SOCRA CCRP Practice Exam

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What type of findings must be reported in narrative format in IND safety reports for drug studies?

Findings from clinical studies only
Findings from animal studies only
Overall findings or pooled analyses from various types of studies
Only findings related to adverse drug reactions

The correct answer is: Overall findings or pooled analyses from various types of studies

Narrative format in IND safety reports for drug studies requires an overall summary of findings from various types of studies, such as clinical and animal studies. Option A is incorrect because it only includes findings from clinical studies, which may not capture the full picture of drug safety. Option B is incorrect because it only includes findings from animal studies, which also may not accurately represent the safety of the drug in humans. Option D is incorrect because it only includes findings related to adverse drug reactions, which is important but not the only type of finding that needs to be included in a narrative format. Option C is the best answer as it encompasses all relevant findings from different types of studies to provide a comprehensive report on the safety of the drug.