Glossary

Any unexpected health problem that happens during a clinical trial. It may or may not be related to the investigational product being studied or the trial procedures.

Any unexpected health problem that trial doctors believe is possibly related to an investigational product, procedure, or other care given in the trial.

When health authorities, like the FDA or EMA, have reviewed the research and have decided the investigational product is safe and works well enough to be used by the public.

A group in a clinical trial that receives a specific form of care – whether it is the investigational product, standard of care, placebo, or something else.

A trial where participants do not know which research group they are assigned to. This means they do not know the dose or identity of the drug or procedure they are receiving. This helps keep results fair.

A research study that tests how well new drugs, vaccines, devices, or other medical approaches work for people.

A group in a clinical trial that gets the standard of care or a placebo. This helps researchers compare results.

A group of experts who check trial results to make sure it is safe and fair.

When some groups of people are more likely to get certain diseases than others. This can be due to genetics, environment, or other factors. Having people from different backgrounds in clinical trials helps make sure new treatments work for everyone.

A clinical trial where neither participants nor the trial team know who is getting the investigational product and who is getting a placebo or other treatment . This helps make sure results are fair and unbiased.

How well an investigational product works in a clinical trial. It can mean reducing symptoms or improving a condition.

The rules about who can or cannot join a clinical trial. These rules are based on things like age, health, or medical history. This includes both inclusion criteria and exclusion criteria.

A result that researchers measure in a clinical trial to see how an investigational product affects people. This could be fewer symptoms, better control of the disease, or how safe the product is.

You are enrolled in a trial once the trial team confirms you meet the rules, and you agree to take part.

A list of rules that explain who cannot join a clinical trial. For example, someone might be excluded if they are too young or too old, take certain medications, or have other health conditions.

A way for people to get an investigational product outside of a trial, if no other options exist.

A person who does not have the condition being studied. They join trials to help researchers understand the safety of an investigational product and how it works in the body.

A list of rules that explain who can join a clinical trial. This might include being in a certain age range, having the condition being studied, or being able to give permission to take part.

A document that explains the details of a clinical trial in plain language. You must read and sign it before joining, to show that you understand the trial and agree to take part.

A group that reviews and approves clinical trials to help protect participants. It includes doctors, scientists, patient advocates, community members, and others. They make sure the trial is legal, ethical, and has a plan to keep people safe. Every trial must be approved by an IRB or EC before it can begin. There is usually an IRB at every health care facility that does medical research.

A clinical trial where patients receive an investigational product to see if it works and is safe. This could include a drug, medical device, procedure, vaccine, or changes to things like diet or exercise.

A drug, vaccine, medical device, or other medical approach that is being studied in a clinical trial. It has not yet been approved for the condition being studied. Sometimes it's a completely new product, and other times it's already approved for a different condition.

Investigational products may only be available through clinical trials. You may also hear them called "experimental" products.

A person who collects and tests samples, like blood or urine, during a clinical trial.

A clinical trial where doctors track patients' health over time without giving any investigational products.

A trial where both patients and researchers know which investigational product is being given.

A person who enrolls in a clinical trial. The word "participant" is used to show that the person has voluntarily decided to take part in the trial. You may see the word "subject" or "patient" used in place of participant.

A healthcare professional who prepares and gives the medicines and devices used during the trial, including the investigational products. Pharmacists also make sure the products are stored and used safely during the trial.

Clinical trials are usually done in phases (1, 2, 3, or 4) that build on one another. Each phase is designed to answer certain questions. Early phases focus on safety and how an investigational product works. Later phases look at how well the product works and continue to monitor safety.

A product that looks like an investigational product but has no active medicine in it. Some trials use placebos to help researchers see if the investigational product being tested really works.

A Plain Language Summary (PLS) is an easy-to-read summary of the main results from a clinical trial. These summaries share the trial findings, recognize the important role of the people who took part in the trial, and help them learn more about the research they were part of.

A PLS may also be called a Trial Results Summary, a Layperson Summary, or a Lay Summary.

A clinical trial done after an investigational product is approved to check its long-term effects and safety. When referring to medical devices, it may also be called a post-market trial.

A clinical trial done before an investigational product is approved. The term pre-market trial is often used when referring to medical device trials.

The lead doctor or researcher in charge of a clinical trial.

The detailed plan for how a clinical trial will be done. It explains the steps, tests, and what information will be collected to see if the investigational product is safe and if it works.

A method where a computer randomly decides which people in a trial go into different research groups. This helps make sure that everyone has an equal chance of being in any group.

A government group that reviews clinical trial results and decides if an investigational product can be approved for public use.

A nurse who helps with care, visits, and procedures for a clinical trial.

The part of a clinical trial when tests are done to see if a patient is a good fit for the trial.

A doctor with special training who supports a clinical trial when needed (like cardiologists or radiologists).

The group responsible for running the clinical trial. This is usually a pharmaceutical company, university, or non-profit organization. They manage the trial and work closely with the doctors and staff.

The usual treatment that doctors give for a specific condition. Some trials compare an investigational product to the standard of care to see how they work differently.

Another word for a clinical trial. You may see terms like study site, study doctor, study coordinator, or study visits, but they mean the same as trial site, trial doctor, trial coordinator, and trial visits. The words "study" and "trial" are often used interchangeably.

A researcher who helps the lead doctor (principal investigator) run the clinical trial.

Health checks done during a clinical trial to see how you're doing. These may include checking your vital signs, doing physical exams, collecting blood or urine samples, and asking questions about how you feel.

You will be required to attend clinic visits throughout a trial. During each clinic visit, the trial doctor and team will check your health with different tests. The number of visits you need will depend on which trial you join.

A person who helps manage a clinical trial and supports patients. Also known as a study coordinator or clinical research coordinator.

The trial doctor who is in charge of the trial. A trial doctor may also be called a study doctor, a principal investigator (PI), or simply an investigator.

Another name for the investigational product being tested in a clinical trial. It may also be called the study drug, study medicine,or investigational drug.

The hospital, clinic, or doctor's office where a clinical trial takes place. A trial site must go through an approval process to be part of a clinical trial. Trial sites have the expertise and resources to be able to carry out the trial properly.

Participation in a clinical trial is your decision. That means you don't have to participate if you don't want to. Even if you participate, you can leave a trial at any time and for any reason.