SOCRA CCRP Practice Exam

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For device trials, to whom must sponsors submit semi-annual progress reports in addition to the annual report under a treatment IDE?

To all reviewing IRBs and FDA
To the principal investigator only
To the ethics committee only
To the department of health

The correct answer is: To all reviewing IRBs and FDA

Device sponsors must submit semi-annual progress reports in addition to the annual report to all reviewing IRBs and the FDA. This is because all regulatory bodies involved in the oversight and approval of the device trial should be kept informed of the progress and any potential issues that may arise. This level of communication and transparency is necessary to ensure the safety and ethical conduct of the trial. Neither the principal investigator only, the ethics committee only, nor the department of health are sufficient recipients for these reports, as they do not encompass the full range of regulatory entities involved.