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.
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
Principal Investigator (PI) and IRB
a qualified person designated by an applicant institution to direct a research project or program, oversee scientific and technical aspects of a grant and the day-to-day management of the research.
Institutional Review Board (IRB) to formal monitoring boards.
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
In some cases, a Data Coordinating Center ( DCC
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
provides support for large studies and focuses on central training in research methods, statistical leadership, data collection and management. Also known as Coordinating Center or Biostatistical Center.
Data and Safety Monitoring Board (DSMB) ) or Observational Monitoring Board ( OSMB
an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC). (see Data and Safety Monitoring Policy
Observational and Safety Monitoring Boards (OSMB) ), whether these are appointed by NHLBI
independent monitoring group whose principal role is to regularly monitor regularly data from large or complex observational studies and to review and assess the performance of its operations. Whether an OSMB is needed is determined on a case-by-case basis by NHLBI.
National Heart, Lung, Blood Institute (NHLBI) or not.
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage
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