SOCRA CCRP Practice Exam

What does the summary information in the FDA progress report for drug studies typically include?

1. Rational for the study and estimated number of patients

2. List of subjects who died and subjects who dropped out due to adverse events

3. Clinical trials to be conducted in the 1st year

4. None of the above

The correct answer is: List of subjects who died and subjects who dropped out due to adverse events

Summary information in the FDA progress report for drug studies typically includes a list of subjects who died and subjects who dropped out due to adverse events. This is important information as it allows the FDA to monitor and evaluate the safety and efficacy of the drug being studied. Option A does not accurately describe the summary information, as it does not mention the results or outcomes of the study. Option C is also incorrect since it only mentions the trials to be conducted, rather than the results of the completed studies. Option D is incorrect because the FDA progress report for drug studies does include important information, such as the number of deaths and adverse events, for the purpose of evaluating drug safety and efficacy.