Glossary, CRG, NHLBI, NIH

Application

With the goal of improving public health, 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.

seeks to fund the best scientific research projects that are submitted and within the budget. The peer review system evaluates each project for its merit, the ability of the investigator to accomplish the proposed work and scientific quality. Your project must be unique. By law, NIH cannot support a project already funded or pay for research already done. And you may not send the same application to more than one Public Health Service ( PHS

Public Health Service (PHS)
governmental division comprised of agencies related to health and human services such Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services ( CMS ), Food and Drug Administration (FDA), and National Institutes of Health (NIH) to name a few. DHHS Homepage

) at the same time.

But proposing elegant science is not enough. Reviewers can't read minds and if you don't write the information into your application, it might as well not exist. This section is designed to help you in writing an application and will answer the following questions about preparing and submitting a proposal:

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

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Home » Clinical Research Guide » Application
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	Application With the goal of improving public health, 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. seeks to fund the best scientific research projects that are submitted and within the budget. The peer review system evaluates each project for its merit, the ability of the investigator to accomplish the proposed work and scientific quality. Your project must be unique. By law, NIH cannot support a project already funded or pay for research already done. And you may not send the same application to more than one Public Health Service ( PHS Public Health Service (PHS) governmental division comprised of agencies related to health and human services such Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services ( CMS ), Food and Drug Administration (FDA), and National Institutes of Health (NIH) to name a few. DHHS Homepage ) at the same time. But proposing elegant science is not enough. Reviewers can't read minds and if you don't write the information into your application, it might as well not exist. This section is designed to help you in writing an application and will answer the following questions about preparing and submitting a proposal: How can I find funding opportunities? 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 Section E: Human Subjects Research? How do I submit my application? Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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