Glossary, CRG, NHLBI, NIH

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

My study involves foreign grants and contracts.

NHLBI Policy on Foreign Grants mirrors 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.

policy. The Fogarty International Center ( FIC ) is the international component of the NIH. FIC is involved in the foreign clearance process for grants from a foreign institution or for domestic grants that will utilize foreign sites for the conduct of the research. The process for obtaining foreign clearance can take a considerable amount of time. It is recommended that you begin discussions with your Program Official (PO)

Program Official (PO)
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer

Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ).

if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director.

early in the process if your 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.

or contract has an international component.

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

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Home » Clinical Research Guide» Funding» My study involves foreign grants and contracts
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	My study involves foreign grants and contracts. NHLBI Policy on Foreign Grants mirrors 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. policy. The Fogarty International Center ( FIC ) is the international component of the NIH. FIC is involved in the foreign clearance process for grants from a foreign institution or for domestic grants that will utilize foreign sites for the conduct of the research. The process for obtaining foreign clearance can take a considerable amount of time. It is recommended that you begin discussions with your Program Official (PO) Program Official (PO) staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer Project Officer the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director. early in the process if your 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. or contract has an international component. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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