OCI Term Compilation (Jennifer)

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source draft category term / definition
CDISCglossary unscheduled adverse event (AE). Synonyms: side effect, adverse experience.
CDISCglossary role analysis variables.
CDISCglossary document approval letter. An official communication from FDA;allow marketing
CDISCglossary time arm. A planned sequence of elements, typically equivalent to a treatment group. [SDTM]
CDISCglossary protocol audit
CDISCglossary protocol baseline assessment
CDISCglossary document Biologics Licensing Application (BLA). An application to FDA for a license to market
CDISCglossary study design blinded study. A study in which is unaware of the treatment assignment
CDISCglossary data causality assessment. An evaluation performed by a medical professional
CDISCglossary quality clinical benefit.
CDISCglossary data clinical clarification. A query resolution from the sponsor See also self evident change.
CDISCglossary quality clinical efficacy.
CDISCglossary quality clinical significance. Change in a subject’s clinical condition regarded as important whether or not due to the test intervention. criteria for clinical significance should be stated in the protocol.
CDISCglossary data clinical trial information. Data collected in the course of a clinical trial
CDISCglossary document Common Technical Document. A format agreed upon by ICH See also eCTD.
CDISCglossary data confidentiality. Prevention of
CDISCglossary study design confirmatory trial. Phase 3 trial during which the previously revealed are confirmed.
CDISCglossary person role consumer safety officer (CSO). FDA official who coordinates the review
CDISCglossary role control group. The group of subjects
CDISCglossary person role coordinating investigator.
CDISCglossary statistics covariate (prognostic). Factor or condition that influences outcome of a trial.
CDISCglossary document curriculum vitae (cv).
CDISCglossary organization role data and safety monitoring board (DSMB). See data monitoring committee.
CDISCglossary document data clarification form. A form used to query an investigator and collect feedback to resolve questions
CDISCglossary data data integrity. An attribute of data
CDISCglossary data data model. Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use.
CDISCglossary protocol decision rule. Succinct statement of
CDISCglossary data discrepancy. The failure of a datapoint to pass a validation check. NOTE:
CDISCglossary disease. Any deviation from or interruption of the normal structure orfunction of a part, organ, or system of the body as manifested by characteristic symptoms and signs.
CDISCglossary quality dosage form. Physical characteristicsof a drug product, (e.g., tablet,capsule, or solution) that contains adrug substance, generally
CDISCglossary quality dosage strength. 1. Proportion of active substance to excipient, measured in units of volume or concentration. 2.The strength of a drug product. tells how much of the active ingredient is present in each dosage.
CDISCglossary science drug development process. The
CDISCglossary role drug product. 1. A dosage form thatcontains an active drug ingredient orplacebo; 2. A finished dosage form asdescribed in regulations. [SPL Glossary]
CDISCglossary data effect. An effect attributed to a treatment in a clinical trial. In most clinical trials, the treatment effect of interest is a comparison (or contrast) of two or more treatments.
CDISCglossary quality effectiveness. The desired measure of a drug’s influence on a disease or condition as demonstrated by substantial evidence from adequate and well-controlled investigations.
CDISCglossary quality efficacy. The capacity of a drug ortreatment to produce beneficial effects
CDISCglossary time element. 1. In trial design, a basicbuilding block for time within a clinicaltrial comprising the followingcharacteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.
CDISCglossary data endpoint. Variable that pertains tothe efficacy or safety evaluations of a
CDISCglossary aggregate population enrollment (cumulative). Current enrollment as well as any ever-enrolled subjects who have ended participation.
CDISCglossary time epoch. An interval of time in the planned conduct of a study during which the treatment is consistent. Synonyms: period, cycle, phase, stage.
CDISCglossary quality equipoise. A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.
CDISCglossary document eSource document (electronic
CDISCglossary organization role Ethics Committees
CDISCglossary protocol exclusion criteria. List of
CDISCglossary conclusion finding. A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis.
CDISCglossary conclusion global assessment variable. A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator’s overall impression about the state or change in state of asubject.
CDISCglossary hypothesis hypothesis to test. In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesistest, which generates a P value.
CDISCglossary protocol inclusion criteria. The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population.See also exclusion criteria.independent data monitoring
CDISCglossary computer Internet service provider (ISP). A
CDISCglossary quality inter-rater reliability. The property of scales yielding equivalent results when used by different raters ondifferent occasions.
CDISCglossary role intervention. The drug, device, therapy or process under investigationin a clinical trial which has an effect on outcome of interest in a study: e.g.,health-related quality of life, efficacy,safety, pharmacoeconomics. Synonyms:therapeutic intervention, medical product. See also: test articles; devices;
CDISCglossary role investigational product. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
CDISCglossary role investigational treatment. An intervention under investigation in a clinical trial.
CDISCglossary investigator/institution. An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.
CDISCglossary data item definition. 1. In a questionnaire or form to be completed in a clinical trial, the specification of a question and the specification of the format and semantics of the response.2. Formal specification of the properties of an item or field of data in an eClinical trial.
CDISCglossary Janus. 1. A logical design conceivedby Dr. Norman Stockbridge of the FDAfor a data warehouse intended to integrate submission data, protocol descriptions and analysis plans from clinical and animal studies into as an FDA review environment that uses a set of validated, standards-based tools toallow reproducible cross-study, datamining and retrospective comparative analysis. 2) the name assigned to acomponent of the NCI’s CaBIG ClinicalResearch Information Exchange (CRIX)
CDISCglossary time last subject out/complete(LSC/LPC or LSO/LPO). 1. The dateand time when the last subject hasreached a planned or achievedmilestone representing the completionof the trial. 2. The last subject tocomplete a trial. See also subject, pt, completion
CDISCglossary time legal authentication. A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document.
CDISCglossary role medicinal product. Synonym for therapeutic intervention, but usually a drug.
CDISCglossary data model model. A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context, e.g., clinical trial data.
CDISCglossary document Nuremberg Code. Code of ethics,set forth in 1947, for conducting human medical research.objective. The reason for performing a trial in terms of the scientific questions to be answered by the analysis of data collected during the trial. NOTE: The primary objective is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing).
CDISCglossary data objective measurement. A measurement of a physiological or medical variable such as blood glucose level that is obtained by a measuring device rather than a human judgment or assessment. See also outcome, patient-reported outcome;
CDISCglossary time open to enrollment. The status of a study such that a subject can be enrolled into that study.
CDISCglossary standard operational model. The set of CDISC data standards (including ODMand LAB) used to capture and archive data from clinical trials.
CDISCglossary data outcome (of adverse event).Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved,recovering/ resolving, not recovered/notresolved, recovered /resolved with sequelae, fatal, or unknown
CDISCglossary data outcome. 1. Events or experiences that clinicians or investigators examining the impact of an intervention or exposure measure because they believe such events or experiences may be influenced by the intervention or exposure. 2. SDTM; The result of carrying out a mathematical or statistical procedure. NOTE:outcome is more general than endpoint in that it does not necessarily relate to a planned objective
CDISCglossary mixed packaging. The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.
CDISCglossary data patient-reported outcome Patient-reported outcomes are subjective measurements.
CDISCglossary role per-protocol analysis set. The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment according to the underlying scientific model.
CDISCglossary protocol pharmacogenetic test. An assay intended to study inter individual variations in DNA sequence related to drug absorption and disposition or drug action. Compare to pharmacogenomic test.
CDISCglossary study design phase. Clinical trials are generally categorized into four (sometimes five) phases A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases.
CDISCglossary role primary variable. An outcome of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation.NOTE: Differences between groups in the primary and secondary variable(s)are believed to be the result of the group-specific interventions.
CDISCglossary role product. 1. Drug product: A finished dosage form that contains a drug substance. 2. A physical entity that isintended to diagnose, treat, or preventa disease or other abnormal condition,and subject to regulatory authority
CDISCglossary protocol protocol approval (Sponsor).Sponsor action at the completion of protocol development that is marked when the signature of the last reviewer on the protocol approval form has been obtained, signifying that all reviewer changes to the protocol have been incorporated
CDISCglossary unscheduled protocol violation. A significant departure from processes or procedures that were required by the protocol.Violations often result in data that are not deemed evaluable for a per protocol analyis, and may require that the subject(s) who violate the protocol
CDISCglossary person role proxy respondent. Someone other than the patient who is responding about the patient on behalf of the patient, not as an observer. Compare to observer assessment.
CDISCglossary statistics qualitative variable. One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categoriesaccording to their attributes.
CDISCglossary quality quality of life. A broad ranging concept that incorporates an individual’s physical health, psychological state, level of independence, social relationships,personal beliefs and their relationships to salient features of the environment.
CDISCglossary document query. A request for clarification on a data item collected for a clinical trial;specifically a request from a sponsor or sponsor’s representative to an investigator to resolve an error or inconsistency discovered during data review.
CDISCglossary statistics random number table.
CDISCglossary statistics random sample. Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.randomization. The process of assigning trial subjects to treatment or
CDISCglossary data raw data. Data as originally collected.Distinct from derived. Raw data includes records of original observations, measurements, and activities (such as laboratory notes,evaluations, data recorded by automated instruments)
CDISCglossary time recruitment period. Time period during which subjects are or are planned to be enrolled in a clinical trial.
CDISCglossary data model Reference Information Model(RIM). An information model used as the ultimate defining reference for al lHL7 standards.
CDISCglossary data registry. A data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.
CDISCglossary quality reliability, psychometric. The degree to which a psychometric “instrument” is free from random error either by testing the homogeneity of content on multi-item tests with internal consistency evaluation or testing the degree to which the instrument yields stable scores over time
CDISCglossary hypothesis research hypothesis. The proposition that a study sets out to support (or disprove); for example,“blood pressure will be lowered by[specific endpoint] in subjects who receive the test product.” See also null hypothesis.
CDISCglossary data Researcher’s records of subjects/patients, such as patient medical charts, hospital records, X-rays,and attending physician’s notes. NOTE:These records may or may not accompany an application to a Regulatory Authority, but must be kept
CDISCglossary quality risk. In clinical trials, the probability of harm or discomfort for subjects. NOTE:Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat,for example, will be expected to have a low incidence of troubling side effects.
CDISCglossary quality safety and tolerability. The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs andsymptoms), and other special safetytests (e.g., ECGs, ophthalmology). The tolerability of the medical productrepresents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]
CDISCglossary quality safety. Relative freedom from harm.In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests andprocedures, psychiatric evaluation,
CDISCglossary semantic. In the context of a technical specification, semantic refers to the meaning of an element asdistinct from its syntax. Syntax canchange without affecting semantics.
CDISCglossary study design single-blind study. A study in which one party, either the investigatoror the subject, does not know which medication or placebo is administered to the subject; also called single masked study. See also blind study,double-blind study, triple-blind study.
CDISCglossary data source data. All information in original records and certified copies of original records of clinical findings,observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
FCR 1. Basic vs applied
FCR 1. Hierarchical – show vertical relationships
FCR quality 1. Morbidity
FCR data 1. Outcome assessment
FCR 1. Physical
FCR protocol 1. Tradition (precedent)
FCR study design 10. Historical research
FCR quality 10. self-assessment of functional capacity
FCR role 10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
FCR 11. Propositions – state the relationships between variables
FCR quality 11. quality of life
FCR study design 11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
FCR data model 12. Model – symbolic representation of the elements of a system
FCR study design 12. Single-subject design
FCR conclusion 13. Inductive theory – theory based on empirically verifiable observations
FCR study design 13. Sequential clinical trial
FCR study design 14. Evaluation research – assessment of the success of a program or policy
FCR conclusion 14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
FCR conclusion 15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
FCR study design 15. Quasi-experimental research
FCR protocol 16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
FCR study design 16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
FCR protocol 17. Deduction – theory testing
FCR study design 17. Qualitative vs quantitative research
FCR protocol 18. Induction – theory development
FCR data 2. Acute conditions and chronic conditions
FCR protocol 2. Authority (trusted expert)
FCR quality 2. mortality
FCR study design 2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
FCR 2. Schematic
FCR time 2. Temporal – order concepts in time and states a sequence of events
FCR study design 3. Case study – description of one or more patients
FCR data 3. length of stay
FCR 3. Process
FCR time 3. Quantitative – frequency or duration of a specific behavior
FCR data 3. Sources of knowledge
FCR protocol 3. Trial and error
FCR study design 4. Developmental research – description of pattern of change over time
FCR protocol 4. Logical reasoning - Deductive reasoning, Inductive reasoning
FCR data 4. readmission
FCR 4. Statistical
FCR science 4. Types of research
FCR study design 5. Normative research – establishing normal values
FCR quality 5. Physical
FCR protocol 5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
FCR study design 6. Qualitative research – gathering data through interview or observation
FCR quality 6. social
FCR data model 6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
FCR study design 7. Cohort or case-control studies – establish associations
FCR hypothesis 7. Hypothesis - specific predictions based on a theory.
FCR quality 7. psychological well-being
FCR data 8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
FCR study design 8. Methodological studies – establish reliability and validity of a new method
FCR quality 8. Patient satisfaction
FCR data 9. Constructs – concepts that represent non-observable behaviors or events
FCR quality 9. patient preference
FCR study design 9. Secondary analysis – exploring new relationships in old data
MUSC data accrual rate
MUSC role active control
MUSC adherence
MUSC unscheduled adjustment
MUSC unscheduled adverse event
MUSC data allocation ratio
MUSC statistics alternative hypothesis
MUSC data analysis datasets
MUSC protocol assessment
MUSC statistics assessment bias
MUSC time assessment schedule
MUSC as-treated
MUSC protocol auditing
MUSC study design balanced design
MUSC baseline
MUSC baseline comparability
MUSC statistics bias
MUSC protocol biased coin randomizaiton
MUSC statistics binormial
MUSC quality bioequivalence
MUSC protocol blinding
MUSC role block
MUSC data carryover effect
MUSC document case report
MUSC document case report form
MUSC study design case-control design
MUSC protocol censoring
MUSC data clinical trial management system
MUSC protocol cluster randomization
MUSC protocol coding
MUSC role cohort
MUSC study design community intervention trial
MUSC quality comparative treatment efficacy
MUSC quality complaince
MUSC role concurrent controls
MUSC statistics confidence interval
MUSC study design confirmatory trial
MUSC role confounder
MUSC role confounding factor
MUSC document CONSORT statement
MUSC constrain
MUSC context
MUSC data continous
MUSC role controls
MUSC study design crossover
MUSC study design crossover trial
MUSC cross-sectional analysis
MUSC organization role data and safety monitoring board
MUSC document data clarification query
MUSC document data clarification request
MUSC time data collection schedule
MUSC protocol data management
MUSC protocol data management plan
MUSC organization role data safety monitoring committee
MUSC data database
MUSC protocol data-dependent stopping
MUSC data derived data
MUSC deterministic
MUSC study design diagnostic trial
MUSC dichotomous
MUSC data discret
MUSC conclusion dose finding
MUSC protocol double blinding
MUSC protocol double masking
MUSC unscheduled dropouts
MUSC quality drug lot
MUSC unscheduled early termination
MUSC quality efficacy
MUSC protocol electronic data capture
MUSC protocol eligibility
MUSC data endpoint
MUSC quality equipoise
MUSC study design equivalence trials
MUSC protocol estimate
MUSC protocol evaluation
MUSC organization role excecutive committee
MUSC protocol exclusion criteria
MUSC expectation bias
MUSC experiment
MUSC study design factorial design
MUSC protocol follow-up
MUSC group sequential
MUSC role historic controls
MUSC statistics imbalance
MUSC protocol imputation of missing data
MUSC protocol inclusion criteria
MUSC protocol informed consent
MUSC organization role institutional review board
MUSC protocol intention to treat
MUSC role intention to treat population
MUSC statistics interaction
MUSC protocol interim analysis
MUSC intersubject
MUSC role intervention
MUSC intrasubject
MUSC document investigational new drug (IND) application
MUSC quality investigator competence
MUSC local control
MUSC data lost to follow-up
MUSC statistics main effect
MUSC protocol masking
MUSC person role medical safety monitor
MUSC protocol meta-analysis
MUSC protocol minimization randomization
MUSC minority representation
MUSC data missing data
MUSC protocol monitoring
MUSC study design multi-center
MUSC study design multi-site
MUSC statistics multivariable
MUSC conclusion negative findings
MUSC statistics nesting design
MUSC document new drug application (NDA)
MUSC statistics Neyman allocation
MUSC unscheduled nonadherence
MUSC unscheduled noncomplaince
MUSC noninferiority
MUSC statistics null hypothesis
MUSC data observation
MUSC statistics odds
MUSC statistics odds ratio
MUSC statistics one-sided test
MUSC optimal allocation
MUSC quality over-the -count (OTC)
MUSC study design parallel design
MUSC protocol permuted block randomization
MUSC role per-protocol population
MUSC study design phase I trial
MUSC study design phase II trial
MUSC study design phase IIA
MUSC study design phase IIB
MUSC study design phase IIB
MUSC study design phase III trial
MUSC study design phase IV trial
MUSC study design pivotal trials
MUSC study design placebo controlled
MUSC protocol play the winner
MUSC role plecabo
MUSC aggregate population
MUSC conclusion positive findings
MUSC statistics power
MUSC study design prevention trials
MUSC primary efficacy
MUSC conclusion primary outcome
MUSC data primary response
MUSC person role principal investigator
MUSC role prognostic factor
MUSC protocol project management
MUSC protocol project management plan
MUSC protocol protocal complaince
MUSC protocol protocol
MUSC unscheduled protocol exception
MUSC unscheduled protocol violation
MUSC statistics pseudorandom
MUSC statistics p-value
MUSC protocol quality assurance
MUSC protocol random play the winner
MUSC protocol recruitment
MUSC protocol regulatory management
MUSC data repeat measurement
MUSC data response
MUSC protocol response adaptive randomization
MUSC study design retrospective design
MUSC quality safety
MUSC statistics sample size
MUSC sample size inflation
MUSC protocol screening
MUSC selection bias
MUSC study design sequential design
MUSC unscheduled serious adverse event
MUSC role sham treatment
MUSC study design single-center
MUSC study design single-site
MUSC document source document
MUSC person role sponsor
MUSC protocol statistical analysis plan
MUSC statistics statistical significant
MUSC organization role steering committee
MUSC protocol stop rule
MUSC statistics stratification
MUSC person role study coordinator
MUSC role subject
MUSC quality superiority
MUSC conclusion surrogate outcome
MUSC time time to event
MUSC protocol titration
MUSC quality tocxicity
MUSC quality tolerability
MUSC role treatment
MUSC treatment allocation
MUSC role treatment group
MUSC unscheduled treatment-emergenet adverse event (TEAE)
MUSC protocol trilple blinding
MUSC protocol triple masking
MUSC statistics two-sided test
MUSC statistics type I error
MUSC statistics type II error
MUSC statistics univariable
MUSC protocol urn randomization
MUSC varibility
MUSC time washout period
MUSC protocol withdrawal consent
RCT role Analyzed population
RCT time Anchored-time
RCT conclusion Ancillary-outcome
RCT data Baseline
RCT protocol Blinding
RCT protocol Blinding-method
RCT study design Cointervention*
RCT study design Comparison-arm
RCT quality Cost
RCT role Crossover population
RCT time Date
RCT Device
RCT time Double-anchored-interval
RCT role Drug
RCT protocol Drug-step
RCT time Duration
RCT role Eligible-population
RCT role Enrolled-population
RCT role Excluded population
RCT protocol Exclusion-rule
RCT protocol Executed-protocol
RCT protocol Executed-secondary-study-protocol
RCT study design Experimental-arm
RCT protocol Follow-up activity
RCT role Funder
RCT protocol Inclusion-rule
RCT organization Institution
RCT protocol Intended-protocol
RCT protocol Intended-secondary-study-protocol
RCT time Interval
RCT study design Intervention*
RCT study design Intervention-arm
RCT protocol Intervention-step
RCT role Investigator
RCT protocol Non-drug-intervention-step
RCT No-treatment
RCT data Outcome
RCT data Outcomes-followup
RCT role Placebo
RCT conclusion Primary-outcome
RCT protocol Primary-recruitment-flowchart
RCT protocol Procedure
RCT protocol Protocol
RCT unscheduled Protocol-change
RCT protocol Protocol-concept
RCT role Randomized-population
RCT Reason
RCT role Recruited-population
RCT protocol Recruitment-flowchart
RCT role Screened-population
RCT conclusion Secondary-outcome
RCT study design Secondary-study
RCT protocol Secondary-study-protocol
RCT data Side-effect
RCT time Single-anchored-interval
RCT role Site-enrollment
RCT protocol Stopping-rule
RCT role Study-arm population
RCT organization role Study-committee
RCT conclusion Study-outcome
RCT organization role Study-site
RCT time Timepoint
RCT time Time-range
RCT role Treatment-assignment
RCT Trial
RCT role Trial-participant
RCT data Withdrawal-reason
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