SOCRA CCRP Practice Exam

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What is one of the six components of the general investigational plan included in FDA progress report for drug studies?

Estimated number of patients in trials
List of subjects who died
Frequent and most serious adverse events
Title and protocol number

The correct answer is: Estimated number of patients in trials

The other options are incorrect because they do not specifically relate to the general investigational plan included in the FDA progress report. Option B, a list of subjects who died, is not a component of the plan and would only be included in the report if there were any deaths during the study. Option C, frequent and most serious adverse events, is also not a component of the plan and would be listed separately in the report. Option D, title and protocol number, is important information but it does not pertain to the general investigational plan itself. Option A, estimated number of patients in trials, is a key component of the plan as it outlines the expected sample size for the study. This is important for understanding the statistical significance and power of the study, as well as potential recruitment and enrollment concerns.