Glossary, CRG, NHLBI, NIH

Managing a clinical research 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.

involves much more than just enrolling patients into a study. There are many activities that you, as the 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.

, are responsible to do. You are expected to submit on-going reports (to your IRB

Institutional Review Board (IRB)
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).

and 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.

), monitor subjects and study progress, budget and key personnel and communicate with many parties related to your project. This section will help you to better understand which activities are involved in managing your clinical research grant and will answer the following questions:

How do I comply with Good Clinical Practices ( GCP
Good Clinical Practice (GCP)
ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects. The International Conference on Harmonization has developed Guidelines for Good Clinical Practices. See also Good Clinical Practice in FDA-Regulated Clinical Trials.
)
How do I manage my grant?
How do I report amendments, suspensions and terminations?
Must I obtain continuing review from the IRB?
Who should monitor patient 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?
What is HIPAA
Health Insurance Portability and Accountability Act (HIPAA)
a Law to improve portability of health insurance coverage, promote medical savings accounts, improve access to long-term care services and coverage, and simplify administration of health insurance. Implications for research can be found at: Clinical Research and the HIPAA Privacy Rule.
and how do I abide by the requirements?

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

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Home » Clinical Research Guide» Management
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	Management Managing a clinical research 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. involves much more than just enrolling patients into a study. There are many activities that you, as the 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. , are responsible to do. You are expected to submit on-going reports (to your IRB Institutional Review Board (IRB) a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC). and 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. ), monitor subjects and study progress, budget and key personnel and communicate with many parties related to your project. This section will help you to better understand which activities are involved in managing your clinical research grant and will answer the following questions: How do I comply with Good Clinical Practices ( GCP Good Clinical Practice (GCP) ethical and scientific standards for designing, conducting, recording and reporting trials in human subjects. The International Conference on Harmonization has developed Guidelines for Good Clinical Practices. See also Good Clinical Practice in FDA-Regulated Clinical Trials. ) How do I manage my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor patient 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? What is HIPAA Health Insurance Portability and Accountability Act (HIPAA) a Law to improve portability of health insurance coverage, promote medical savings accounts, improve access to long-term care services and coverage, and simplify administration of health insurance. Implications for research can be found at: Clinical Research and the HIPAA Privacy Rule. and how do I abide by the requirements? Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Management