Research words,
human explanations.
A quick reference for the terms you may hear.
- Adverse event
- An unfavorable health event during a study. It does not automatically mean the study treatment caused it.
- Baseline
- Information collected near the start of participation that can be used for later comparisons.
- Blinding
- Keeping an assigned study treatment unknown to specified people during the study. Also called masking.
- Caregiver
- A person who provides practical, emotional or other support. Ask what role a study permits or requires.
- Clinical trial
- Research in people that studies an intervention, such as a medicine, device or approach to care.
- Compensation
- A payment for study participation under study-specific terms. It is different from reimbursement of a documented expense.
- Consent document
- Written study information used during the informed consent process. Keep the copy provided to you.
- Control group
- A comparison group used to help researchers interpret study findings.
- Eligibility criteria
- The study’s requirements for who may participate. The research team must confirm whether they are met.
- Enrollment
- Joining a study under its specific requirements. An inquiry or prescreening is not the same step.
- Exclusion criteria
- Factors that prevent participation in a particular study, even if other requirements are met.
- Follow-up
- Study contact or assessment after an earlier visit, treatment or participation stage.
- Inclusion criteria
- Requirements a person generally must meet to enter a particular study.
- Informed consent
- The ongoing process of receiving study information, asking questions and deciding whether to participate.
- Institutional Review Board (IRB)
- A committee that reviews human research to help protect participant rights and welfare.
- Investigational product
- A product being studied. Its use in a trial does not by itself mean it is approved for that use.
- NCT number
- The identifier beginning with NCT assigned to a registered study on ClinicalTrials.gov.
- Observational study
- Research that collects information without assigning participants to an intervention as part of the study design.
- Placebo
- An inactive comparison product used in some studies. Ask whether it is part of the study you are considering.
- Principal investigator
- The investigator responsible for the conduct of the study at a research site.
- Protocol
- The written study plan describing its purpose, methods and participation requirements.
- Randomization
- Assigning study groups by chance, rather than by a participant’s or clinician’s choice.
- Reimbursement
- Repayment of an eligible expense under a study’s rules, sometimes requiring receipts or prior approval.
- Screening
- Study-specific checks used to determine whether participation requirements are met.
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