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SDTM IG SDTM IG -- Then and Then and NowNow
Updates from version 3.1.2 to 3.1.3Updates from version 3.1.2 to 3.1.3
Presented at DCDISC 25Presented at DCDISC 25--JulJul--20132013
ChangesChanges
New Variables for Human Trials and New Variables for Human Trials and SENDSEND
Incorporation of Amendment 1 Incorporation of Amendment 1
Changes to Trial DesignChanges to Trial Design
Other ChangesOther Changes
Oncology DomainsOncology Domains
SDTM Oncology SubSDTM Oncology Sub--team Activitiesteam Activities
New Variables : DMNew Variables : DM
RFXSTDTCRFXSTDTC Date/Time Date/Time of 1st Study of 1st Study TrtTrt (exp)(exp)
RFXENDTCRFXENDTC Date/Time Date/Time of Last Study of Last Study TrtTrt (exp)(exp)
RFICDTCRFICDTC Date/Time of Date/Time of Informed Consent Informed Consent (exp)(exp)
RFPENDTCRFPENDTC Date/Time Date/Time of End Participation of End Participation (exp)(exp)
DTHDTCDTHDTC Date/Time of Date/Time of Death Death (exp)(exp)
DTHFLDTHFL Subject Death Subject Death Flag Flag (exp)(exp)
AGETXTAGETXT Age Age RangeTextRangeText
SPECIESSPECIES SpeciesSpecies
STRAINSTRAIN Strain/Strain/SubstrainSubstrain
SBSTRAINSBSTRAIN Strain/Strain/SubstrainSubstrain DetailsDetails
ACTARMCDACTARMCD Actual Arm Actual Arm Code Code ((reqreq))
ACTARMACTARM Description of Description of Actual Arm Actual Arm ((reqreq))
SETCDSETCD Set CodeSet Code
Code List for Code List for ACTARMCD/ACTARMACTARMCD/ACTARM
SCRNFAIL / 'Screen Failure' = Screen SCRNFAIL / 'Screen Failure' = Screen failuresfailures
NOTASSGN / 'Not Assigned' = Subjects NOTASSGN / 'Not Assigned' = Subjects not assigned to treatmentnot assigned to treatment
UNPLAN / 'Unplanned Treatment' = Arm UNPLAN / 'Unplanned Treatment' = Arm is not planned (not in Trial Arms)is not planned (not in Trial Arms)
NOTTRT / 'Not Treated' = Randomized NOTTRT / 'Not Treated' = Randomized subjects who were not treatedsubjects who were not treated
New Variables : EventsNew Variables : Events
----LLTCDLLTCD Lowest Level Lowest Level Term Code Term Code (exp)(exp)
----PTCDPTCD Preferred Term Preferred Term Code Code (exp)(exp)
----HLTHLT High Level Term High Level Term (exp)(exp)
----HLTCDHLTCD High Level High Level Term Code Term Code (exp)(exp)
----HLGTHLGT High Level High Level Group Term Group Term (exp)(exp)
----HLGTCDHLGTCD High Level High Level Group Term Code Group Term Code (exp)(exp)
----BDSYCDBDSYCD Body System Body System or Organ Class Code or Organ Class Code (exp)(exp)
----SOCSOC Primary System Primary System Organ Class Organ Class (exp)(exp)
----SOCCDSOCCD Primary Primary System Organ Class System Organ Class Code Code (exp)(exp)
New Variables : FindingsNew Variables : Findings
----ANTREGANTREG Anatomical Anatomical RegionRegion
----SPCUFLSPCUFL Specimen Specimen Usability for the TestUsability for the Test
----LATLAT LateralityLaterality
----DIRDIR DirectionalityDirectionality
----PORTOTPORTOT Distribution Distribution (Portion or Totality)(Portion or Totality)
----LEADLEAD Lead Identified Lead Identified to Collect Measurementsto Collect Measurements
----CSTATECSTATE Consciousness StateConsciousness State
----EVALIDEVALID Evaluator Evaluator SpecifiedSpecified
----ACPTFLACPTFL Accepted Accepted Record FlagRecord Flag
----EXCLFLEXCLFL Exclude from Exclude from StatisticsStatistics
----REASEXREASEX Reason for Reason for Exclusion from StatisticsExclusion from Statistics
----DTHRELDTHREL Related to Related to DeathDeath
New Variables : Timing New Variables : Timing and Identifiersand Identifiers
----DETECTDETECT Time in Time in Days to Detection of Days to Detection of a condition/pathogen a condition/pathogen
POOLIDPOOLID Pool Pool Identifier Identifier
----LNKIDLNKID Link ID Link ID
----LNKGRPLNKGRP Link Link Group IDGroup ID
New Variables : Trial New Variables : Trial SummarySummary
TSVALNFTSVALNF Parameter Null FlavorParameter Null Flavor
TSVALCDTSVALCD Parameter Value CodeParameter Value Code
TSVCDREFTSVCDREF Name of the Reference Name of the Reference TerminologyTerminology
TSVCDVERTSVCDVER Version of the Reference Version of the Reference TerminologyTerminology
Amendment 1 ChangesAmendment 1 Changes
MedDRAMedDRA Terms added to EventsTerms added to Events
----TRTEM (Treatment Emergent Flag) not TRTEM (Treatment Emergent Flag) not includedincluded
New DM variables addedNew DM variables added
Changes to Trial DesignChanges to Trial Design
New variables for TSNew variables for TS
Addition of NULL FLAVOR for TSAddition of NULL FLAVOR for TS
New Codes for TSNew Codes for TS
TS: Trial SummaryTS: Trial Summary
TS: Trial SummaryTS: Trial Summary
TS: Null FlavorTS: Null Flavor
Embodied in the ISO 21090 standard, Embodied in the ISO 21090 standard, ““Health Informatics Health Informatics –– Harmonized data Harmonized data types for information exchange types for information exchange
An ancillary piece of data that provides An ancillary piece of data that provides additional information when its primary additional information when its primary piece of data is null (has a missing value)piece of data is null (has a missing value)
Uses Controlled TerminologyUses Controlled Terminology
Test for future use in other domainsTest for future use in other domains
TS: Null FlavorTS: Null Flavor
No informationNo information
InvalidInvalid
OtherOther
Positive infinityPositive infinity
Negative infinityNegative infinity
UnencodedUnencoded
DerivedDerived
UnknownUnknown
Asked but unknownAsked but unknown
Temporarily unavailableTemporarily unavailable
Not askedNot asked
Quantity sufficientQuantity sufficient
TraceTrace
MaskedMasked
Not applicableNot applicable
TS: Null FlavorTS: Null Flavor
TS: Null FlavorTS: Null Flavor
TSVALNF contains a TSVALNF contains a ““null flavor,null flavor,”” a value that a value that provides additional coded information when provides additional coded information when TSVAL is null. TSVAL is null.
TSPARM = MAXAGE, there is no value if a TSPARM = MAXAGE, there is no value if a study does not specify a maximum age. In this study does not specify a maximum age. In this case, the appropriate null flavor is PINF, which case, the appropriate null flavor is PINF, which stands for positive infinity.stands for positive infinity.
For a drug which indications are not yet For a drug which indications are not yet established, the appropriate null flavor for established, the appropriate null flavor for TINDC would be NA, which stands for not TINDC would be NA, which stands for not applicable.applicable.
TS: Null FlavorTS: Null Flavor
Other: Variable LengthsOther: Variable Lengths
Maximum character length 200Maximum character length 200
Maximum flag length 1Maximum flag length 1
----TESTCD and IDVAR maximum length TESTCD and IDVAR maximum length is 8is 8
Maximum length of variables with control Maximum length of variables with control terminology is length of longest termterminology is length of longest term
Other: AE/MH CodingOther: AE/MH Coding
----DECOD = Preferred TermDECOD = Preferred Term
----BODSYS = SOC used in primary BODSYS = SOC used in primary analysisanalysis
----SOC = Dictionary defined primary SOCSOC = Dictionary defined primary SOC
If If MedDRAMedDRA used, provide all intermediate used, provide all intermediate levelslevels
Other: CM CodingOther: CM Coding
CMDECOD = DrugCMDECOD = Drug’’s generic names generic name
CMCLAS = DrugCMCLAS = Drug’’s class used for s class used for analysis and reportinganalysis and reporting
Additional coding dictionary qualifiers go Additional coding dictionary qualifiers go to SUPPQUAL (e.g. ACT Codes)to SUPPQUAL (e.g. ACT Codes)
Oncology DomainsOncology Domains
TU TU –– Tumor IdentificationTumor Identification
TR TR –– Tumor ResultsTumor Results
RS RS –– Disease ResultsDisease Results
Originally developed based RECIST Originally developed based RECIST criteria criteria
SDTM Oncology SubSDTM Oncology Sub--Team working to Team working to expand usageexpand usage
Oncology DomainsOncology Domains
TU TU –– Tumor IdentificationTumor Identification
Used to uniquely identify tumors, classify Used to uniquely identify tumors, classify them, identify location, how/who identified them, identify location, how/who identified themthem
Per RECIST:Per RECIST:
TargetTarget
NonNon--TargetTarget
New TumorNew Tumor
Handles new, splits and mergesHandles new, splits and merges
Uses Uses ----LNKID to identify and relate tumorsLNKID to identify and relate tumors
TUMIDENT Control TUMIDENT Control TerminologyTerminology
TUTESTCD Control TUTESTCD Control TerminologyTerminology
Oncology DomainsOncology Domains
TR TR –– Tumor ResultsTumor Results
Contains quantitative measurements / Contains quantitative measurements / qualitative assessments of tumors in TUqualitative assessments of tumors in TU
TRTESTCD/TRTEST TRTESTCD/TRTEST –– uses Control uses Control Terminology Terminology –– no derivations by sponsorno derivations by sponsor
If too small If too small –– use criteria lower limit (5mm)use criteria lower limit (5mm)
TRACPTFL TRACPTFL –– only used if multiple only used if multiple evaluatorsevaluators
User TREVALID/TREVAL to identify User TREVALID/TREVAL to identify evaluatorsevaluators
TRTESTCD Control TRTESTCD Control TerminologyTerminology
Oncology DomainsOncology Domains
RS RS –– Disease ResultsDisease Results
Contains response evaluations as Contains response evaluations as determined from results in TRdetermined from results in TR
Use Use ----LNKGRP to link with TR domainLNKGRP to link with TR domain
RSTESTCD/RSTEST RSTESTCD/RSTEST –– uses Control uses Control Terminology Terminology –– no derivations by sponsorno derivations by sponsor
RSCAT RSCAT –– identifies criteria/CLINICAL identifies criteria/CLINICAL ASSESSMENTASSESSMENT
RSACPTFL RSACPTFL –– only used if multiple only used if multiple evaluatorsevaluators
User RSEVALID/RSEVAL to identify User RSEVALID/RSEVAL to identify evaluatorsevaluators
RSTESTCD Control RSTESTCD Control TerminologyTerminology
RSSTRESC Control RSSTRESC Control TerminologyTerminology
TU ExampleTU Example
TR ExampleTR Example
TU Example TU Example (split/merge/new)(split/merge/new)
TR Example TR Example (split/merge/new)(split/merge/new)
RS ExampleRS Example
RELREC ExampleRELREC Example
SDTM Oncology SubSDTM Oncology Sub--team team ActivitiesActivities
Control Terminology UpdatesControl Terminology Updates
Response versus RemissionResponse versus Remission
New New TRTESTsTRTESTs
Collect Response Criteria (90+)Collect Response Criteria (90+)
MO vs. TR for Liver/Spleen MeasurementsMO vs. TR for Liver/Spleen Measurements
RU for Assessments w/o TargetsRU for Assessments w/o Targets
End of Study/End of Study/TrtTrt using DSSCAT using DSSCAT (death as outcome)(death as outcome)
Review CV Usage of TU/TRReview CV Usage of TU/TR