Glossary, CRG, NHLBI, NIH

How do I register my study?

Every study funded by 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.

should be registered in the National Library of Medicineâ€™s Clinical Trials Protocol Registration System (PRS) in order to enter clinical trial records into ClinicalTrials.gov. ClinicalTrials.gov provides patients, family members, and members of the public current information about clinical research studies. More detailed information about the ClinicalTrials.gov registration process for NHLBI studies can be accessed in the Protocol Registration System. Questions about who should register and the process can be sent to NHLBI staff at register@clinicaltrials.gov

If you want your study to be considered for publication in a journal governed by the International Committee of Medical Journal Editors (ICMJE), make sure you understand its registration policy. Depending on the type of trial you're conducting, ICMJE's publication policy may require that you register your trial before you enroll your first patient. The ICMJE

International Committee of Medical Journal Editors (ICMJE)
Initially known as the "Vancouver Group," this group first met in 1978 to establish formatting guidelines (known as the Uniform Requirements for Manuscripts) for manuscripts submitted to their journals. As it began to respond to issues beyond the scope of manuscript preparation, the group expanded and became more formalized and is now known as the International Committee of Medical Journal Editors (ICMJE).

has more information at their web page, "Obligation to Register Clinical Trials".

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

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Home » Clinical Research Guide» Funding» How do I register my study?
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	How do I register my study? Every study funded by 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. should be registered in the National Library of Medicineâ€™s Clinical Trials Protocol Registration System (PRS) in order to enter clinical trial records into ClinicalTrials.gov. ClinicalTrials.gov provides patients, family members, and members of the public current information about clinical research studies. More detailed information about the ClinicalTrials.gov registration process for NHLBI studies can be accessed in the Protocol Registration System. Questions about who should register and the process can be sent to NHLBI staff at register@clinicaltrials.gov If you want your study to be considered for publication in a journal governed by the International Committee of Medical Journal Editors (ICMJE), make sure you understand its registration policy. Depending on the type of trial you're conducting, ICMJE's publication policy may require that you register your trial before you enroll your first patient. The ICMJE International Committee of Medical Journal Editors (ICMJE) Initially known as the "Vancouver Group," this group first met in 1978 to establish formatting guidelines (known as the Uniform Requirements for Manuscripts) for manuscripts submitted to their journals. As it began to respond to issues beyond the scope of manuscript preparation, the group expanded and became more formalized and is now known as the International Committee of Medical Journal Editors (ICMJE). has more information at their web page, "Obligation to Register Clinical Trials". Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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