CDISC ADaM Controlled Terminology

CDISC ADaM Controlled Terminology, 2017-03-31
Legend:
CodeList
CodeListItem
NCI attributes
C117745Analysis Purpose
C117744Analysis Reason
C81223Date Imputation Flag
C81224Derivation Type
C81225Parameter Type
C124296Subject Trial Status
C81226Time Imputation Flag

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C117745.ANLPURPAnalysis Purpose
(ANLPURP)
text
Extensible: Yes
C117745Analysis PurposePurpose of a specific analysis result described in ADaM analysis results metadata.CDISC ADaM Analysis Purpose Terminology
EXPLORATORY OUTCOME MEASUREC98724Exploratory Outcome MeasureExploratory measures that will be used to evaluate the intervention(s) or, for observational studies, that are exploratory of the study.Exploratory Outcome Measure
PRIMARY OUTCOME MEASUREC98772Primary Outcome MeasureThe primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s).Primary Outcome Measure
SECONDARY OUTCOME MEASUREC98781Secondary Outcome MeasureOther key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s).Secondary Outcome Measure
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CL.C117744.ANLREASAnalysis Reason
(ANLREAS)
text
Extensible: Yes
C117744Analysis ReasonReason for reporting a specific analysis result described in ADaM analysis results metadata.CDISC ADaM Analysis Reason Terminology
DATA DRIVENC117750The analysis was triggered by findings in the data.Data Driven Analysis
REQUESTED BY REGULATORY AGENCYC117751The analysis has been requested by a regulatory agency.Analysis Requested by Regulatory Agency
SPECIFIED IN PROTOCOLC117752The analysis is specified in a protocol.Analysis Specified in Protocol
SPECIFIED IN SAPC117753The analysis is specified in a statistical analysis plan.Analysis Specified in Statistical Analysis Plan
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CL.C81223.DATEFLDate Imputation Flag
(DATEFL)
text
Extensible: No
C81223Date Imputation FlagDate Imputation Flag: Indicates the level of imputation reflected in a date value.CDISC ADaM Date Imputation Flag Terminology
DC81212Day Imputed: Day is imputed.Day Imputed
MC81211Month Imputed: Month and day are imputed.Month Day Imputed
YC81210Year Imputed: Entire date (year, month and day) is imputed.Year Month Day Imputed
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CL.C81224.DTYPEDerivation Type
(DTYPE)
text
Extensible: Yes
C81224Derivation TypeDerivation Type: Analysis value derivation method.CDISC ADaM Derivation Type Terminology
AVERAGEC81209Average: A data derivation technique which calculates a subject's average value over a defined set of records.Average of Value Derivation Technique
BCC92225Best Case: A data imputation technique which populates missing values with the best possible outcome.Best Case Imputation Technique
BLOCFC81201Baseline Observation Carried Forward: A data imputation technique which populates missing values with the subject's nonmissing baseline observation.Baseline Observation Carried Forward Imputation Technique
BOCC132340Best Observed Case: A data imputation technique which populates analysis values with the best outcome recorded within a subject.Best Observed Case Imputation Technique
BOCFC92226Best Observation Carried Forward: A data imputation technique which populates missing values with the subject's previous best-case nonmissing value.Best Observation Carried Forward Imputation Technique
ENDPOINTC82866Endpoint: A data derivation technique which populates a subject's analysis end point value.Endpoint Value Derivation Technique
INTERPC81208Interpolation: A method of imputation involving a missing value that is between known values and is estimated by a function of those known values.Interpolation Imputation Technique
LOCFC81198Last Observation Carried Forward: A data imputation technique which populates missing values with the subject's previous nonmissing value.Last Observation Carried Forward Imputation Technique
LOVC132341Last Observed Value: A data imputation technique which populates analysis values with the subject's last recorded nonmissing observation.Last Observed Value Imputation Technique
LVPDC132342Last Value Prior to Dosing: A data imputation technique which populates missing values with the subject's last observed value prior to the start of study treatment.Last Value Prior to Dosing Imputation Technique
MAXIMUMC82868Maximum: A technique which populates an analysis value with a subject's maximum value over a defined set of records.Maximum Value Derivation Technique
MINIMUMC82867Minimum: A technique which populates an analysis value with a subject's minimum value over a defined set of records.Minimum Value Derivation Technique
MLC53331Maximum Likelihood: A data imputation technique which populates missing values with estimates that maximize the probability of observing what has in fact been observed.Maximum Likelihood Estimation
MOTHC81204Mean of Other Group: A data imputation technique which populates missing values with the mean value from a comparator or reference group.Mean of Other Group Imputation Technique
MOVC81207Mean Observed Value in a Group: A data imputation technique which populates missing values with the mean value observed in a group of subjects.Mean Observed Value in a Group Imputation Technique
POCFC81205Penultimate Observation Carried Forward: A data imputation technique which populates missing values with the subject's next-to-last nonmissing value.Penultimate Observation Carried Forward Imputation Technique
SOCFC81200Screening Observation Carried Forward: A data imputation technique which populates missing values with the subject's nonmissing screening observation.Screening Observation Carried Forward Imputation Technique
WCC81203Worst Case: A data imputation technique which populates analysis values with the worst possible outcome.Worst Case Imputation Technique
WOCC132343Worst Observed Case: A data imputation technique which populates analysis values with the worst recorded outcome within a subject.Worst Observed Case Imputation Technique
WOCFC81199Worst Observed Value Carried Forward: A data imputation technique which populates missing values with the subject's worst-case nonmissing observation.Worst Observation Carried Forward Imputation Technique
WOVC81206Worst Observed Value in a Group: A data imputation technique which populates missing values with the worst value observed in a group of subjects.Worst Observed Value in a Group Imputation Technique
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CL.C81225.PARAMTYPParameter Type
(PARAMTYP)
text
Extensible: No
C81225Parameter TypeParameter Type: Indicates whether the parameter is derived as a function of one or more other parameters.CDISC ADaM Parameter Type Terminology
DERIVEDC81197Derived: Indicates that a parameter is derived as a function of one or more other parameters.Derived Flag
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CL.C124296.SBJTSTATSubject Trial Status
(SBJTSTAT)
text
Extensible: Yes
C124296Subject Trial StatusIndicates the status of the subject in the trial.CDISC ADaM Subject Trial Status Terminology
COMPLETEDC25250To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI)Complete
DISCONTINUEDC25484To stop or end, permanently or temporarily.Discontinue
ONGOINGC53279ContinuousRemain in force or carry on without letup; keep or maintain in unaltered condition; exist in time or space without stop or interruption. (NCI)Continue
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CL.C81226.TIMEFLTime Imputation Flag
(TIMEFL)
text
Extensible: No
C81226Time Imputation FlagTime Imputation Flag: Indicates the level of imputation reflected in a time value.CDISC ADaM Time Imputation Flag Terminology
HC81213Hours Imputed: Entire time (hours, minutes and seconds) is imputed.Hours Minutes Seconds Imputed
MC81214Minutes Imputed: Minutes and seconds are imputed.Minutes Seconds Imputed
SC81215Seconds Imputed: Seconds are imputed.Seconds Imputed
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