SOCRA CCRP Practice Exam

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When does subject discontinuation require reporting to the IRB?

For all types of studies
Never
If trial is greater than minimal risk and IRB requires notification
Only for pediatric studies

The correct answer is: If trial is greater than minimal risk and IRB requires notification

All study withdrawals should be reported to the IRB regardless of the type of study. However, subject discontinuation only requires reporting when the study is greater than minimal risk and the IRB specifically requires notification. This means that for studies with minimal risk or low-risk studies that do not fall under the IRB's notification requirements, subject discontinuation does not need to be reported. Option A is incorrect because all types of studies may not have minimal or greater risks. Option B is incorrect because, as mentioned previously, study withdrawals should always be reported to the IRB. Option D is incorrect because subject discontinuation reporting is not limited to just pediatric studies.