Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term C203912 MRCT Center Clinical Research Glossary MRCT Center Clinical Research Glossary MRCT Center Clinical Research Glossary The terminology relevant to the plain language glossary of the Multi-Regional Clinical Trial (MRCT) Center of Brigham and Women's Hospital and Harvard. CDISC MRCT Center Clinical Research Glossary C203914 C203912 MRCT Center Clinical Research Glossary additive effect The combined effect when two or more things are used together. (https://mrctcenter.org/glossaryterm/additive-effect/) Additive Effect C25729 C203912 MRCT Center Clinical Research Glossary adherence Following the study directions and requirements. (https://mrctcenter.org/glossaryterm/adherence/) Adherence C41331 C203912 MRCT Center Clinical Research Glossary adverse event Any health problem that happens during the study. (https://mrctcenter.org/glossaryterm/adverse-event/) Adverse Event C41332 C203912 MRCT Center Clinical Research Glossary adverse reaction A health problem that happens during the study and is reported as possibly caused by the study treatment. (https://mrctcenter.org/glossaryterm/adverse-reaction/) Adverse Reaction C142392 C203912 MRCT Center Clinical Research Glossary anonymize Remove, change, or hide personal details to protect participant privacy. (https://mrctcenter.org/glossaryterm/anonymize/) Anonymization C16295 C203912 MRCT Center Clinical Research Glossary antibody A protein made by the body to fight an illness or infection. (https://mrctcenter.org/glossaryterm/antibody/) Antibody C268 C203912 MRCT Center Clinical Research Glossary antigen A substance that causes the body's immune system to react. (https://mrctcenter.org/glossaryterm/antigen/) Antigen C15538 C203912 MRCT Center Clinical Research Glossary arm A group of participants in a research study who all receive the same study treatment. (https://mrctcenter.org/glossaryterm/arm/) Protocol Treatment Arm C203934 C203912 MRCT Center Clinical Research Glossary assent form A document used to explain the details of a research study to children or people who are unable to give legal consent. (https://mrctcenter.org/glossaryterm/assent-form/) Assent Form C161418 C203912 MRCT Center Clinical Research Glossary assent Willingness to take part in a research study by someone who is not able to give legal consent. (https://mrctcenter.org/glossaryterm/assent/) Informed Assent C25217 C203912 MRCT Center Clinical Research Glossary assessment Information that is collected and analyzed from a study participant. (https://mrctcenter.org/glossaryterm/assessment/) Assessment C142400 C203912 MRCT Center Clinical Research Glossary baseline assessment Information that is collected and analyzed from a study participant at the start of a study. (https://mrctcenter.org/glossaryterm/baseline-assessment/) Baseline Assessment C209461 C203912 MRCT Center Clinical Research Glossary basket trial A research study that tests one study treatment for different diseases and conditions. (https://mrctcenter.org/glossaryterm/basket-trial/) Basket Trial C203915 C203912 MRCT Center Clinical Research Glossary benefits of a research study The ways a research study might help the participant and others. (https://mrctcenter.org/glossaryterm/benefits-of-a-research-study/) Benefits of a Research Study C28232 C203912 MRCT Center Clinical Research Glossary bias (research) Flaws in the way a study is designed, done, or analyzed that lead to one conclusion being favored over another. (https://mrctcenter.org/glossaryterm/research-bias/) Bias C16342 C203912 MRCT Center Clinical Research Glossary biomarker Something in the body that is measured as an indicator of personal health or disease. (https://mrctcenter.org/glossaryterm/biomarker/) Biomarker C37932 C203912 MRCT Center Clinical Research Glossary birth control A way to prevent pregnancy. (https://mrctcenter.org/glossaryterm/birth-control/) Contraception C28221 C203912 MRCT Center Clinical Research Glossary blood draw Taking a sample of blood by using a needle. (https://mrctcenter.org/glossaryterm/blood-draw/) Phlebotomy C142422 C203912 MRCT Center Clinical Research Glossary clinical benefit A health change that researchers measure to show that the study treatment helps the study participants. (https://mrctcenter.org/glossaryterm/clinical-benefit/) Clinical Benefit C51811 C203912 MRCT Center Clinical Research Glossary Clinical Research Coordinator (CRC) A research staff member who helps manage studies. (https://mrctcenter.org/glossaryterm/clinical-research-coordinator-crc/) Clinical Coordinator C142435 C203912 MRCT Center Clinical Research Glossary clinical research A type of science that uses people's data to study health, illness, behaviors, or conditions in careful and defined ways. (https://mrctcenter.org/glossaryterm/clinical-research/) Clinical Research and Development C71104 C203912 MRCT Center Clinical Research Glossary clinical trial A research study that tests drugs, devices and treatments to see if they are safe and work in people. (https://mrctcenter.org/glossaryterm/clinical-trial/) Clinical Trial C85499 C203912 MRCT Center Clinical Research Glossary clinician A health care provider. (https://mrctcenter.org/glossaryterm/clinician/) Clinician C61512 C203912 MRCT Center Clinical Research Glossary cohort A group of study participants that are similar in some way. (https://mrctcenter.org/glossaryterm/cohort/) Cohort C203916 C203912 MRCT Center Clinical Research Glossary Comparative Effectiveness Research (CER) A study comparing two or more treatments. (https://mrctcenter.org/glossaryterm/comparative-effectiveness-research-cer/) Comparative Effectiveness Research C142458 C203912 MRCT Center Clinical Research Glossary comparator Something that is compared to the study treatment. (https://mrctcenter.org/glossaryterm/comparator/) Comparator C209471 C203912 MRCT Center Clinical Research Glossary compensation (study) Money and other forms of payment that may be given to participants for completing study activities. (https://mrctcenter.org/glossaryterm/compensation-study/) Study Compensation C39490 C203912 MRCT Center Clinical Research Glossary compliance Following research requirements. (https://mrctcenter.org/glossaryterm/compliance/) Patient Compliance C17204 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/computerized-tomography-ct-scan/) Computed Tomography C70902 C203912 MRCT Center Clinical Research Glossary concomitant medications Non-study medicines that are allowed to be taken at the same time as the study treatment. (https://mrctcenter.org/glossaryterm/concomitant-medications/) Concomitant Agent C153144 C203912 MRCT Center Clinical Research Glossary conduct To do a study or procedure. (https://mrctcenter.org/glossaryterm/conduct/) Study Conduct C53324 C203912 MRCT Center Clinical Research Glossary confidence interval The defined range of numbers used to describe where the results are expected to fall. (https://mrctcenter.org/glossaryterm/confidence-interval/) Confidence Interval C16466 C203912 MRCT Center Clinical Research Glossary confidentiality Protecting personal information from people who should not have access. (https://mrctcenter.org/glossaryterm/confidentiality/) Confidentiality C209462 C203912 MRCT Center Clinical Research Glossary confounding When the study outcome is influenced by outside conditions that were not expected by the study researchers. (https://mrctcenter.org/glossaryterm/confounding/) Confounding Variable C16468 C203912 MRCT Center Clinical Research Glossary consent form A document used to explain the planned research before a person decides whether or not to join a study. (https://mrctcenter.org/glossaryterm/consent-form/) Consent Form C54148 C203912 MRCT Center Clinical Research Glossary Contract Research Organization (CRO) A group that is paid by the study sponsor to support research studies. (https://mrctcenter.org/glossaryterm/contract-research-organization-cro/) Contract Research Organization C28143 C203912 MRCT Center Clinical Research Glossary control group The people in a study who do not receive the study treatment or do not have the condition being studied. (https://mrctcenter.org/glossaryterm/control-group/) Control Group C48834 C203912 MRCT Center Clinical Research Glossary correlation When two or more measures are linked. (https://mrctcenter.org/glossaryterm/correlation/) Correlation C142489 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/data-monitoring-committee-data-and-safety-monitoring) Data Monitoring Committee C25474 C203912 MRCT Center Clinical Research Glossary data Information collected from or about people taking part in a research study. (https://mrctcenter.org/glossaryterm/data/) Data C203935 C203912 MRCT Center Clinical Research Glossary database (research) Information that is collected and organized to be used for research. (https://mrctcenter.org/glossaryterm/database-research/) Research Database C142444 C203912 MRCT Center Clinical Research Glossary discontinue (participant) To remove a study participant from a study. (https://mrctcenter.org/glossaryterm/discontinue-participant/) Study Subject Discontinuation C49502 C203912 MRCT Center Clinical Research Glossary discontinue (study treatment) To stop a study treatment in a participant. (https://mrctcenter.org/glossaryterm/discontinue-study-treatment/) Drug Withdrawn C17747 C203912 MRCT Center Clinical Research Glossary disease progression An illness getting worse over time. (https://mrctcenter.org/glossaryterm/disease-progression/) Disease Progression C17751 C203912 MRCT Center Clinical Research Glossary disease-free survival The length of time after treatment that a person lives without the illness coming back. (https://mrctcenter.org/glossaryterm/disease-free-survival/) Disease-Free Survival C90475 C203912 MRCT Center Clinical Research Glossary dose escalation study A kind of study where increasing amounts of a study treatment are given to different groups to find the best dose. (https://mrctcenter.org/glossaryterm/dose-escalation-study/) Titration Study C15228 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/double-blind-study/) Double Blind Study C203919 C203912 MRCT Center Clinical Research Glossary drug holiday A time period decided between the participant and study team when a medication is stopped and then re-started. (https://mrctcenter.org/glossaryterm/drug-holiday/) Drug Holiday C15986 C203912 MRCT Center Clinical Research Glossary drug therapy The use of medicine to treat a disease, condition, or symptom. (https://mrctcenter.org/glossaryterm/drug-therapy/) Pharmacotherapy C203920 C203912 MRCT Center Clinical Research Glossary e-consent (form) An electronic version of an informed consent form. (https://mrctcenter.org/glossaryterm/e-consent-form/) Electronic Consent Form C142522 C203912 MRCT Center Clinical Research Glossary effectiveness How well a treatment works. (https://mrctcenter.org/glossaryterm/effectiveness/) Effectiveness C88183 C203912 MRCT Center Clinical Research Glossary efficacy How well a study treatment works in the study. (https://mrctcenter.org/glossaryterm/efficacy/) Efficacy C16112 C203912 MRCT Center Clinical Research Glossary eligibility criteria The reasons a person can be included in, or excluded from, a study. (https://mrctcenter.org/glossaryterm/eligibility-criteria/) Clinical Trial Eligibility Criteria C96966 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/emergency-use-authorization-eua/) Emergency Use Authorization C25212 C203912 MRCT Center Clinical Research Glossary endpoint A measure of the expected effect of the study treatment. (https://mrctcenter.org/glossaryterm/endpoint/) End Point C37948 C203912 MRCT Center Clinical Research Glossary enroll The action of a participant joining the study after providing informed consent. (https://mrctcenter.org/glossaryterm/enroll/) Enrollment C17843 C203912 MRCT Center Clinical Research Glossary epidemiologist A person who studies where, why, how often, and to what populations health concerns and diseases happen. (https://mrctcenter.org/glossaryterm/epidemiologist/) Epidemiologist C142539 C203912 MRCT Center Clinical Research Glossary equivalence When two or more things in a study are about the same. (https://mrctcenter.org/glossaryterm/equivalence/) Equivalence Trial C203921 C203912 MRCT Center Clinical Research Glossary equivalent (effect) The same or almost the same result. (https://mrctcenter.org/glossaryterm/equivalent-effect/) Equivalent Effect C25370 C203912 MRCT Center Clinical Research Glossary exclusion criteria A list of reasons a person cannot be included in a study. (https://mrctcenter.org/glossaryterm/exclusion-criteria/) Exclusion Criteria C98722 C203912 MRCT Center Clinical Research Glossary expanded access A process for a doctor to request an unapproved treatment for a seriously ill patient. (https://mrctcenter.org/glossaryterm/expanded-access/) Expanded Access Study C147146 C203912 MRCT Center Clinical Research Glossary exploratory research A process to find facts that can guide the design of future studies. (https://mrctcenter.org/glossaryterm/exploratory-research/) Exploratory Research C154589 C203912 MRCT Center Clinical Research Glossary focus group A group interview to learn what people think about a topic. (https://mrctcenter.org/glossaryterm/focus-group/) Focus Group C25515 C203912 MRCT Center Clinical Research Glossary frequency How often something happens over a period of time. (https://mrctcenter.org/glossaryterm/frequency/) Temporal Frequency C142429 C203912 MRCT Center Clinical Research Glossary generalizability How research results can apply to people who were not part of the study. (https://mrctcenter.org/glossaryterm/generalizability/) Clinical Generalizability C15709 C203912 MRCT Center Clinical Research Glossary genetic testing A medical test that could identify a health risk to them or their biological family members by looking at their genes (DNA). (https://mrctcenter.org/glossaryterm/genetic-testing/) Genetic Testing C93150 C203912 MRCT Center Clinical Research Glossary hazard ratio A measure of risk that compares two treatments in the same study. (https://mrctcenter.org/glossaryterm/hazard-ratio/) Hazard Ratio C49651 C203912 MRCT Center Clinical Research Glossary healthy volunteer A study participant who does not have a disease or condition, including the one being studied. (https://mrctcenter.org/glossaryterm/healthy-volunteer/) Healthy Subject C27998 C203912 MRCT Center Clinical Research Glossary hereditary A parent's features and traits being passed to their biological children before birth. (https://mrctcenter.org/glossaryterm/hereditary/) Hereditary C142668 C203912 MRCT Center Clinical Research Glossary hypothesis An idea that is tested in a research study. (https://mrctcenter.org/glossaryterm/hypothesis/) Research Hypothesis C17930 C203912 MRCT Center Clinical Research Glossary immune response The body's reaction to a substance, illness, or infection. (https://mrctcenter.org/glossaryterm/immune-response/) Immune Response Process C16726 C203912 MRCT Center Clinical Research Glossary incidence Number of new cases or events during a period of time. (https://mrctcenter.org/glossaryterm/incidence/) Incidence C25532 C203912 MRCT Center Clinical Research Glossary inclusion criteria A list of requirements a person must meet to take part in a study. (https://mrctcenter.org/glossaryterm/inclusion-criteria/) Inclusion Criteria C16735 C203912 MRCT Center Clinical Research Glossary informed consent The process of learning and discussing the details of a research study before deciding whether to take part. (https://mrctcenter.org/glossaryterm/informed-consent/) Informed Consent C15388 C203912 MRCT Center Clinical Research Glossary infusion A way to give a fluid to the study participant, usually through a vein. (https://mrctcenter.org/glossaryterm/infusion/) Infusion Procedure C16741 C203912 MRCT Center Clinical Research Glossary Institutional Review Board (IRB) A team of people who review studies to protect the rights and welfare of study participants. (https://mrctcenter.org/glossaryterm/institutional-review-board-irb/) Institutional Review Board C202579 C203912 MRCT Center Clinical Research Glossary investigational medicine A treatment or drug that is not yet approved for the condition being studied. (https://mrctcenter.org/glossaryterm/investigational-medicine/) Investigational Medicinal Product C96090 C203912 MRCT Center Clinical Research Glossary Investigational New Drug (IND) application An application to the United States Food & Drug Administration (FDA) to get permission to use a drug in a research study that enrolls people. (https://mrctcenter.org/glossaryterm/investigational-new-drug-ind-application/) Investigational New Drug Application C41161 C203912 MRCT Center Clinical Research Glossary investigational product A drug, device, vaccine or other treatment being tested in a study. (https://mrctcenter.org/glossaryterm/investigational-product/) Protocol Agent C25936 C203912 MRCT Center Clinical Research Glossary investigator A person who leads a research study. (https://mrctcenter.org/glossaryterm/investigator/) Investigator C15273 C203912 MRCT Center Clinical Research Glossary longitudinal study Research that collects data from the same participants over a long time. (https://mrctcenter.org/glossaryterm/longitudinal-study/) Longitudinal Study C16809 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/magnetic-resonance-imaging-mri/) Magnetic Resonance Imaging C165770 C203912 MRCT Center Clinical Research Glossary master protocol An overall research plan that guides sub-studies that have their own research questions. (https://mrctcenter.org/glossaryterm/master-protocol/) Master Protocol C25564 C203912 MRCT Center Clinical Research Glossary maximum The most or largest amount. (https://mrctcenter.org/glossaryterm/maximum/) Maximum C53319 C203912 MRCT Center Clinical Research Glossary mean The average. (https://mrctcenter.org/glossaryterm/mean/) Arithmetic Mean C28007 C203912 MRCT Center Clinical Research Glossary median The middle number in a set of numbers when listed in order from lowest to highest. (https://mrctcenter.org/glossaryterm/median/) Median C25570 C203912 MRCT Center Clinical Research Glossary minimal minimum Very small. (https://mrctcenter.org/glossaryterm/minimal/) Minimum C156663 C203912 MRCT Center Clinical Research Glossary minor Someone considered too young to give legal consent. (https://mrctcenter.org/glossaryterm/minor/) Minor Person C61256 C203912 MRCT Center Clinical Research Glossary monitor To observe, check or evaluate something in a study over time. (https://mrctcenter.org/glossaryterm/monitor/) Monitoring C184382 C203912 MRCT Center Clinical Research Glossary morbidity (rate) The number of people who develop a disease or illness in a group over time. (https://mrctcenter.org/glossaryterm/morbidity-rate/) Morbidity Rate C16880 C203912 MRCT Center Clinical Research Glossary mortality (rate) The number of deaths in a group of people over time. (https://mrctcenter.org/glossaryterm/mortality-rate/) Mortality Rate C16104 C203912 MRCT Center Clinical Research Glossary multicenter trial A study that takes place at more than one research center. (https://mrctcenter.org/glossaryterm/multicenter-trial/) Multi-Institutional Clinical Trial C35681 C203912 MRCT Center Clinical Research Glossary negative test result A test result that shows a person does not have what was tested for. (https://mrctcenter.org/glossaryterm/negative-test-result/) Negative Test Result C203922 C203912 MRCT Center Clinical Research Glossary negligible So small that it has little to no impact. (https://mrctcenter.org/glossaryterm/negligible/) Negligible C201294 C203912 MRCT Center Clinical Research Glossary non-compliance Not following research requirements. (https://mrctcenter.org/glossaryterm/non-compliance/) Subject Noncompliance C184386 C203912 MRCT Center Clinical Research Glossary non-inferiority trial A study to test if a study treatment works about as well as another treatment for the same condition. (https://mrctcenter.org/glossaryterm/non-inferiority-trial/) Non-Inferiority Trial C142450 C203912 MRCT Center Clinical Research Glossary objective A purpose or goal of a study. (https://mrctcenter.org/glossaryterm/objective/) Clinical Trial Objective C16084 C203912 MRCT Center Clinical Research Glossary observational study A study that collects health information about study participants without giving a treatment. (https://mrctcenter.org/glossaryterm/observational-study/) Observational Study C16932 C203912 MRCT Center Clinical Research Glossary odds ratio The chance of a health event happening in one group compared with the chance of the same event happening in another group. (https://mrctcenter.org/glossaryterm/odds-ratio/) Odds Ratio C125600 C203912 MRCT Center Clinical Research Glossary off-label The use of a treatment in a different way or for a condition other than what it is approved for. (https://mrctcenter.org/glossaryterm/off-label/) Off-Label Treatment C49659 C203912 MRCT Center Clinical Research Glossary open-label A type of study where participants and research staff know which treatment participants are being given. (https://mrctcenter.org/glossaryterm/open-label/) Open Label Study C204098 C203912 MRCT Center Clinical Research Glossary outcome (of study) A description of the overall results of the study. (https://mrctcenter.org/glossaryterm/outcome-of-study/) Study Outcome Description C93407 C203912 MRCT Center Clinical Research Glossary outcome measure The way that a study endpoint is measured. (https://mrctcenter.org/glossaryterm/outcome-measure/) Study Outcome Measurement C44185 C203912 MRCT Center Clinical Research Glossary p-value (probability value) A number that researchers use to show that a result did not occur by chance. (https://mrctcenter.org/glossaryterm/p-value-probability-value/) P-Value C95401 C203912 MRCT Center Clinical Research Glossary Patient Reported Outcomes (PROs) The information that patients share about their own health or well-being to answer questions in a study. (https://mrctcenter.org/glossaryterm/patient-reported-outcomes-pros/) Patient Reported Outcome C16963 C203912 MRCT Center Clinical Research Glossary peer review Evaluation by independent experts. (https://mrctcenter.org/glossaryterm/peer-review/) Peer Review C49662 C203912 MRCT Center Clinical Research Glossary Pharmacodynamic (PD) study A study that measures the effects of a drug on the human body. (https://mrctcenter.org/glossaryterm/pharmacodynamic-pd-study/) Pharmacodynamic Study C15299 C203912 MRCT Center Clinical Research Glossary Pharmacokinetic (PK) study A study that measures what happens to a drug in a person's body over time. (https://mrctcenter.org/glossaryterm/pharmacokinetic-pk-study/) Pharmacokinetics C142637 C203912 MRCT Center Clinical Research Glossary pharmacovigilance A process to detect, review, and make decisions about drug safety to protect patients. (https://mrctcenter.org/glossaryterm/pharmacovigilance/) Pharmacovigilance C48281 C203912 MRCT Center Clinical Research Glossary phase A step in the overall clinical research process to test a new drug, device, or treatment. (https://mrctcenter.org/glossaryterm/phase/) Trial Phase C15303 C203912 MRCT Center Clinical Research Glossary pilot study A small study that is done to test a process before starting a larger study. (https://mrctcenter.org/glossaryterm/pilot-study/) Pilot Study C753 C203912 MRCT Center Clinical Research Glossary placebo Something that looks like the treatment being studied, but doesn't contain any medicine. (https://mrctcenter.org/glossaryterm/placebo/) Placebo C203925 C203912 MRCT Center Clinical Research Glossary placebo-controlled study A study with two or more groups where one group is given a placebo. (https://mrctcenter.org/glossaryterm/placebo-controlled-study/) Placebo-Controlled Study C209468 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/platform-trial/) Platform Trial C38758 C203912 MRCT Center Clinical Research Glossary positive test result A test result that shows a person has what was tested for. (https://mrctcenter.org/glossaryterm/positive-test-result/) Positive Finding C142640 C203912 MRCT Center Clinical Research Glossary post-market surveillance Continuing to collect and analyze information about the risks and benefits of medicine and devices after they have been approved for patient use. (https://mrctcenter.org/glossaryterm/post-market-surveillance/) Postmarketing Surveillance C187706 C203912 MRCT Center Clinical Research Glossary post-trial access When participants can still receive a study treatment after their participation has ended. (https://mrctcenter.org/glossaryterm/post-trial-access/) Continued Access Study C142642 C203912 MRCT Center Clinical Research Glossary preclinical study A study to test a treatment in the lab or in animals before testing it in people. (https://mrctcenter.org/glossaryterm/preclinical-study/) Preclinical Study C17010 C203912 MRCT Center Clinical Research Glossary prevalence Number of known cases or events in a group. (https://mrctcenter.org/glossaryterm/prevalence/) Prevalence C94496 C203912 MRCT Center Clinical Research Glossary primary endpoint A study measure that is used to answer the main research question. (https://mrctcenter.org/glossaryterm/primary-endpoint/) Primary Endpoint C54154 C203912 MRCT Center Clinical Research Glossary probability The likelihood or chance that something might happen. (https://mrctcenter.org/glossaryterm/probability/) Probability C98769 C203912 MRCT Center Clinical Research Glossary procedures (for participants) The activities that participants will be asked to do during the research study. (https://mrctcenter.org/glossaryterm/procedures-for-participants/) Physical Medical Procedure C28234 C203912 MRCT Center Clinical Research Glossary progression-free survival The length of time without a person's illness getting worse. (https://mrctcenter.org/glossaryterm/progression-free-survival/) Progression-free Survival C142646 C203912 MRCT Center Clinical Research Glossary prospective study Research that uses new data collected from participants. (https://mrctcenter.org/glossaryterm/prospective-study/) Prospective Study C142451 C203912 MRCT Center Clinical Research Glossary protocol A complete description of the research plan and procedures. (https://mrctcenter.org/glossaryterm/protocol/) Clinical Trial Protocol C119264 C203912 MRCT Center Clinical Research Glossary proxy A person who is legally allowed to make research decisions for someone else. (https://mrctcenter.org/glossaryterm/proxy/) Proxy C142654 C203912 MRCT Center Clinical Research Glossary pseudonymize Replace personal details with a code so that data are protected. (https://mrctcenter.org/glossaryterm/pseudonymized/) Pseudonymization C17047 C203912 MRCT Center Clinical Research Glossary Quality of Life (QOL) How someone feels and functions day to day. (https://mrctcenter.org/glossaryterm/quality-of-life-qol/) Quality of Life C17048 C203912 MRCT Center Clinical Research Glossary questionnaire A list of questions for study participants to answer as part of the study. (https://mrctcenter.org/glossaryterm/questionnaire/) Questionnaire C25196 C203912 MRCT Center Clinical Research Glossary randomization A way to use chance to place study participants into different study treatment groups. (https://mrctcenter.org/glossaryterm/randomization/) Randomization C46079 C203912 MRCT Center Clinical Research Glossary randomized controlled trial Research that uses chance for participants to be assigned to the study treatment group or a comparison group. (https://mrctcenter.org/glossaryterm/randomized-controlled-trial/) Randomized Controlled Clinical Trial C165830 C203912 MRCT Center Clinical Research Glossary Real World Data (RWD) Information from many different sources used for health research purposes. (https://mrctcenter.org/glossaryterm/real-world-data-rwd/) Real-world Data C165831 C203912 MRCT Center Clinical Research Glossary Real World Evidence (RWE) Findings from analyzing real world data. (https://mrctcenter.org/glossaryterm/real-world-evidence-rwe/) Real-world Evidence C93453 C203912 MRCT Center Clinical Research Glossary registry (study) An organized list of research information. (https://mrctcenter.org/glossaryterm/registry-study/) Study Registry C93152 C203912 MRCT Center Clinical Research Glossary relative risk The chance of a harmful event happening in one study group compared to another. (https://mrctcenter.org/glossaryterm/relative-risk/) Relative Risk C203936 C203912 MRCT Center Clinical Research Glossary repository (research) A collection of participant data and samples stored for future research. (https://mrctcenter.org/glossaryterm/repository-research/) Research Repository C203930 C203912 MRCT Center Clinical Research Glossary results (study) Findings from the study. (https://mrctcenter.org/glossaryterm/results-study/) Study Results C53312 C203912 MRCT Center Clinical Research Glossary retrospective study Research that uses already existing data. (https://mrctcenter.org/glossaryterm/retrospective-study/) Retrospective Study C203928 C203912 MRCT Center Clinical Research Glossary risk-benefit ratio A comparison of the possible bad and potential good things that could happen if a participant joins a research study. (https://mrctcenter.org/glossaryterm/risk-benefit-ratio/) Risk-Benefit Ratio C142718 C203912 MRCT Center Clinical Research Glossary risks of a research study The possible harms of being in a research study. (https://mrctcenter.org/glossaryterm/risks-of-a-research-study/) Subject Risk C53190 C203912 MRCT Center Clinical Research Glossary sample size The number of participants in a study or study group. (https://mrctcenter.org/glossaryterm/sample-size/) Sample Size C142678 C203912 MRCT Center Clinical Research Glossary schedule of assessments A chart that lists the study activities and when they will happen during a study. (https://mrctcenter.org/glossaryterm/schedule-of-assessments/) Schedule Of Assessments C48262 C203912 MRCT Center Clinical Research Glossary screening Tests and questions to find out if a person can join a study. (https://mrctcenter.org/glossaryterm/screening/) Trial Screening C139173 C203912 MRCT Center Clinical Research Glossary secondary endpoint A measure used to answer other important questions in the study that are not the main research question. (https://mrctcenter.org/glossaryterm/secondary-endpoint/) Secondary Endpoint C41394 C203912 MRCT Center Clinical Research Glossary sensitivity (medical test) How well a medical test can accurately identify people who have a disease or trait. (https://mrctcenter.org/glossaryterm/sensitivity-medical-test/) Diagnostic Sensitivity C41335 C203912 MRCT Center Clinical Research Glossary Serious Adverse Event (SAE) A health issue that happens during a study, and can lead to hospital care, lasting medical problems, life-threatening conditions, or death. (https://mrctcenter.org/glossaryterm/serious-adverse-event-sae/) Serious Adverse Event C2861 C203912 MRCT Center Clinical Research Glossary side effect A health change that is not the intended effect of the treatment and usually considered a problem. (https://mrctcenter.org/glossaryterm/side-effect/) Side Effect C28233 C203912 MRCT Center Clinical Research Glossary 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. (https://mrctcenter.org/glossaryterm/single-blind-study/) Single Blind Study C41395 C203912 MRCT Center Clinical Research Glossary specificity (medical test) How well a medical test can accurately identify people who do not have a disease or trait. (https://mrctcenter.org/glossaryterm/specificity-medical-test/) Diagnostic Specificity C70793 C203912 MRCT Center Clinical Research Glossary sponsor The group that is in charge of, or pays for, a research study. (https://dev.mrctcenter.org/glossaryterm/sponsor-3/) Clinical Study Sponsor C94396 C203912 MRCT Center Clinical Research Glossary standard of care The usual treatment given to patients for an illness. (https://mrctcenter.org/glossaryterm/standard-of-care/) Best Practice C61040 C203912 MRCT Center Clinical Research Glossary statistically significant Results that are very unlikely to have occurred by chance. (https://mrctcenter.org/glossaryterm/statistically-significant/) Statistical Significance C15320 C203912 MRCT Center Clinical Research Glossary study design The way a study is set up to answer the study question. (https://mrctcenter.org/glossaryterm/study-design/) Study Design C209473 C203912 MRCT Center Clinical Research Glossary study feasibility How likely it is that a study can be completed. (https://mrctcenter.org/glossaryterm/study-feasibility/) Study Feasibility C25218 C203912 MRCT Center Clinical Research Glossary study intervention A treatment given to the participants in a study. (https://mrctcenter.org/glossaryterm/study-intervention/) Clinical Intervention or Procedure C203929 C203912 MRCT Center Clinical Research Glossary study life cycle The steps of a research study from beginning to end. (https://mrctcenter.org/glossaryterm/study-life-cycle/) Study Life Cycle C142710 C203912 MRCT Center Clinical Research Glossary study participant A person who joins a research study. (https://mrctcenter.org/glossaryterm/study-participant/) Study Participant C70833 C203912 MRCT Center Clinical Research Glossary study population All the participants in a study. (https://mrctcenter.org/glossaryterm/study-population/) Study Population C142737 C203912 MRCT Center Clinical Research Glossary study statistician A person who uses math to help design a study and interpret the data. (https://mrctcenter.org/glossaryterm/study-statistician/) Trial Statistician C198230 C203912 MRCT Center Clinical Research Glossary substudy A study with a smaller group of participants already enrolled in the main study. (https://mrctcenter.org/glossaryterm/substudy/) Substudy C142722 C203912 MRCT Center Clinical Research Glossary superiority trial A study to test if a study treatment works better than another treatment for the same condition. (https://mrctcenter.org/glossaryterm/superiority-trial/) Superiority Trial C203931 C203912 MRCT Center Clinical Research Glossary synergistic effect When two or more things combined have a greater effect than when their individual effects are added together. (https://mrctcenter.org/glossaryterm/synergistic-effect/) Synergistic Effect C203932 C203912 MRCT Center Clinical Research Glossary tolerability How much a participant or group of participants can accept a study treatment's unwanted effects so they can keep taking it. (https://mrctcenter.org/glossaryterm/tolerability/) Study Intervention Tolerability C209469 C203912 MRCT Center Clinical Research Glossary treatment effect How much a study treatment changes a condition, symptom, or function. ((https://mrctcenter.org/glossaryterm/treatment-effect/) Treatment Effect C209470 C203912 MRCT Center Clinical Research Glossary umbrella trial A research study that tests and compares two or more study treatments for one disease or condition. (https://mrctcenter.org/glossaryterm/umbrella-trial/) Umbrella Trial C203933 C203912 MRCT Center Clinical Research Glossary voluntary participation Choosing to participate in research without feeling pressured. (https://mrctcenter.org/glossaryterm/voluntary-participation/) Voluntary Participation C42872 C203912 MRCT Center Clinical Research Glossary wash-out A time before starting a study treatment when a person stops taking other medicines. (https://mrctcenter.org/glossaryterm/wash-out/) Washout Period C49634 C203912 MRCT Center Clinical Research Glossary withdraw To stop being a participant in a study. (https://mrctcenter.org/glossaryterm/withdraw/) Withdrawal by Subject C38101 C203912 MRCT Center Clinical Research Glossary X-ray A way of taking pictures of the inside of a person's body using X-ray radiation. (https://mrctcenter.org/glossaryterm/x-ray/) X-Ray Imaging