WHO Draft Data Integrity Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] The World Health Organization (WHO) has released a draft guidance on “Good Data and Record Management Practices.”  The background section in the 35-page document notes that “implicit in the assessment and review process” of drug application data “is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable.”  It further notes that “in recent years the number of observations made regarding good data management practices …has been increasing,” pointing to the need for further industry guidance.  In addition to the background and an introduction, the draft includes sections on: ● aims and objectives of the guidance ● glossary ● principles ● quality risk management to ensure good data management ● management governance and quality audits ● contracted organizations, suppliers, and service providers ● training in good data and record management ● good documentation practice ● designing systems to assure data quality and reliability ● managing data and records across the data lifecycle ● addressing data reliability issues, and ● references and further reading.  The comment period ends on November 30, 2015.

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