SOCRA CCRP Practice Exam

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What does the 'Background Information' section of the protocol NOT require?

  1. Name/description of Investigational Product

  2. Details of the data safety monitoring plan

  3. Findings from nonclinical studies

  4. Risks/benefits known

The correct answer is: Details of the data safety monitoring plan

The 'Background Information' section of the protocol is typically used to provide relevant context and rationale for the study, such as the scientific basis and justification for the research. This section would typically include the name and description of the investigational product, findings from nonclinical studies, and information on known risks and benefits. However, the details of the data safety monitoring plan would typically be included in a separate section of the protocol, as it pertains specifically to the monitoring and management of participant safety during the study. Therefore, the 'Background Information' section does not typically require details of the data safety monitoring plan.

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