SOCRA CCRP Practice Exam

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What is the reporting frequency for progress reports if the device is under a treatment IDE?

Monthly
Semi-annual progress reports and an annual report
Quarterly and an annual report
Only at the conclusion of the study

The correct answer is: Semi-annual progress reports and an annual report

Progress reports are required for any device under an investigational device exemption (IDE). These reports provide updates on the safety and effectiveness of the device during the course of the study. Since an IDE study can last for multiple years, it is important to have regular reporting to track progress and address any concerns. Option A (monthly) would result in too many reports, while option C (quarterly and annual) does not provide enough updates. Option D (only at the conclusion of the study) would not allow for monitoring and addressing any issues that may arise during the study. Therefore, option B (semi-annual progress reports and an annual report) strikes the right balance of regular reporting without being too frequent or infrequent.