Clinical trials can come with a lot of new words.
This glossary turns those terms into simple, friendly explanations so you always know what’s going on — no medical degree required.
Glossary
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Adverse Event (AE)
Something that happens during the study that doesn’t feel normal — like a new ache, tummy trouble, or anything that feels “off.”
If you think, “Hmm, that’s weird,” tell your grown-up or the study team. -
Assent
Assent is a child’s way of saying “Yes, I understand and I want to do this.”
It’s not a legal signature — it’s a respectful check-in to make sure kids understand the study in their own words and feel good about joining. -
Blinding / Double-Blind
A setup where you don’t know which treatment you’re getting — and neither does the study team.
Everyone stays “in the dark” so results stay fair. -
Concomitant Medication
Any medication or supplement you take along with the study drug.
Some are okay. Some aren’t.
Basically: “Tell us everything you take, even the weird vitamins.” -
Dosing Schedule
When and how often you take the study drug.
Morning? Night? With food? No food?
It’s the “when + how” of your treatment. -
Eligibility Criteria
The list of rules about who can join the study and who can’t.
It’s not personal — just part of keeping the study safe and accurate. -
Informed Consent
A conversation, not just a form.
It’s where the study team explains the study, answers your questions, and makes sure you really understand what you're signing up for.
You can always ask more questions — that’s the whole point. -
Investigational Product (IP) / Study Drug
The treatment being tested.
It’s new — that’s why the team watches you closely while you’re on it. -
Placebo
A “pretend” version of the study treatment that looks the same but doesn’t have the active ingredient.
Your body won’t know, but your symptoms might surprise you anyway (that’s normal). -
Principal Investigator (PI)
The doctor in charge of the study at your site.
They’re the lead decision-maker and make sure everything is done safely and correctly. -
Protocol
The study’s big rulebook.
It tells the team: when visits happen, what procedures are done, what the drug dose is, who can join, etc.
Kind of like a recipe — if everyone follows the same steps, the results make sense. -
Randomization
A fancy way of saying “assigned by chance.”
Like flipping a coin to decide which study group you’re in — except a computer does the flipping. -
Screening
Health checks and tests to make sure the study is right for you — and you’re right for the study.
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Study Arm
Just a group in the trial.
Think of it like being on Team A or Team B — same game, different plays. -
Study Coordinator
Your guide through the entire trial — scheduling visits, answering questions, cheering you on.
If the trial were a road trip, the coordinator is your GPS. -
Study Drug / Investigational Product (IP)
The treatment being tested.
It’s new, it’s being studied, and that’s why the team watches you so closely while you're on it. -
Visit Window
The time frame in which you’re supposed to come to a study visit — not always a single day, but more like a “zone.”
If the visit is week 6, the window might be “week 5–7.”
It’s flexible… but not too flexible. -
Washout Period
A break between medicines so your body can take a little rest.