Glossary, CRG, NHLBI, NIH

What do I need to know before submitting a clinical research application?

Information in the remainder of this section should help to answer many of your questions about submitting a clinical research application. 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.

staff are available to speak with you about your ideas or to guide you through policies or processes that may be confusing. Feel free to contact any staff member. This is not an imposition – it is part of our mission to help facilitate research of all kinds. If the person that you originally contacted cannot help you, he or she will connect you with someone who can. (See “Which NHLBI staff can help me?")

In general, it takes sufficient time and organization to write a 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.

application. Writing can take 3-6 months depending on many factors. From the time it is received at NIH, it can take approximately 9 more months until you get funded. NIAID has prepared a Timeline to help you in your preparations.

Information on general grants issues and clinical research can be found on various NIH and NHLBI websites. Here are a few to help you get started:

The NIH Office of Extramural Research ( 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

) provides information on funding opportunities, grants policy, forms and deadlines. The OER Human Subjects Web Site: FAQs from Applicants is another good source of information.

NHLBI provides additional information on Funding, Training and Policies that may be applicable to NHLBI-funded research.

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

Skip to content past banner and navigation links U.S. Department of Health & Human Services National Institutes of Health Contact Us Get Email Alerts Font Size Accessible Search Form Advanced Search Search the NHLBI, use radio buttons below to select whole site or Disease and Conditions Index only NHLBI Entire Site NHLBI Entire Site1 Diseases & Conditions2
Home » Clinical Research Guide» Application» What do I need to know before submitting a clinical research 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	What do I need to know before submitting a clinical research application? Information in the remainder of this section should help to answer many of your questions about submitting a clinical research application. 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. staff are available to speak with you about your ideas or to guide you through policies or processes that may be confusing. Feel free to contact any staff member. This is not an imposition – it is part of our mission to help facilitate research of all kinds. If the person that you originally contacted cannot help you, he or she will connect you with someone who can. (See “Which NHLBI staff can help me?") In general, it takes sufficient time and organization to write a 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. application. Writing can take 3-6 months depending on many factors. From the time it is received at NIH, it can take approximately 9 more months until you get funded. NIAID has prepared a Timeline to help you in your preparations. Information on general grants issues and clinical research can be found on various NIH and NHLBI websites. Here are a few to help you get started: The NIH Office of Extramural Research ( 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 ) provides information on funding opportunities, grants policy, forms and deadlines. The OER Human Subjects Web Site: FAQs from Applicants is another good source of information. NHLBI provides additional information on Funding, Training and Policies that may be applicable to NHLBI-funded research. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
Twitter Facebook YouTube SEARCH \| ACCESSIBILITY \| READERS & PLAYERS \| SITE INDEX \| OTHER SITES \| PRIVACY STATEMENT \| FOIA \| CONTACT US \| OIG National Institutes of Health Department of Health and Human Services USA.gov