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Who approves my data monitoring plan?

Though your monitoring plan has gone through peer review, you will work with 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.
to make the final decision about safety monitoring before you send the protocol 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).
or before you begin the study.  Discuss this topic with your Program Director 
Program Director
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Official.
early in the process and decide on an adequate plan. Then submit your protocol with the data monitoring plan to your IRB for review.  NHLBI requires that your IRB approve the monitoring plan as well as the protocol, consent forms and other documents.



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

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