Glossary, CRG, NHLBI, NIH

How: 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.

is in the process of converting systems to require Electronic Submission of all grant applications by September 2007. Applicants are encouraged to prepare themselves now to participate in electronic submission. Grants.gov offers step-by-step instructions for electronic submission of applications in Apply for Grants. NIH has training information on Electronic Submission of 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 Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

Applications. You will also find SF424 Application and Electronic Submission Information on the OER

Office of Extramural Research (OER)
a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage

website.

When: In general, most new clinical research grant applications have three receipt dates each year (See Submission Dates/Deadlines). This is unlike applications that are in response to a RFA, RFP

Requests for Proposals (RFP)
initiatives sponsored by an NIH institute for a contract to meet a specific need, such as the development of an animal model or circulatory assist devices or a specific multicenter clinical trial.

or PA

Program Announcements (PA)
NIH announcements requesting grant applications in stated scientific areas where money is generally not set aside to pay for the grants.

where a specific due date is delineated in the announcement.

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

describes in detail the Submission and Assignment Process here.

Remember that applications that exceed $500,000 in direct costs

Direct Costs
costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others.

in any year are subject to additional submission rules and may not simply be submitted to CSR without prior approval of NHLBI. If CSR receives such an application, it will be returned to you without review. (See "What if my project exceeds $500,000 in direct costs")

Multiple Principal Investigators is a new opportunity to formally allow more than one Principal Investigator ( 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.

) on individual research awards particularly on projects that require a team approach. Read the information carefully to acquaint yourself with which mechanisms allow multiple investigators and how to indicate this in your grant application.

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

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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	How and when do I submit my application? How: 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. is in the process of converting systems to require Electronic Submission of all grant applications by September 2007. Applicants are encouraged to prepare themselves now to participate in electronic submission. Grants.gov offers step-by-step instructions for electronic submission of applications in Apply for Grants. NIH has training information on Electronic Submission of 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 Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. Applications. You will also find SF424 Application and Electronic Submission Information on the OER Office of Extramural Research (OER) a NIH office that supports extramural research by providing policy and guidance to the NIH ICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage website. When: In general, most new clinical research grant applications have three receipt dates each year (See Submission Dates/Deadlines). This is unlike applications that are in response to a RFA, RFP Requests for Proposals (RFP) initiatives sponsored by an NIH institute for a contract to meet a specific need, such as the development of an animal model or circulatory assist devices or a specific multicenter clinical trial. or PA Program Announcements (PA) NIH announcements requesting grant applications in stated scientific areas where money is generally not set aside to pay for the grants. where a specific due date is delineated in the announcement. 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 describes in detail the Submission and Assignment Process here. Remember that applications that exceed $500,000 in direct costs Direct Costs costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others. in any year are subject to additional submission rules and may not simply be submitted to CSR without prior approval of NHLBI. If CSR receives such an application, it will be returned to you without review. (See "What if my project exceeds $500,000 in direct costs") Multiple Principal Investigators is a new opportunity to formally allow more than one Principal Investigator ( 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. ) on individual research awards particularly on projects that require a team approach. Read the information carefully to acquaint yourself with which mechanisms allow multiple investigators and how to indicate this in your grant application. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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How and when do I submit my application?