Clinical Research and GCP Update

Impact on E6(R3): Expect to have to identify Critical to Quality Factors • CQFs are basic set of factors relevant to ensuring study quality identified for each study. • Emphasis on factors that stand out as critical to study quality. • These quality factors are considered to be critical because, if their integrity were to be undermined by errors of design or conduct, the reliability or ethics of decision-making would also be undermined.

What are CQFs? Attributes of a study whose integrity is fundamental to the protection of study subjects, the reliability and interpretability of the study results, and the decisions made based on the study results.

See E8(R1) 3.2

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E8(R1): Risk Assessment

• Having identified the factors relevant to ensuring study quality • Determine the risks that threaten their integrity, the probability and impact of those risks and decide if they should be accepted or mitigated • If risks are to be mitigated − Necessary control processes should be put in place and communicated − Necessary action taken to mitigate those risks

3.2

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