse events

The correct answer is: Name/contact for medical expert

The 'General Information' section of the protocol will include the basic details about the study, including the title and purpose. It should also include information about the investigators and study personnel involved. Therefore, it is important to also have the name and contact information for the medical expert leading the study in this section. It is only logical that the other options are incorrect because they do not explicitly relate to the basic details and personnel of the study. While a table of contents may be helpful, it is not necessary for this section. The data safety monitoring plan and adverse events may be included in other sections of the protocol, but they are not specific to the general information of the study.