SOCRA CCRP Practice Exam

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What should be included in the first section of the FDA progress report for drug studies?

Individual study information
Summary information
General investigational plan
Conclusion of findings

The correct answer is: Individual study information

Individual study information should be included in the first section of the FDA progress report for drug studies because it provides detailed and specific data on each study that was conducted. This information is essential for the FDA to understand the progress and results of the drug studies. Summary information (option B) provides a brief overview of the entire drug study progress, but it does not go into the depth necessary for the FDA to evaluate the studies. General investigational plan (option C) outlines the overall plan for the drug studies, but it does not provide specific data on individual studies that are required in the first section. Conclusion of findings (option D) should be included at the end of the FDA progress report, not in the first section. This section should summarize the overall findings of the drug studies, not individual study information.