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