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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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