Regulators have issued guidance documents advocating for the use of risk-based and fit for purpose approaches over a decade ago. The Good Clinical Practice guidance (i.e., ICH E6) was updated in 2016 to reinforce the direction and introduce Quality Tolerance Limits (QTLs). More recently, the long-awaited guidance on General Considerations for Clinical Studies (ICH E8) is further clarifying the expectations by focusing on two foundational risk-based principles which are Quality by Design (QbD) and Critical to Quality (CtQ) Factors.
Many of those principles apply directly to Clinical Data Management. If you are waiting for some directions to shift your Clinical Data Management strategy toward risk-based processes, this topic brief is a good place to start.
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