This guidance consolidates existing normative principles and gives further detailed illustrative implementation guidance to bridge the gaps in current guidance. Additionally, it gives guidance as to what these high-level requirements mean in practice and what should be demonstrably implemented to achieve compliance.
These guidelines highlight, and in some instances clarify, the application of data management procedures. The focus is on those principles that are implicit in existing WHO guidelines and that if not robustly implemented can impact on data reliability and completeness and undermine the robustness of decision making based upon that data.
Current status of document: DRAFT FOR COMMENT (comments must be sent until 30 November 2015 to WHO).
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Training Data Integrity with German inspector – including MHRA & WHO Data Integrity Definitions and Guidance documents – 20. October 2015 – Darmstadt, Germany