SOCRA CCRP Practice Exam

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

1. Device Verification Agreement

2. Investigator Assurance Agreement

3. Investigator Agreement

4. Device Study Protocol

The correct answer is: 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.