WHO Releases Draft Guidance on Global Data Integrity
Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices.
According to the guidance, organizations need to first establish an organizational structure that includes written policies and procedures documenting processes to prevent and detect situations that may have an impact on data integrity.
Senior management has the ultimate responsibility to ensure an effective quality system is in place in which employees are encouraged to communicate data failures and mistakes.
Quality units also should report on metrics related to data integrity to help identify opportunities for improvement. These include tracking and trending invalid and aberrant data, as well as a regular review of audit trails and routine inspections.
WHO also recommends monitoring contract organizations, as well as tracking and trending associated quality metrics for those sites.
Finally, management needs to ensure that all personnel are trained in data integrity polices and agree to abide by them, WHO says.
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