CDISC MRCT Controlled Terminology

CDISC MRCT Controlled Terminology, 2024-03-29
Legend:
CodeList
CodeListItem
NCI attributes
C203912MRCT Center Clinical Research Glossary

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C203912.MRCT Center Clinical Research GlossaryMRCT Center Clinical Research Glossary
(MRCT Center Clinical Research Glossary)
text
Extensible:
C203912MRCT Center Clinical Research GlossaryThe 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
additive effectC203914The combined effect when two or more things are used together. (https://mrctcenter.org/glossaryterm/additive-effect/)Additive Effect
adherenceC25729Following the study directions and requirements. (https://mrctcenter.org/glossaryterm/adherence/)Adherence
adverse eventC41331Any health problem that happens during the study. (https://mrctcenter.org/glossaryterm/adverse-event/)Adverse Event
adverse reactionC41332A 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
anonymizeC142392Remove, change, or hide personal details to protect participant privacy. (https://mrctcenter.org/glossaryterm/anonymize/)Anonymization
antigenC268A substance that causes the body's immune system to react. (https://mrctcenter.org/glossaryterm/antigen/)Antigen
armC15538A group of participants in a research study who all receive the same study treatment. (https://mrctcenter.org/glossaryterm/arm/)Protocol Treatment Arm
assent formC203934A 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
assentC161418Willingness to take part in a research study by someone who is not able to give legal consent. (https://mrctcenter.org/glossaryterm/assent/)Informed Assent
assessmentC25217Information that is collected and analyzed from a study participant. (https://mrctcenter.org/glossaryterm/assessment/)Assessment
baseline assessmentC142400Information that is collected and analyzed from a study participant at the start of a study. (https://mrctcenter.org/glossaryterm/baseline-assessment/)Baseline Assessment
basket trialC165823A research study that tests one study treatment for different diseases and conditions. (https://mrctcenter.org/glossaryterm/basket-trial/)Basket Protocol
benefits of a research studyC203915The ways a research study might help the participant and others. (https://mrctcenter.org/glossaryterm/benefits-of-a-research-study/)Benefits of a Research Study
bias (research)C28232Flaws 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
biomarkerC16342Something in the body that is measured as an indicator of personal health or disease. (https://mrctcenter.org/glossaryterm/biomarker/)Biomarker
birth controlC37932A way to prevent pregnancy. (https://mrctcenter.org/glossaryterm/birth-control/)Contraception
blood drawC17610Taking a sample of blood by using a needle. (https://mrctcenter.org/glossaryterm/blood-draw/)Blood Sample
clinical benefitC142422A health change that researchers measure to show that the study treatment helps the study participants. (https://mrctcenter.org/glossaryterm/clinical-benefit/)Clinical Benefit
Clinical Research Coordinator (CRC)C51811A research staff member who helps manage studies. (https://mrctcenter.org/glossaryterm/clinical-research-coordinator-crc/)Clinical Coordinator
clinical researchC142435A controlled method of studying health and illness in people. (https://mrctcenter.org/glossaryterm/clinical-research/)Clinical Research and Development
clinical trialC71104A 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
clinicianC85499A health care provider. (https://mrctcenter.org/glossaryterm/clinician/)Clinician
cohortC61512A group of study participants that are similar in some way. (https://mrctcenter.org/glossaryterm/cohort/)Cohort
Comparative Effectiveness Research (CER)C203916A study comparing two or more treatments. (https://mrctcenter.org/glossaryterm/comparative-effectiveness-research-cer/)Comparative Effectiveness Research
complianceC39490Following research requirements. (https://mrctcenter.org/glossaryterm/compliance/)Patient Compliance
Computerized Tomography (CT) scanC17204A 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
conductC153144To do a study or procedure. (https://mrctcenter.org/glossaryterm/conduct/)Study Conduct
confidence intervalC53324The defined range of numbers used to describe where the results are expected to fall. (https://mrctcenter.org/glossaryterm/confidence-interval/)Confidence Interval
confidentialityC16466Protecting personal information from people who should not have access. (https://mrctcenter.org/glossaryterm/confidentiality/)Confidentiality
confoundingC203917When the study outcome is influenced by outside conditions that were not expected by the study researchers. (https://mrctcenter.org/glossaryterm/confounding/)Confound
consent formC16468A 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
Contract Research Organization (CRO)C54148A group that is paid by the study sponsor to support research studies. (https://mrctcenter.org/glossaryterm/contract-research-organization-cro/)Contract Research Organization
control groupC28143The 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
correlationC48834When two or more measures are linked. (https://mrctcenter.org/glossaryterm/correlation/)Correlation
Data Monitoring Committee/Data and Safety Monitoring Board (DMC/DSMB)C142489An 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
dataC25474Information collected from or about people taking part in a research study. (https://mrctcenter.org/glossaryterm/data/)Data
discontinue (participant)C142444To remove a study participant from a study. (https://mrctcenter.org/glossaryterm/discontinue-participant/)Study Subject Discontinuation
discontinue (study treatment)C49502To stop a study treatment in a participant. (https://mrctcenter.org/glossaryterm/discontinue-study-treatment/)Drug Withdrawn
disease progressionC17747An illness getting worse over time. (https://mrctcenter.org/glossaryterm/disease-progression/)Disease Progression
disease-free survivalC17751The length of time after treatment that a person lives without the illness coming back. (https://mrctcenter.org/glossaryterm/disease-free-survival/)Disease-Free Survival
dose escalation studyC90475A 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
double-blind studyC15228A 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
e-consent (form)C203920An electronic version of an informed consent form. (https://mrctcenter.org/glossaryterm/e-consent-form/)Electronic Consent Form
effectivenessC142522How well a treatment works. (https://mrctcenter.org/glossaryterm/effectiveness/)Effectiveness
efficacyC88183How well a study treatment works in the study. (https://mrctcenter.org/glossaryterm/efficacy/)Efficacy
eligibility criteriaC16112The reasons a person can be included in, or excluded from, a study. (https://mrctcenter.org/glossaryterm/eligibility-criteria/)Clinical Trial Eligibility Criteria
Emergency Use Authorization (EUA)C96966A 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
endpointC25212A measure of the expected effect of the study treatment. (https://mrctcenter.org/glossaryterm/endpoint/)End Point
enrollC37948The action of a participant joining the study after providing informed consent. (https://mrctcenter.org/glossaryterm/enroll/)Enrollment
epidemiologistC17843A person who studies where, why, how often, and to what populations health concerns and diseases happen. (https://mrctcenter.org/glossaryterm/epidemiologist/)Epidemiologist
equivalenceC142539When two or more things in a study are about the same. (https://mrctcenter.org/glossaryterm/equivalence/)Equivalence Trial
equivalent (effect)C203921The same or almost the same result. (https://mrctcenter.org/glossaryterm/equivalent-effect/)Equivalent Effect
exclusion criteriaC25370A list of reasons a person cannot be included in a study. (https://mrctcenter.org/glossaryterm/exclusion-criteria/)Exclusion Criteria
expanded accessC98722A process for a doctor to request an unapproved treatment for a seriously ill patient. (https://mrctcenter.org/glossaryterm/expanded-access/)Expanded Access Study
exploratory researchC147146A process to find facts that can guide the design of future studies. (https://mrctcenter.org/glossaryterm/exploratory-research/)Exploratory Research
frequencyC25515How often something happens over a period of time. (https://mrctcenter.org/glossaryterm/frequency/)Temporal Frequency
generalizabilityC142429How research results can apply to people who were not part of the study. (https://mrctcenter.org/glossaryterm/generalizability/)Clinical Generalizability
hazard ratioC93150A measure of risk that compares two treatments in the same study. (https://mrctcenter.org/glossaryterm/hazard-ratio/)Hazard Ratio
healthy volunteerC49651A study participant who does not have a disease or condition, including the one being studied. (https://mrctcenter.org/glossaryterm/healthy-volunteer/)Healthy Subject
hereditaryC27998A parent's features and traits being passed to their biological children before birth. (https://mrctcenter.org/glossaryterm/hereditary/)Hereditary
hypothesisC142668An idea that is tested in a research study. (https://mrctcenter.org/glossaryterm/hypothesis/)Research Hypothesis
incidenceC16726Number of new cases or events during a period of time. (https://mrctcenter.org/glossaryterm/incidence/)Incidence
inclusion criteriaC25532A list of requirements a person must meet to take part in a study. (https://mrctcenter.org/glossaryterm/inclusion-criteria/)Inclusion Criteria
informed consentC16735The 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
infusionC15388A way to give a fluid to the study participant, usually through a vein. (https://mrctcenter.org/glossaryterm/infusion/)Infusion Procedure
Institutional Review Board (IRB)C16741A 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
investigational medicineC202579A treatment or drug that is not yet approved for the condition being studied. (https://mrctcenter.org/glossaryterm/investigational-medicine/)Investigational Medicinal Product
investigational productC41161A drug, device, vaccine or other treatment being tested in a study. (https://mrctcenter.org/glossaryterm/investigational-product/)Protocol Agent
investigatorC25936A person who leads a research study. (https://mrctcenter.org/glossaryterm/investigator/)Investigator
longitudinal studyC15273Research that collects data from the same participants over a long time. (https://mrctcenter.org/glossaryterm/longitudinal-study/)Longitudinal Study
Magnetic Resonance Imaging (MRI)C16809A 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
maximumC25564The most or largest amount. (https://mrctcenter.org/glossaryterm/maximum/)Maximum
meanC53319The average. (https://mrctcenter.org/glossaryterm/mean/)Arithmetic Mean
medianC28007The middle number in a set of numbers when listed in order from lowest to highest. (https://mrctcenter.org/glossaryterm/median/)Median
minimalC25570minimumVery small. (https://mrctcenter.org/glossaryterm/minimal/)Minimum
monitorC61256To observe, check or evaluate something in a study over time. (https://mrctcenter.org/glossaryterm/monitor/)Monitoring
morbidity (rate)C184382The number of people who develop a disease or illness in a group over time. (https://mrctcenter.org/glossaryterm/morbidity-rate/)Morbidity Rate
mortality (rate)C16880The number of deaths in a group of people over time. (https://mrctcenter.org/glossaryterm/mortality-rate/)Mortality Rate
multicenter trialC16104A study that takes place at more than one research center. (https://mrctcenter.org/glossaryterm/multicenter-trial/)Multi-Institutional Clinical Trial
negative test resultC35681A test result that shows a person does not have what was tested for. (https://mrctcenter.org/glossaryterm/negative-test-result/)Negative Test Result
negligibleC203922So small that it has little to no impact. (https://mrctcenter.org/glossaryterm/negligible/)Negligible
non-complianceC91752Not following research requirements. (https://mrctcenter.org/glossaryterm/non-compliance/)Patient Noncompliance
non-inferiority trialC184386A 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 Study
objectiveC142450A purpose or goal of a study. (https://mrctcenter.org/glossaryterm/objective/)Clinical Trial Objective
observational studyC16084A study that collects health information about study participants without giving a treatment. (https://mrctcenter.org/glossaryterm/observational-study/)Observational Study
odds ratioC16932The 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
off-labelC125600The 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
open-labelC49659A type of study where participants and research staff know which treatment participants are being given. (https://mrctcenter.org/glossaryterm/open-label/)Open Label Study
outcome (of study)C204098A description of the overall results of the study. (https://mrctcenter.org/glossaryterm/outcome-of-study/)Study Outcome
outcome measureC93407The way that a study endpoint is measured. (https://mrctcenter.org/glossaryterm/outcome-measure/)Study Outcome Measurement
p-value (probability value)C44185A number that researchers use to show that a result did not occur by chance. (https://mrctcenter.org/glossaryterm/p-value-probability-value/)P-Value
Patient Reported Outcomes (PROs)C95401The 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
peer reviewC16963Evaluation by independent experts. (https://mrctcenter.org/glossaryterm/peer-review/)Peer Review
Pharmacodynamic (PD) studyC49662A study that measures the effects of a drug on the human body. (https://mrctcenter.org/glossaryterm/pharmacodynamic-pd-study/)Pharmacodynamic Study
Pharmacokinetic (PK) studyC15299A study that measures what happens to a drug in a person’s body over time. (https://mrctcenter.org/glossaryterm/pharmacokinetic-pk-study/)Pharmacokinetics
pharmacovigilanceC142637A process to detect, review, and make decisions about drug safety to protect patients. (https://mrctcenter.org/glossaryterm/pharmacovigilance/)Pharmacovigilance
phaseC48281A step in the overall clinical research process to test a new drug, device, or treatment. (https://mrctcenter.org/glossaryterm/phase/)Trial Phase
placeboC753Something that looks like the treatment being studied, but doesn't contain any medicine. (https://mrctcenter.org/glossaryterm/placebo/)Placebo
placebo-controlled studyC203925A study with two or more groups where one group is given a placebo. (https://mrctcenter.org/glossaryterm/placebo-controlled-study/)Placebo-Controlled Study
platform trialC165829A 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 Protocol
positive test resultC38758A test result that shows a person has what was tested for. (https://mrctcenter.org/glossaryterm/positive-test-result/)Positive Finding
post-trial accessC187706When participants can still receive a study treatment after their participation has ended. (https://mrctcenter.org/glossaryterm/post-trial-access/)Continued Access Study
preclinical studyC142642A study to test a treatment in the lab or in animals before testing it in people. (https://mrctcenter.org/glossaryterm/preclinical-study/)Preclinical Study
prevalenceC17010Number of known cases or events in a group. (https://mrctcenter.org/glossaryterm/prevalence/)Prevalence
primary endpointC94496A study measure that is used to answer the main research question. (https://mrctcenter.org/glossaryterm/primary-endpoint/)Primary Endpoint
probabilityC54154The likelihood or chance that something might happen. (https://mrctcenter.org/glossaryterm/probability/)Probability
progression-free survivalC28234The length of time without a person's illness getting worse. (https://mrctcenter.org/glossaryterm/progression-free-survival/)Progression-free Survival
prospective studyC142646Research that uses new data collected from participants. (https://mrctcenter.org/glossaryterm/prospective-study/)Prospective Study
protocolC142451A complete description of the research plan and procedures. (https://mrctcenter.org/glossaryterm/protocol/)Clinical Trial Protocol
proxyC119264A person who is legally allowed to make research decisions for someone else. (https://mrctcenter.org/glossaryterm/proxy/)Proxy
pseudonymizeC203926Replace personal details with a code so that data are protected. (https://mrctcenter.org/glossaryterm/pseudonymized/)Pseudonymize
Quality of Life (QOL)C17047How someone feels and functions day to day. (https://mrctcenter.org/glossaryterm/quality-of-life-qol/)Quality of Life
questionnaireC17048A list of questions for study participants to answer as part of the study. (https://mrctcenter.org/glossaryterm/questionnaire/)Questionnaire
randomizationC25196A way to use chance to place study participants into different study treatment groups. (https://mrctcenter.org/glossaryterm/randomization/)Randomization
randomized controlled trialC46079Research 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
Real World Data (RWD)C165830Health-related information collected from many different types of records and used for research purposes. (https://mrctcenter.org/glossaryterm/real-world-data-rwd/)Real-world Data
Real World Evidence (RWE)C165831Findings from analyzing real world data. (https://mrctcenter.org/glossaryterm/real-world-evidence-rwe/)Real-world Evidence
registry (study)C93453An organized list of research information. (https://mrctcenter.org/glossaryterm/registry-study/)Study Registry
relative riskC93152The chance of a harmful event happening in one study group compared to another. (https://mrctcenter.org/glossaryterm/relative-risk/)Relative Risk
results (study)C203930Findings from the study. (https://mrctcenter.org/glossaryterm/results-study/)Study Results
retrospective studyC53312Research that uses already existing data. (https://mrctcenter.org/glossaryterm/retrospective-study/)Retrospective Study
risk-benefit ratioC203928A 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
risks of a research studyC142718The possible harms of being in a research study. (https://mrctcenter.org/glossaryterm/risks-of-a-research-study/)Subject Risk
sample sizeC53190The number of participants in a study or study group. (https://mrctcenter.org/glossaryterm/sample-size/)Sample Size
schedule of assessmentsC142678A chart that lists the study activities and when they will happen during a study. (https://mrctcenter.org/glossaryterm/schedule-of-assessments/)Schedule Of Assessments
screeningC48262Tests and questions to find out if a person can join a study. (https://mrctcenter.org/glossaryterm/screening/)Trial Screening
secondary endpointC139173A 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
sensitivity (medical test)C41394How well a medical test can accurately identify people who have a disease or trait. (https://mrctcenter.org/glossaryterm/sensitivity-medical-test/)Diagnostic Sensitivity
side effectC2861A health change that is not the intended effect of the treatment and usually considered a problem. (https://mrctcenter.org/glossaryterm/side-effect/)Side Effect
single-blind studyC28233A 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
specificity (medical test)C41395How 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
sponsorC70793The group that is in charge of, or pays for, a research study. (https://dev.mrctcenter.org/glossaryterm/sponsor-3/)Clinical Study Sponsor
standard of careC94396The usual treatment given to patients for an illness. (https://mrctcenter.org/glossaryterm/standard-of-care/)Best Practice
statistically significantC61040Results that are very unlikely to have occurred by chance. (https://mrctcenter.org/glossaryterm/statistically-significant/)Statistical Significance
study designC15320The way a study is set up to answer the study question. (https://mrctcenter.org/glossaryterm/study-design/)Study Design
study interventionC25218A treatment given to the participants in a study. (https://mrctcenter.org/glossaryterm/study-intervention/)Intervention or Procedure
study life cycleC203929The steps of a research study from beginning to end. (https://mrctcenter.org/glossaryterm/study-life-cycle/)Study Life Cycle
study participantC142710A person who joins a research study. (https://mrctcenter.org/glossaryterm/study-participant/)Study Participant
study populationC70833All the participants in a study. (https://mrctcenter.org/glossaryterm/study-population/)Study Population
study statisticianC142737A person who uses math to help design a study and interpret the data. (https://mrctcenter.org/glossaryterm/study-statistician/)Trial Statistician
substudyC198230A study with a smaller group of participants already enrolled in the main study. (https://mrctcenter.org/glossaryterm/substudy/)Substudy
superiority trialC142722A study to test if a study treatment works better than another treatment for the same condition. (https://mrctcenter.org/glossaryterm/superiority-trial/)Superiority Trial
synergistic effectC203931When two or more things used together have a greater effect than each thing alone. (https://mrctcenter.org/glossaryterm/synergistic-effect/)Synergistic Effect
treatment effectC38032How much a study treatment changes a condition, symptom, or function. (https://mrctcenter.org/glossaryterm/treatment-effect/)Therapeutic Effect
umbrella trialC165842A research study that tests and compares two or more study treatments for one disease or condition. (https://mrctcenter.org/glossaryterm/umbrella-trial/)Umbrella Protocol
voluntary participationC203933Choosing to participate in research without feeling pressured. (https://mrctcenter.org/glossaryterm/voluntary-participation/)Voluntary Participation
wash-outC42872A time before starting a study treatment when a person stops taking other medicines. (https://mrctcenter.org/glossaryterm/wash-out/)Washout Period
withdrawC49634To stop being a participant in a study. (https://mrctcenter.org/glossaryterm/withdraw/)Withdrawal by Subject
X-rayC38101A 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
Back to top