Glossary, CRG, NHLBI, NIH

As described earlier, an activity that requires on-going attention in Clinical Trial

Clinical Trial
A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I

Phase I Clinical Trial
testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).

, Phase II

Phase II Clinical Trial
study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.

, Phase III

Phase III
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.

, Phase III(as defined by NIH)

Phase III(as defined by NIH)
is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.

, Phase IV

Phase IV Clinical Trial
studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.

)

is the recruitment and retention of participants in your study. It is your responsibility 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.

to monitor patient recruitment and retention in the study. 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.

program staff will also monitor enrollment at least annually via your progress report. Some studies will provide enrollment information more regularly but communication between NHLBI and the investigator about patient accrual is encouraged. The policy on Terms and Conditions for Accrual of Research Subjects in Research offers further information on single-or multi-center studies that expect to recruit 150 or more subjects.

The Office of Research on Women's Health provides an Outreach Notebook and Frequently Asked Questions on the topic of recruitment and retention of women and minorities as research subjects with practical applications for conducting NIH-funded research.

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

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Home » Clinical Research Guide » Management » Who should monitor subject recruitment/retention?
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	Who should monitor subject recruitment/retention? As described earlier, an activity that requires on-going attention in Clinical Trial Clinical Trial A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I Phase I Clinical Trial testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects). , Phase II Phase II Clinical Trial study in a larger group of people (several hundred) to determine efficacy and further evaluate safety. , Phase III Phase III study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use. , Phase III(as defined by NIH) Phase III(as defined by NIH) is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials. , Phase IV Phase IV Clinical Trial studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use. ) is the recruitment and retention of participants in your study. It is your responsibility 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. to monitor patient recruitment and retention in the study. 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. program staff will also monitor enrollment at least annually via your progress report. Some studies will provide enrollment information more regularly but communication between NHLBI and the investigator about patient accrual is encouraged. The policy on Terms and Conditions for Accrual of Research Subjects in Research offers further information on single-or multi-center studies that expect to recruit 150 or more subjects. The Office of Research on Women's Health provides an Outreach Notebook and Frequently Asked Questions on the topic of recruitment and retention of women and minorities as research subjects with practical applications for conducting NIH-funded research. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Who should monitor subject recruitment/retention?