Glossary, CRG, NHLBI, NIH

Who will review my application and when?

Your clinical 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.

Application ( GA

Grant Application
An application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper 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

398 or electronic SF 424 forms and instructions.

) is assigned for review to either CSR

Center for Scientific Review (CSR)
the portal for NIH grant applications and their review for scientific merit. It organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH. CSR Homepage

or to an 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.

Review group. CSR reviews most R01s, R21s, pre and postdoctoral fellowships, and small business applications. In 2005, the number of grants submitted to NIH grew to 73,000 with 52,000 of these being reviewed by CSR. NHLBI review groups handle applications that have Institute-specific features such as program projects, training grants, career development awards, responses to Requests for Applications and some clinical studies.

The Peer Review Process is an excellent CSR overview of the process for assignment and review of your application. A short video called Inside the Grant Process (39 minutes) will help give you a glimpse into a study section meeting and the peer review process at NIH. CSR presents Descriptions of the Integrated Review Groups, Study Sections and Small Business Activities to give applicants a better understanding of the organization and function of the review groups.

Multi-center clinical applications are assigned to an NHLBI review group, the Clinical Trials Review Committee (CLTR). CLTR is a standing committee composed of experts in heart, lung and blood diseases with biostatisticians and ad hoc reviewers. The review criteria and process is similar to CSR with the standard scoring system. CLTR meets three times a year in February, June and October in which new AND amended applications are reviewed.

Your application will be reviewed approximately 4 months after the receipt date.

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

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Home » Clinical Research Guide » Review » Who will review my application and when?
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	Who will review my application and when? Who will review my application and when? Your clinical 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. Application ( GA Grant Application An application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper 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 398 or electronic SF 424 forms and instructions. ) is assigned for review to either CSR Center for Scientific Review (CSR) the portal for NIH grant applications and their review for scientific merit. It organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH. CSR Homepage or to an 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. Review group. CSR reviews most R01s, R21s, pre and postdoctoral fellowships, and small business applications. In 2005, the number of grants submitted to NIH grew to 73,000 with 52,000 of these being reviewed by CSR. NHLBI review groups handle applications that have Institute-specific features such as program projects, training grants, career development awards, responses to Requests for Applications and some clinical studies. The Peer Review Process is an excellent CSR overview of the process for assignment and review of your application. A short video called Inside the Grant Process (39 minutes) will help give you a glimpse into a study section meeting and the peer review process at NIH. CSR presents Descriptions of the Integrated Review Groups, Study Sections and Small Business Activities to give applicants a better understanding of the organization and function of the review groups. Multi-center clinical applications are assigned to an NHLBI review group, the Clinical Trials Review Committee (CLTR). CLTR is a standing committee composed of experts in heart, lung and blood diseases with biostatisticians and ad hoc reviewers. The review criteria and process is similar to CSR with the standard scoring system. CLTR meets three times a year in February, June and October in which new AND amended applications are reviewed. Your application will be reviewed approximately 4 months after the receipt date. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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