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Management

Managing a clinical research grant 

Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the 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 or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
involves much more than just enrolling patients into a study.  There are many activities that you, as 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.
, are responsible to do.  You are expected to submit on-going reports (to your 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).
and NHLBI 
National Heart, Lung, Blood Institute (NHLBI)
a NIH 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.
), monitor subjects and study progress, budget and key personnel and communicate with many parties related to your project.  This section will help you to better understand which activities are involved in managing your clinical research grant and will answer the following questions:



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

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