Glossary

Follow-up:

Part of a clinical trial that happens after you finish treatment. It includes regular check-ins with the study team—like visits, phone calls, or tests—to see how you are doing, watch for side effects, and track how well the treatment may work over time.

Good Clinical Practice:

A set of rules and standards that make sure clinical trials are done properly and with respect for participants.

Indication:

The disease(s) or medical condition(s) that a treatment is meant to be used for (eg, a cancer drug may have an indication for breast cancer).

Informed consent:

Process of learning about a clinical trial before deciding whether to participate. You will get clear information about the purpose of the study, the treatments involved, possible risks and benefits, and your rights as a participant. It will also explain what will happen during the study, so you know what to expect if you choose to participate. You will only sign the consent form if you understand the details and agree to take part—participating is always voluntary.

Institutional Review Board:

A group of experts who review and approve clinical trials to make sure they are safe and ethical for participants.

Interventional trial:

Study where participants receive specific treatments or follow certain procedures that doctors are testing to see how they affect their health.

Non-interventional study:

Study where researchers observe patients and collect information without giving them a specific treatment or making changes to their care.

Open-label:

Everyone in the study—both doctors and participants—knows which treatment is being given.

Personal health information:

Details about your health and medical care, like your name, date of birth, medical history, test results, and treatments you have received.

Placebo:

This is an inactive treatment. It is usually a substance that looks like the treatment being tested but does not contain any active ingredients. It helps researchers determine whether the real treatment may work.

Plain language summary:

An easy-to-read version of clinical trial results written for people without medical or scientific training.

Protocol:

The official plan for how the clinical trial will be done. It explains information such as the purpose of the study, who can take part, what treatments will be given, how often visits or tests will happen, and what information will be collected. All doctors in a specific clinical trial follow the same protocol to keep the study consistent.

Randomized clinical trial:

A study where participants are randomly (by chance) assigned to different treatment groups, so the results are fair and not biased.

Regulatory approval:

Official permission from a government health agency (like the FDA) to allow a treatment to be used in the general public.

Screening:

The step before officially participating in a clinical trial. During screening, the study team will do tests, ask questions, and review your medical history to see if you meet the eligibility criteria. This helps make sure that you are a good fit for the study.

Side effect:

Unwanted or unexpected symptom that can happen during or after receiving treatment. It can be mild, like feeling tired or having a headache, or more serious, depending on the treatment. In a clinical trial, all side effects are carefully watched and recorded to help keep you safe.

Single-blind:

Only the participant does not know which treatment they are getting; the doctors know.

Standard treatment (also called standard of care):

The most common or widely used treatment for a specific disease, like a type of cancer. In some clinical trials, a new treatment is often compared to the standard treatment to see which one works better or has fewer side effects.

Statistical analysis plan:

A detailed plan explaining how the data from a clinical trial will be studied and what kinds of statistics will be used to understand the results.

Study coordinator:

A person who helps organize the clinical trial, supports participants, and makes sure the study follows the protocol.

Study drug:

The investigational medicine(s) or investigational treatment(s) being tested in a clinical trial. It may be a drug that is not approved yet or a drug that is already used for other diseases but is now being tested in a new way or for a different disease/condition. The study drug is given to see how safe it is and how well it works.

Treatment plan:

A detailed summary of the care you will receive during a clinical trial. It includes information like the type of treatment, how and when it will be given (such as pills, intravenous infusion, or shots), how long the treatment will last, and what tests or checkups will be done along the way. Your treatment plan helps guide your care.