SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

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What is the equivalent of a Form FDA 1572 for device studies?

Device Verification Agreement

Investigator Assurance Agreement

Investigator Agreement

The equivalent of a Form FDA 1572 for device studies is an Investigator Agreement. Option A, Device Verification Agreement, is incorrect because it pertains to the verification of device design and manufacturing processes, not clinical studies. Option B, Investigator Assurance Agreement, is incorrect because it pertains to the assurance of compliance with applicable regulations, not the submission of study applications. Option D, Device Study Protocol, is incorrect because it pertains to the specific plan for conducting a clinical study, not the submission of study applications. Therefore, option C is the only correct choice.

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Device Study Protocol

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