Clinical Research Glossary - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

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additive effect
The combined effect when two or more things are used together.
adherence
Following the study directions and requirements.
adverse event
Any health problem that happens during the study.
adverse reaction
A health problem that happens during the study and is reported as possibly caused by the study treatment.
analyze
To examine study data to answer a question and help reach conclusions.
anonymize
Remove, change, or hide personal details to protect participant privacy.
antigen
A substance that causes the body's immune system to react.
arm
A group of participants in a research study who all receive the same study treatment.
assent
Willingness to take part in a research study by someone who is not able to give legal consent.
assent form
A document used to explain the details of a research study to children or people who are unable to give legal consent.
assessment
Information that is collected and analyzed from a study participant.

baseline assessment
Information that is collected and analyzed from a study participant at the start of a study.
basket trial
A research study that tests one study treatment for different diseases and conditions.
benefits of a research study
The ways a research study might help the participant and others.
bias (research)
Flaws in the way a study is designed, done, or analyzed that lead to one conclusion being favored over another.
biomarker
Something in the body that is measured as an indicator of personal health or disease.
birth control
A way to prevent pregnancy.
blood draw
Taking a sample of blood by using a needle.

clinical benefit
A health change that researchers measure to show that the study treatment helps the study participants.
clinical research
A controlled method of studying health and illness in people.
Clinical Research Coordinator (CRC)
A research staff member who helps manage studies.
clinical trial
A research study that tests drugs, devices and treatments to see if they are safe and work in people.
clinician
A health care provider.
cohort
A group of study participants that are similar in some way.
Comparative Effectiveness Research (CER)
A study comparing two or more treatments.
compliance
Following research requirements.
Computerized Tomography (CT) scan
A way to take pictures of the inside of a person's body using a type of radiation and a computer.
conduct
To do a study or procedure.
confidence interval
The defined range of numbers used to describe where the results are expected to fall.
confidentiality
Protecting personal information from people who should not have access.
confounding
When the study outcome is influenced by outside conditions that were not expected by the study researchers.
consent form
A document used to explain the planned research before a person decides whether or not to join a study.
Contract Research Organization (CRO)
A group that is paid by the study sponsor to support research studies.
contraindicated
When things should not be used or done together because of possible harm.
control group
The people in a study who do not receive the study treatment or do not have the condition being studied.
correlation
When two or more measures are linked.

data
Information collected from or about people taking part in a research study
Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB)
An independent group of experts that reviews study data to make sure that patient safety is protected.
discontinue (participant)
To remove a study participant from a study.
discontinue (study treatment)
To stop a study treatment in a participant.
disease progression
An illness getting worse over time.
disease-free survival
The length of time after treatment that a person lives without the illness coming back.
dissent
Refusing to be part of a research study.
dose escalation study
A kind of study where increasing amounts of a study treatment are given to different groups to find the best dose.
double-blind study
A study that is set up so that the study treatment that each participant receives is not known by the participants or the researchers.

e-consent (form)
An electronic version of an informed consent form.
effectiveness
How well a treatment works.
efficacy
How well a study treatment works in the study.
eligibility criteria
The reasons a person can be included in, or excluded from, a study.
Emergency Use Authorization (EUA)
A process to make a treatment or vaccine available during a public health emergency, before all research is complete, and before full approval is granted.
endpoint
A measure of the expected effect of the study treatment.
enroll
The action of a participant joining the study after providing informed consent.
epidemiologist
A person who studies where, why, how often, and to what populations health concerns and diseases happen.
equivalence
When two or more things in a study are about the same.
equivalent (effect)
The same or almost the same result.
evaluate
To examine, review, and understand.
exclusion criteria
A list of reasons a person cannot be included in a study.
expanded access
A process for a doctor to request an unapproved treatment for a seriously ill patient.
experimental
Something that is being tested in research but not yet proven.
exploratory research
A process to find facts that can guide the design of future studies.

frequency
How often something happens over a period of time.

generalizability
How research results can apply to people who were not part of the study.

hazard ratio
A measure of risk that compares two treatments in the same study.
healthy volunteer
A study participant who does not have a disease or condition, including the one being studied.
hereditary
A parent's features and traits being passed to their biological children before birth.
hypothesis
An idea that is tested in a research study.

incentive
Something that supports or encourages research participation.
incidence
Number of new cases or events during a period of time.
inclusion criteria
A list of requirements a person must meet to take part in a study.
informed consent
The process of learning and discussing the details of a research study before deciding whether to take part.
infusion
A way to give a fluid to the study participant, usually through a vein.
Institutional Review Board (IRB)
A team of people who review studies to protect the rights and welfare of study participants.
intermittent
Not regular or predictable.
investigational medicine
A treatment or drug that is not yet approved for the condition being studied.
investigational product
A drug, device, vaccine, or other treatment being tested in a study.
investigator
A person who leads a research study.

longitudinal study
Research that collects data from the same participants over a long time.

Magnetic Resonance Imaging (MRI)
A way to take pictures of the inside of a person’s body with a machine that uses strong magnets and radio waves.
maximum
The most or largest amount.
mean
The average.
median
The middle number in a set of numbers when listed in order from lowest to highest.
minimal
Very small.
minimum
The smallest or least amount.
monitor
To observe, check, or evaluate something in a study over time.
morbidity (rate)
The number of people who develop a disease or illness in a group over time.
mortality (rate)
The number of deaths in a group of people over time.
multicenter trial
A study that takes place at more than one research center.

negative test result
A test result that shows a person does not have what was tested for.
negligible
So small that it has little to no impact.
non-compliance
Not following research requirements.
non-inferiority trial
A study to test if a study treatment works about as well as another treatment for the same condition.

objective
A purpose or goal of a study.
observational study
A study that collects health information about study participants without giving a treatment.
observe
To watch or see how participants are doing in a study.
occasionally
Once in a while.
odds ratio
The chance of a health event happening in one group compared with the chance of the same event happening in another group.
off-label
The use of a treatment in a different way or for a condition other than what it is approved for.
open-label
A type of study where participants and research staff know which treatment participants are being given.
outcome (of study)
A description of the overall results of the study.
outcome measure
The way that a study endpoint is measured.

p-value (probability value)
A number that researchers use to show that a result did not occur by chance.
participate
To take part in a study.
Patient Reported Outcomes (PROs)
The information that patients share about their own health or well-being to answer questions in a study.
peer review
Evaluation by independent experts.
periodically
At regular or expected times.
Pharmacodynamic (PD) study
A study that measures the effects of a drug on the human body.
Pharmacokinetic (PK) study
A study that measures what happens to a drug in a person’s body over time.
pharmacovigilance
A process to detect, review, and make decisions about drug safety to protect patients.
phase
A step in the overall clinical research process to test a new drug, device, or treatment.
placebo
Something that looks like the treatment being studied, but doesn't contain any medicine
placebo-controlled study
A study with two or more groups where one group is given a placebo.
platform trial
A research study that tests and compares two or more study treatments for a disease or condition, with study treatment groups being added or removed during the study period.
positive test result
A test result that shows a person has what was tested for.
post-trial access
When participants can still receive a study treatment after their participation has ended.
preclinical study
A study to test a treatment in the lab or in animals before testing it in people.
prevalence
Number of known cases or events in a group.
primary endpoint
A study measure that is used to answer the main research question.
probability
The likelihood or chance that something might happen.
progression-free survival
The length of time without a person's illness getting worse.
prospective study
Research that uses new data collected from participants.
protocol
A complete description of the research plan and procedures.
proxy
A person who is legally allowed to make research decisions for someone else.
pseudonymize
Replace personal details with a code so that data are protected.
purpose
What the study is testing.

Quality of Life (QOL)
How someone feels and functions day to day.
questionnaire
A list of questions for study participants to answer as part of the study.

randomization
A way to use chance to place study participants into different study treatment groups.
randomized controlled trial
Research that uses chance to assign participants into study groups.
rationale
The reason why a study, or something in a study, is being done.
Real World Data (RWD)
Health-related information collected from many different types of records and used for research purposes.
Real World Evidence (RWE)
Findings from analyzing Real World Data.
registry (study)
An organized list of research information.
reimburse
Pay money back to participants for their out-of-pocket study costs.
relative risk
The chance of a harmful event happening in one study group compared with another.
results (study)
Findings from the study.
retrospective study
Research that uses already existing data.
risk-benefit ratio
A comparison of the possible bad and potential good things that could happen if a participant joins a research study.
risks of a research study
The possible harms of being in a research study.

sample size
The number of participants in a study or study group.
schedule of assessments
A chart that lists the study activities and when they will happen during a study.
screening
Tests and questions to find out if a person can join a study.
secondary endpoint
A measure used to answer other important questions in the study that are not the main research question.
sensitivity (medical test)
How well a medical test can accurately identify people who have a disease or trait.
sequential
Happening in a specific order.
side effect
A health change that is not the intended effect of the treatment and usually considered a problem.
single-blind study
A study that is set up so that the study treatment each participant receives is not known by the participants but is known by the researchers.
specificity (medical test)
How well a medical test can accurately identify people who do not have a disease or trait.
sponsor
The group that is in charge of, or pays for, a research study.
standard of care
The usual treatment given to patients for an illness.
statistically significant
Results that are very unlikely to have occurred by chance.
study design
The way a study is set up to answer the study question.
study intervention
A treatment given to the participants in a study
study life cycle
The steps of a research study from beginning to end.
study participant
A person who joins a research study.
study population
All the participants in a study.
study statistician
A person who uses math to help design a study and interpret the data.
substudy
A study with a smaller group of participants already enrolled in the main study.
superiority trial
A study to test if a study treatment works better than another treatment for the same condition.
synergistic effect
When two or more things used together have a greater effect than each thing alone.

treatment effect
How much a study treatment changes a condition, symptom, or function.

umbrella trial
A research study that tests and compares two or more study treatments for one disease or condition.

validate
To confirm that a process or test works as planned, or results are true.
voluntary participation
Choosing to participate in research without feeling pressured.
volunteer (to)
To choose to join a study.

wash-out
A time before starting a study treatment when a person stops taking other medicines.
withdraw
To stop being a participant in a study.

X-ray
A way of taking pictures of the inside of a person's body using X-ray radiation.

Helping you understand clinical research