Glossary, CRG, NHLBI, NIH

Observational Study:
A biomedical or behavioral research study of 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.

designed to assess risk factors for disease development or progression, assess natural history of risk factors or disease, identify variations based on geographic or personal characteristics (such as race/ethnicity or gender), track temporal trends, or describe patterns of clinical care and treatment in absence of specific study-mandated interventions.

Interventional Study:
For purposes of reviewing 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 and contract

Contract
award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition

Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy)

Management and Policy (OAMP) web site provides additional information

proposals submitted to the NIH, a clinical trial is operationally defined as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices) or behavioral interventions.
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. Clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:

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.
(see also NIH-Defined Phase III 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 II , Phase III , 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.
)
)
Phase IV

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

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Home » Clinical Research Guide» Application» Is my study observational or interventional?
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	Is my study observational or interventional? Observational Study: A biomedical or behavioral research study of 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. designed to assess risk factors for disease development or progression, assess natural history of risk factors or disease, identify variations based on geographic or personal characteristics (such as race/ethnicity or gender), track temporal trends, or describe patterns of clinical care and treatment in absence of specific study-mandated interventions. Interventional Study: For purposes of reviewing 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 and contract Contract award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition Office of Acquisition (OA) OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy) Management and Policy (OAMP) web site provides additional information proposals submitted to the NIH, a clinical trial is operationally defined as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices) or behavioral interventions. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. Clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases: 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. (see also NIH-Defined Phase III 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 II , Phase III , 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. ) ) Phase IV Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Is my study observational or interventional?