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Research Vocabulary and Links

Research Vocabulary:

Clinical study: A research study using human participants to evaluate the effect of interventions (i.e. new medications, treatments or health screening) or exposures (i.e. travel, food consumed from a particular restaurant on a particular day or even a specific type of military service) on health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies.

Clinical Trial (or Interventional Study): A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on health-related outcomes. The assignments are determined by the study regulations. Participants may receive diagnostic, therapeutic, or other types of interventions.

Cohort: Individuals who share a common characteristic or experience within a defined time frame (e.g.,
age, gender or have certain diseases or symptoms).

Double Blind Masking: A type of masking in which two or more parties involved with the clinical trial do not know which participants have been assigned which interventions (or placebo). Typically, this includes the investigator and participant.

Evidence-based Practice: The incorporation of clinical expertise, patient values, and the best available research into the decision making process for patient care.

Food and Drug Administration (FDA): The FDA is an agency within the Department of Health and Human Services. The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.

Intervention: A process or action that is the focus of a clinical study. This can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches such as surveys, education, and interviews.

Investigator: A researcher involved in a clinical study. Related terms include Site principal investigator, Site sub-investigator, Study chair, Study director, and Study principal investigator.

Investigational New Drug: A drug, or biological product that is used in a clinical trial but has not been approved by the FDA (the drug is either not available for a doctor to prescribe or, is available, but not approved by the FDA for the use being studied).

Masking (or Blinding): A clinical trial design strategy in which one or more parties involved with the trial, such as the investigator or participant, do not know which participants have been assigned which interventions. Types of masking include none Open label, Single blind masking, and Double blind masking.

Parallel Design: Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group receiving drug B.

Placebo: A substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied.

Randomized Clinical Trial: clinical research in which subjects are randomly assigned to treatment and control groups

 

VHA Research and Development Links:

• VA research and the importance of studies
http://www.research.va.gov/for_veterans/#.UciPVj75lF8
• Safeguarding Veterans’ Information
http://www.research.va.gov/for_veterans/safeguarding_vets.cfm#.UciPvT75lF8
• Review active CSP studies
http://www.research.va.gov/programs/csp/studies.cfm#.UciQAz75lF8