Glossary, CRG, NHLBI, NIH

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 » Overview
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	Overview Clinical research has a long history, with much of the early experience resulting from observations before and after a change in treatment. James Lind (1716-1794) is acknowledged as the first person to conduct a clinical trial. Lind, a pioneer of naval hygiene in the Royal Navy, developed the theory that citrus fruits cured scurvy. He argued for the health benefits of better ventilation aboard naval ships, including improved clothing and cleanliness of sailors and below-deck fumigation with sulphur and arsenic. He also proposed that fresh water could be obtained by distilling seawater. Lind influenced practices of preventive medicine and good nutrition among Scottish soldiers. Here you will find answers to the following questions: What is clinical research? What is the role of 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. 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. in clinical research? What are the Project Officer’s responsibilities in clinical research? What is the role of the Principle Investigator/Institution in clinical 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