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About clinical trials

Glossary of trial terms

The words you will meet on a consent form, each explained in a sentence or two.

An open dictionary page in close-up

Research has its own vocabulary. These are the words you are most likely to meet on a consent form or in a call with a study team.

Adverse event
Any unwanted change in your health during a study, whether or not the study treatment caused it. Teams record every one.
Arm
One group within a study. Each arm receives a different treatment, dose or schedule.
Blinding
Keeping people from knowing which treatment each volunteer receives, so that expectations cannot colour the results. In a double-blind study, neither you nor the team knows.
Control group
The volunteers who receive a placebo or a standard treatment, so the new one has something to be measured against.
Eligibility criteria
The rules about who a study can include. Inclusion criteria say who can join; exclusion criteria say who cannot, usually for safety.
Informed consent
The process of having a study explained to you, asking questions and then deciding whether to agree. It ends with a signed form but continues for as long as you take part.
Institutional review board (IRB)
An independent committee that must approve a study before it starts and keeps watch over it, to protect the people who take part.
Investigator
The doctor or scientist who leads a study at a site. The principal investigator is responsible for everything that happens there.
Observational study
A study that watches and measures without giving any treatment, for example following people’s health over several years.
Phase
The stage a medicine has reached in testing, from small early studies of safety to large studies that compare it with existing care.
Placebo
Something made to look like the study treatment but with no active ingredient in it.
Protocol
The written plan for a study: who can join, what happens at each visit and how the results will be measured.
Randomisation
Assigning volunteers to arms by chance, like a coin toss, so the groups are alike at the start.
Screening
The first visit or call, where the team checks whether you meet the eligibility criteria.
Site
The clinic, hospital or research unit where your study visits happen.
Sponsor
The company, university or government body that pays for a study and is responsible for it overall.
Study coordinator
The person at the site who arranges your visits and is usually your first contact with questions.
Washout
A period before a study starts when you stop a medicine, so that it does not affect the results. Only ever done with the team’s guidance.

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