SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 29 Topic 3 Discussion
CCRP Exam Topic 3 Question 29 Discussion:
Question #: 29
Topic #: 3
The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).
45 CFR 46.109(f):“Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk.”
ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.
Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.
Thus, the correct answer isD (No such requirement).
[References:, 45 CFR 46.109(f) (Exempt and expedited reviews)., ]
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