Glossary, CRG, NHLBI, NIH

After deciding which mechanism is best for you, you will want to begin writing your application. Review applications of colleagues who have had successful review and funding. Creating a well-organized and well-designed research plan is critical to successful peer review. Be specific in describing what you are proposing to do, why this research is important and how you will do it.

There are a number of resources available to you to help you in this process. You will want to begin with the PHS 398 or SF424 form and its instructions. Read the instructions carefully before developing your research plan. The instructions give details about page limitations, format specifications, human subjects

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction

Interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.

or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.

research requirements, and budget. Some types of mechanisms are now using Electronic Submission of 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.

Applications.

Organize your research plan in a logical fashion. NIAID has created a detailed tutorial called NIH Grant Cycle: Application to Renewal that takes you through the process.

Include enough information to show you know what you're talking about. Tell them how your early work prepares you for the new project.

Other Resources:

Grant Writing Tutorial from the National Library of Medicine
Grant Writing Tips from OER
NIH Regional Seminar Presentations: Grant Writing for Success(7 MB)
CSR

Center for Scientific Review (CSR)
the portal for NIH grant applications and their review for scientific merit. It organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH. CSR Homepage

Advice to Investigators Submitting Clinical Research

Clinical Research
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.

Applications

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

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Home » Clinical Research Guide» Application» Where can I get help with writing the 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	Where can I get help with writing the application? After deciding which mechanism is best for you, you will want to begin writing your application. Review applications of colleagues who have had successful review and funding. Creating a well-organized and well-designed research plan is critical to successful peer review. Be specific in describing what you are proposing to do, why this research is important and how you will do it. There are a number of resources available to you to help you in this process. You will want to begin with the PHS 398 or SF424 form and its instructions. Read the instructions carefully before developing your research plan. The instructions give details about page limitations, format specifications, human subjects Human Subject Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction Interaction any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46. or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research requirements, and budget. Some types of mechanisms are now using Electronic Submission of 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. Applications. Organize your research plan in a logical fashion. NIAID has created a detailed tutorial called NIH Grant Cycle: Application to Renewal that takes you through the process. Include enough information to show you know what you're talking about. Tell them how your early work prepares you for the new project. Other Resources: Grant Writing Tutorial from the National Library of Medicine Grant Writing Tips from OER NIH Regional Seminar Presentations: Grant Writing for Success(7 MB) CSR Center for Scientific Review (CSR) the portal for NIH grant applications and their review for scientific merit. It organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH. CSR Homepage Advice to Investigators Submitting Clinical Research Clinical Research patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects. Applications Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Where can I get help with writing the application?