Glossary, CRG, NHLBI, NIH

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

Principal Investigator (PI)
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.

and IRB

Institutional Review Board (IRB)
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).

to formal monitoring boards.

In some cases, a Data Coordinating Center ( DCC

Data Coordinating Center (DCC)
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.

) 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

Data and Safety Monitoring Board (DSMB)
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).

) or Observational Monitoring Board ( OSMB

Observational and Safety Monitoring Boards (OSMB)
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.

), whether these are appointed by NHLBI

National Heart, Lung, Blood Institute (NHLBI)
a NIH

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.

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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Home » Clinical Research Guide» Management» How is data quality monitored?
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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 ? Study Closure Tools & Training Glossary	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 Principal Investigator (PI) 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. and IRB Institutional Review Board (IRB) 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). to formal monitoring boards. In some cases, a Data Coordinating Center ( DCC Data Coordinating Center (DCC) 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. ) 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 Data and Safety Monitoring Board (DSMB) 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). ) or Observational Monitoring Board ( OSMB Observational and Safety Monitoring Boards (OSMB) 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. ), whether these are appointed by NHLBI National Heart, Lung, Blood Institute (NHLBI) a NIH 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. 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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How is data quality monitored?