Glossary, CRG, NHLBI, NIH

My study involves Medicare or third party support.

Your research may incorporate financial support from third parties. 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.

has issued guidance on Third Party Involvement in NHLBI-Sponsored Clinical Trials and other Population-Based Studies. It is important to discuss your plans to partner with a third party 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.

before your study begins in order to obtain proper approval from NHLBI, if necessary.

Medicare Coverage of Clinical Trials will give you information about the CMS

Centers for Medicare and Medicaid Services (CMS)
a federal agency under DHHS

Department of Health and Human Services (DHHS)
the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. (also known as HHS) Department of Health and Human Services Homepage

that administers the Medicare program, partners with states to administer Medicaid, surveys and certifies health care facilities and regulates all laboratory testing. CMS Homepage

policy on what Medicare will pay for during a clinical trial and how this might be accomplished.

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

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Home » Clinical Research Guide» Funding» My study involves Medicare or third party support
CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management 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 ? Study Closure Tools & Training Glossary	My study involves Medicare or third party support. Your research may incorporate financial support from third parties. 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. has issued guidance on Third Party Involvement in NHLBI-Sponsored Clinical Trials and other Population-Based Studies. It is important to discuss your plans to partner with a third party 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. before your study begins in order to obtain proper approval from NHLBI, if necessary. Medicare Coverage of Clinical Trials will give you information about the CMS Centers for Medicare and Medicaid Services (CMS) a federal agency under DHHS Department of Health and Human Services (DHHS) the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. (also known as HHS) Department of Health and Human Services Homepage that administers the Medicare program, partners with states to administer Medicaid, surveys and certifies health care facilities and regulates all laboratory testing. CMS Homepage policy on what Medicare will pay for during a clinical trial and how this might be accomplished. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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