Definitions


Behavioral Study

A clinical research study that finds ways to improve quality of life for those with long-lasting diseases.

Biobanking

When researchers store someone’s samples for a study. People donate samples like blood, saliva, urine, skin, or other cells. Researchers store these samples in a secure place.

Clinical Research

The study of health and disease in humans. We need to do research to improve health care. This includes screening, preventing, and treating disease.

Clinical Trial

A study that tests the effects of medical treatments and procedures. Researchers need people to volunteer so we can improve health care.

Consent Form

You will sign a consent form if you agree to take part in a study. Your signature on this form shows that you understand your rights and your role in the study. Researchers will give you all the information you need before you choose to sign a consent form.

Control Group

A group of people in a study who receive standard of care (the typical treatment). They do not receive the trial treatment. Researchers compare the control group to the treatment group. This helps them learn about the trial treatment’s effects.

Diagnostic Study

A clinical research study that tests better ways to identify a disease.

Double-Blind Study

When a study’s medical staff do not know which treatment they are giving. The participant also does not know which treatment they are receiving.

Epidemiological Study

A clinical research study that looks for patterns and causes of disease in groups of people.

Genetic Study

A clinical research study that looks at how genes and illness may be related.

Healthy Volunteer

A person with no known health problems who chooses to take part in research.

Informed Consent

An educational process between you and a study team. You go through this process before you decide if you want to take part in the study. In this process, researchers give you information about the study’s risks and benefits. Researchers also explain your rights as a participant. You can ask any questions you may have. You then sign a consent form if you agree to the study. Your signature shows that you understand your rights and role in the study.

Institutional Review Board (IRB)

A group that reviews & approves a study’s research plans. Each research site has an IRB to enforce all federal laws and ethics guidelines. The IRB must include at least one person without a science background.

Phase I Trial (Phase 1)

Researchers test a new drug or treatment in a small group of people. They learn more about its safety, side effects, and dosage.

Phase II Trial (Phase 2)

Researchers test a drug or treatment with a larger group of people. They learn more about its safety and if it works.

Phase III Trial (Phase 3)

Researchers test a drug or treatment with a large group of people. They check that it works and track any problems. They compare it to usual treatments.

Phase IV Trial (Phase 4)

A study researchers do after a drug or treatment gets approved. Researchers collect data on its effects in different groups. They also collect data about problems with long term use.

Placebo

A harmless pill, liquid, or powder that has no effects. Placebos help researchers figure out if a new treatment works. Researchers compare people receiving a placebo to people receiving a trial treatment. The people who receive the placebo are usually in a control group.

Prevention Study

A clinical research study that looks for a way to prevent a disease.

Principal Investigator (PI)

A scientist who leads the research team. They keep track of the study participants’ health. They make sure the study is safe and effective.

Quality of Life

How good or bad a person’s life is.

Randomization

When a study places participants into different groups by chance. You don’t get to pick which group you will be in. Researchers don’t get to pick your group either. A computer places you into a group at random. It’s like flipping a coin to get heads or tails.

Samples

Materials from your body. Samples might include saliva, hair, urine, blood, skin, or other cells and tissue. They can be collected by biopsy, blood draw, cheek swab, or urine sample.

Screening Study

A clinical research study that tests a way to detect a certain health problem.

Single-Blind Study

When a participant in a study doesn’t know which treatment they are receiving.

Standard of Care

Usual or routine health care. The kind of care that most doctors agree that everyone should receive. Also called: best practice, standard medical care, and standard therapy.

Treatment Group

A group of people in a study who receive the trial treatment. Researchers measure the effects of new treatments from this group. Researchers compare this group to a control group in the study.

Treatment Plan

A specific plan for treating a disease specific to one person.

Treatment Trial

A clinical research study that tests a treatment for a disease.