Words & Definitions Commonly Used in Clinical Research
Adverse Event
An experience or abnormal finding that takes place during a clinical study and was harmful to the participant.
Assent
A child's agreement to participate in a clinical study.
Blinded studies
In many studies, some participants receive the new drug, and other participants receive a placebo. A placebo looks just like the drug, but is an inactive substance. A double blind clinical study is when neither researcher nor participant knows who is getting placebo and who is getting the drug. A single blind study is when participants do not know whether they are getting placebo or drug, but the study team does know.
Clinical investigation or study or trial
Research project designed to test the safety and/or effectiveness of drugs, medical devices, procedures, or preventions in human participants.
Confidentiality
Assuring that information about participants is kept secret such that access is limited to appropriate (authorized) persons.
Control group
Study participants who receive either standard procedure for the illness or placebo (no medicine) as compared to study participants who are receiving a new drug, medical device, procedure, or prevention.
Data
Recorded information (about a participant) (e.g., contents of a medical chart).
Data Privacy
The ability to control the availability of information about a participant to others.
Effectiveness
See Efficacy.
Efficacy
If researchers show that a drug has 'efficacy' (or is 'efficacious'), they show that it improves a disease or condition in a controlled environment, like a laboratory. Proving efficacy is a first step to show that the drug can work when it is taken in the right way. If researchers show that a drug is 'effective', they show that it improves a disease or condition outside of a controlled environment. For instance, if a drug lowers cholesterol in a study, it is efficacious. But if that drug has to be taken exactly 1 hour after eating, it might not be effective because it is too hard for people to remember to take it at exactly the right time.
Experimental group
Study participants who receive the new drug, device, procedure, or prevention that is being researched. This group is often compared to a 'control group', which does not receive the new drug, device, procedure, or prevention.
Family Member
Usually a spouse, child (natural, step or adopted), parent, sibling (sister or brother), in-laws, or grandchild.
FDA (Food and Drug Administration)
The U.S. government agency that (1) enforces laws on the manufacturing, tests, and use of drugs and medical devices and (2) approves a new drug or device before it is made available to the public.
Human subject
A participant who volunteers to be in a clinical study.
Informed consent
A participant's written agreement (signed and dated) to be in a clinical study after fully discussing complete and important information about the clinical study with the researchers (investigator and study coordinator):
Inpatient
A person who enters a hospital and stays for one night or more. Procedures or studies that require an overnight stay may be called 'inpatient'.
Institutional Review Board (IRB)
An independent committee that reviews clinical studies involving human subjects (participants) and assures the protection of their safety, rights, privacy and welfare.
Investigation
See clinical investigation
Investigational or experimental device
New medical device that has not been approved by the U.S. Food and Drug Administration (FDA).
Investigational or experimental drug
New drug that has not been approved by the U.S. Food and Drug Administration (FDA)
Investigator
The person in charge of carrying out a clinical study. May also be referred to as "principal investigator."
Nurse Practitioner
A registered nurse (RN) with advanced educational or clinical training. Nurse Practitioners are licensed by the state and authorized to perform many types of care previously only available from doctors. For instance, in many states, Nurse Practitioners can prescribe medications.
Out Patient
Studies or procedures that do not require an overnight stay may be called 'outpatient'. A person who enters a medical facility but does not stay overnight may be called an 'outpatient' as well.
Participant
Another word that can be used for "human subject."
Patient
A person seeking medical care. Participants in clinical studies are not called 'patients', because they may not be receiving medical care. For instance, they may be receiving a new drug that has not yet been proven to work, or they may be receiving a placebo.
Placebo
A placebo looks like a drug, but is actually an inactive substance that is not expected to have any effect on your health. Sometimes a placebo is called a 'dummy pill' or 'sugar pill'. Old placebos were often true 'sugar pills', but modern placebos usually do not contain sugar. A research study may also use a placebo for a medical device or procedure. For instance, a placebo device could look like the real device, but not actually function.
Procedure
A procedure is any process that has to do with treating, assessing, testing, or preventing disease. An experimental procedure is one that has not yet been shown to work.
Protected Health Information (PHI)
Individually identifiable health information (e.g., date of birth) about a participant.
Protocol
A written plan for a clinical study which includes what will be done, when, how, and why.
Random assignment
A chance method, like flipping a coin or pulling numbers out of a hat, that assigns a participant to an experimental group or to a control group in a clinical study
Research
Standard investigations designed to develop or add to general knowledge.
Researcher
Another word that can be used for "investigator". An investigator may or may not be a doctor.
Sponsor
A company, institution, group, foundation, or government agency that funds (provides money) for a clinical study.
Study
See clinical investigation.
Study Coordinator
A person who assists the investigator in conducting a clinical study.
