SOCRA CCRP Practice Exam

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What is part of the individual study information included in FDA progress reports for drug studies?

Summary of IND safety reports
Title, protocol number, and purpose
Rationale for study
Estimated number of patients in trials

The correct answer is: Title, protocol number, and purpose

Progress reports for FDA-regulated drug studies share part of the individual study information with the FDA and include the title, protocol number, and purpose of the study. Option A is incorrect because a summary of IND safety reports is not considered individual study information and is not usually included in progress reports. Option C is incorrect because the rationale for the study is also not usually included in progress reports as it is typically provided in the initial IND submission. Option D is incorrect because the estimated number of patients in trials is not necessarily considered individual study information and is not always required to be included in progress reports.