SOCRA CCRP Practice Exam

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What regulations do Non-Significant Risk studies need to adhere to?

  1. Follow abbreviated IDE regulations, no FDA approval needed

  2. Must have FDA and IRB approval

  3. Are exempt from all regulations

  4. Must report to FDA prior to study start

The correct answer is: Follow abbreviated IDE regulations, no FDA approval needed

Non-Significant Risk studies are categorized under the "abbreviated" category in the FDA's Investigational Device Exemption (IDE) regulations. This means that they still need to adhere to certain regulations, but they do not require FDA approval before conducting the study. Options B, C, and D are all incorrect because they either require additional approvals or exemptions from regulations, which do not apply to Non-Significant Risk studies.

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