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How is data quality monitored?

Data quality is essential to ensuring that study data is reliable and complete in order to accurately assess the safety and effectiveness of an experimental therapy. This often requires input from experts on developing data collection forms and systems, performing data quality audits and preparing data monitoring reports. Monitoring of studies is described in more detail in “Data and Safety Monitoring Plans” in which different levels of monitoring are discussed from monitoring by the PI and IRB to formal monitoring boards.

In some cases, a Data Coordinating Center ( DCC ) will be an integral part of a project especially in multi-center and Network programs. For those projects without a designated DCC, investigators must carefully consider who will prepare reports for a Data Monitoring Committee (DMC), Data and Safety Monitoring Board ( DSMB ) or Observational Monitoring Board ( OSMB ), whether these are appointed by NHLBI or not.

Sample reports may be found on the University of Wisconsin's Statistical Data Analysis Center website. You must judge the suitability of the samples to your specific project.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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