SOCRA CCRP Practice Exam

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Which item is NOT included in the 'Background Information' section of the protocol?

  1. Findings from clinical trials

  2. Table of contents

  3. Route of administration, dosage, regimen and treatment period for IP

  4. Statement of compliance with protocol, GCP and applicable requirements

The correct answer is: Table of contents

The Background Information section of a protocol typically includes important details about the research and rationale for the study, such as previous findings, disease information, and objectives. It usually does not include a Table of Contents because that is more of an organizational element rather than directly related to the research itself. Findings from clinical trials, route of administration, dosage, regimen, and treatment period for the investigational product, and statement of compliance with protocol, GCP, and applicable requirements are all important aspects that are usually included in the Background Information section. Therefore, B is the incorrect answer.

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