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How do I comply with Good Clinical Practices (GCP)?
How do I manage changes to my grant?
How do I report amendments, suspensions and terminations?
Must I obtain continuing review from the IRB?
Who should monitor subject recruitment/retention?
How do I report adverse events?
How is data quality monitored?
What if I wish to add extra sites or studies to my project?
How do I manage my budget and when are reports expected?
What is HIPAA and how do I abide by the requirements?

Glossary Box

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 PIGlossary Term and IRBGlossary Term to formal monitoring boards. Research integrity and avoiding data error is discussed in Guidelines for Data Quality Assuranc e in Clinical Trials and Observational Studies.

In some cases, a Data Coordinating Center (DCCGlossary Term) 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 (DSMBGlossary Term) or Observational Monitoring Board (OSMBGlossary Term), 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.