SOCRA CCRP Practice Exam

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How often must sponsors submit progress reports in device trials to all reviewing IRBs?

Monthly
Quarterly
Biannually
At least yearly

The correct answer is: At least yearly

Progress reports must be submitted by sponsors annually to any reviewing IRBs, according to regulations set by the FDA. The other options are incorrect because reporting at monthly, quarterly, or biannual intervals would be too frequent and impose unnecessary burdens on both sponsors and IRBs. Therefore, yearly reports are required to ensure that the reviewing IRBs are kept informed of any new or unexpected adverse events and to monitor the overall progress of the device trial. Submitting reports less frequently may result in delays in addressing any potential safety concerns.