SOCRA CCRP Practice Exam

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What is included in the Adverse Events section of the protocol?

  1. A plan for public relations

  2. Safety parameters and adverse event reporting procedures

  3. Details about financial support

  4. A schedule of assessments

The correct answer is: Safety parameters and adverse event reporting procedures

The Adverse Events section of a protocol outlines the safety parameters and procedures for reporting any adverse events that may occur during the study. Option A, a plan for public relations, is unrelated to the purpose of this section and would not be included. Option C, details about financial support, may be included in the protocol but would be addressed in a separate section. Option D, a schedule of assessments, may also be included in the protocol but would be addressed in a different section as well. Therefore, the best and most complete answer is B, as it specifically addresses the purpose of the Adverse Events section.

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