SOCRA CCRP Practice Exam

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What regulations must Significant Risk studies follow?

Follow all IDE regulations and have FDA approval
Follow abbreviated IDE regulations
Need only IRB approval
Consult with FDA but no formal approval needed

The correct answer is: Follow all IDE regulations and have FDA approval

Significant Risk studies must follow all IDE regulations, as they involve testing of medical devices and pose potential risks to human subjects. This includes obtaining FDA approval and following all necessary steps and guidelines for conducting the study. Options B, C, and D are incorrect because they do not fully encompass the necessary regulations and steps required for conducting these types of studies. While IRB approval is also important for ethical considerations, it is not sufficient for significant risk studies without following all IDE regulations and obtaining FDA approval. Simply consulting with the FDA is not enough, as formal approval is necessary to ensure the safety and ethical conduct of these studies.