SOCRA Certified Clinical Research Professional (CCRP) CCRP Question # 26 Topic 3 Discussion
CCRP Exam Topic 3 Question 26 Discussion:
Question #: 26
Topic #: 3
A research site was invited to participate in an investigational drug study. Which of the following parties is responsible for determining the risk-benefit ratio at the site?
Therisk-benefit ratiois a core responsibility of the IRB/IEC.
21 CFR 56.111(a)(2):“Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”
ICH E6(R2) 3.1.2:IRB/IEC must safeguard rights, safety, and well-being of subjects, with special attention to risk-benefit evaluation.
Investigators (A) provide medical judgment but do not formally approve the risk-benefit balance. Sponsors (D) design studies but must submit to IRB for independent review. Legal counsel (C) is not part of the scientific/ethical evaluation.
Thus,IRB/IEC is directly responsible for approving the risk-benefit ratio.
[References:, 21 CFR 56.111(a)(2)., ICH E6(R2), §3.1.2., ]
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