Glossary of Research Terms

A     B     C     D     E     F     G     H     I     J     K     L     M     N     O     P     Q     R     S     T     U     V     W     X     Y     Z

B

Blinded study

One or more of the groups involved in the trial (participant or study team) have no knowledge of what treatments have been assigned to particular participants. This is done to reduce bias. If medically necessary, however, it is always possible to find out which treatment you are receiving.

C

Clinical study/trial

Research which uses human volunteers (participants) and are aimed at evaluating a medical, surgical or behavioral intervention. The most effective way for researchers and medical professionals to find out if an investigational treatment or medication is safe and effective to use.

ClinicalTrials.gov ID (NCT number)

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Longitudinal and observational studies may not have this ID.

E

Eligibility criteria

The requirements that participants must meet before taking part in a study. It includes both inclusion criteria and exclusion criteria that are defined in the protocol.

I

Informed consent

When permission to take part in a clinical study is granted by a participant who has full knowledge of the possible risks and benefits they might face.

Infusion

A way to give a fluid, usually the investigational drug, to the study participant, usually through a vein.

Intervention

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices,

procedures, and other treatments that are either investigational or already available.

Investigational drug/study drug

The experimental drug which is being evaluated in the clinical trial; and is not approved by the United States Food and Drug Administration (FDA) to treat the disease being studied.

L

Longitudinal study

Research that collects data from the same participants over a long time. These studies may collect information from participants’ medical charts, study questionnaires, and blood or other samples.

O

Observational study

A study that collects health information about study participants and does not include an investigational drug or treatment. Participants are observed and their health outcomes are measured by the study investigators.

Open-label

A type of study where participants and research staff know which treatment participants are being given. Open-label means that there is no placebo.

P

Placebo

A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, investigational treatments are often compared with placebos to assess the treatment's effectiveness.

Protocol

The written description of a clinical study. It includes the study's objectives, design, and methods.

R

Randomization

A strategy in which participants are randomly assigned to receive the intervention or placebo.

It is used to reduce bias.

S

Standard of care

The usual treatment given to patients for a disease or health problem.

Subcutaneous injection

A subcutaneous (SQ) injection is given into the fatty tissue just beneath the skin, which is the layer between the skin and the muscle