Glossary, CRG, NHLBI, NIH

When your proposal

Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out.

is funded by NHLBI, you agree to be bound by the terms and conditions outlined in the Notice of Grant Award. They take effect as soon as 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.

funds are drawn down. It's important that you pay careful attention to the terms and conditions of your award

Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.

before you begin the project period as changes may have occurred from what you had initially proposed. These changes can occur in your budget, specific aims or in the duration of your award.

In some instances we might place a restriction on your award, restricting it from a particular activity, such as human subjects testing, until paperwork is received and processed. This section will help you to define which activities must be completed before you can begin your clinical study and will answer these questions:

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?

Do I need IRB, IEC or REB approval?

Are there ethical concerns and conflicts of interest I must consider?

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?

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

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Home » Clinical Research Guide» Funding
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	Funding When your proposal Proposal a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out. is funded by NHLBI, you agree to be bound by the terms and conditions outlined in the Notice of Grant Award. They take effect as soon as 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. funds are drawn down. It's important that you pay careful attention to the terms and conditions of your award Award provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity. before you begin the project period as changes may have occurred from what you had initially proposed. These changes can occur in your budget, specific aims or in the duration of your award. In some instances we might place a restriction on your award, restricting it from a particular activity, such as human subjects testing, until paperwork is received and processed. This section will help you to define which activities must be completed before you can begin your clinical study and will answer these questions: How do I know if I am funded? Who needs human subject 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? Do I need IRB, IEC or REB approval? Are there ethical concerns and conflicts of interest I must consider? 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? Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Funding