SDTM IG - Then and Now

Transcription

1 SDTM IG - Then and Now Updates from version to Presented at DCDISC 25-Jul Jul-2013

2 Changes New Variables for Human Trials and SEND Incorporation of Amendment 1 Changes to Trial Design Other Changes Oncology Domains SDTM Oncology Sub-team Activities

3 New Variables : DM RFXSTDTC Date/Time of 1st Study Trt (exp) RFXENDTC Date/Time of Last Study Trt (exp) RFICDTC Date/Time of Informed Consent (exp) RFPENDTC Date/Time of End Participation (exp) DTHDTC Date/Time of Death (exp) DTHFL Subject Death Flag (exp) AGETXT Age RangeText SPECIES Species STRAIN Strain/Substrain Substrain SBSTRAIN Strain/Substrain Substrain Details ACTARMCD Actual Arm Code (req req) ACTARM Description of Actual Arm (req req) SETCD Set Code

4 Code List for ACTARMCD/ACTARM SCRNFAIL / 'Screen Failure' = Screen failures NOTASSGN / 'Not Assigned' = Subjects not assigned to treatment UNPLAN / 'Unplanned Treatment' = Arm is not planned (not in Trial Arms) NOTTRT / 'Not Treated' = Randomized subjects who were not treated

5 New Variables : Events --LLTCD Lowest Level Term Code (exp) --PTCD Preferred Term Code (exp) --HLT High Level Term (exp) --HLTCD High Level Term Code (exp) --HLGT High Level Group Term (exp) --HLGTCD High Level Group Term Code (exp) --BDSYCD Body System or Organ Class Code (exp) --SOC Primary System Organ Class (exp) --SOCCD Primary System Organ Class Code (exp)

6 New Variables : Findings --ANTREG Anatomical Region --SPCUFL Specimen Usability for the Test --LAT Laterality --DIR Directionality --PORTOT Distribution (Portion or Totality) --LEAD Lead Identified to Collect Measurements --CSTATE Consciousness State --EVALID Evaluator Specified --ACPTFL Accepted Record Flag --EXCLFL Exclude from Statistics --REASEX Reason for Exclusion from Statistics --DTHREL Related to Death

7 New Variables : Timing and Identifiers --DETECT Time in Days to Detection of a condition/pathogen POOLID Pool Identifier --LNKID Link ID --LNKGRP Link Group ID

8 New Variables : Trial Summary TSVALNF Parameter Null Flavor TSVALCD Parameter Value Code TSVCDREF Name of the Reference Terminology TSVCDVER Version of the Reference Terminology

9 Amendment 1 Changes MedDRA Terms added to Events --TRTEM (Treatment Emergent Flag) not included New DM variables added

10 Changes to Trial Design New variables for TS Addition of NULL FLAVOR for TS New Codes for TS

11 TS: Trial Summary

12 TS: Trial Summary

13 TS: Null Flavor Embodied in the ISO standard, Health Informatics Harmonized data types for information exchange An ancillary piece of data that provides additional information when its primary piece of data is null (has a missing value) Uses Controlled Terminology Test for future use in other domains

14 TS: Null Flavor No information Invalid Other Positive infinity Negative infinity Unencoded Derived Unknown Asked but unknown Temporarily unavailable Not asked Quantity sufficient Trace Masked Not applicable

15 TS: Null Flavor

16 TS: Null Flavor TSVALNF contains a null flavor, a value that provides additional coded information when TSVAL is null. TSPARM = MAXAGE, there is no value if a study does not specify a maximum age. In this case, the appropriate null flavor is PINF, which stands for positive infinity. For a drug which indications are not yet established, the appropriate null flavor for TINDC would be NA, which stands for not applicable.

17 TS: Null Flavor

18 Other: Variable Lengths Maximum character length 200 Maximum flag length 1 --TESTCD and IDVAR maximum length is 8 Maximum length of variables with control terminology is length of longest term

19 Other: AE/MH Coding --DECOD = Preferred Term --BODSYS = SOC used in primary analysis --SOC = Dictionary defined primary SOC If MedDRA used, provide all intermediate levels

20 Other: CM Coding CMDECOD = Drug s s generic name CMCLAS = Drug s s class used for analysis and reporting Additional coding dictionary qualifiers go to SUPPQUAL (e.g. ACT Codes)

21 Oncology Domains TU Tumor Identification TR Tumor Results RS Disease Results Originally developed based RECIST criteria SDTM Oncology Sub-Team working to expand usage

22 Oncology Domains TU Tumor Identification Used to uniquely identify tumors, classify them, identify location, how/who identified them Per RECIST: Target Non-Target New Tumor Handles new, splits and merges Uses --LNKID to identify and relate tumors

23 TUMIDENT Control Terminology

24 TUTESTCD Control Terminology

25 Oncology Domains TR Tumor Results Contains quantitative measurements / qualitative assessments of tumors in TU TRTESTCD/TRTEST uses Control Terminology no derivations by sponsor If too small use criteria lower limit (5mm) TRACPTFL only used if multiple evaluators User TREVALID/TREVAL to identify evaluators

26 TRTESTCD Control Terminology

27 Oncology Domains RS Disease Results Contains response evaluations as determined from results in TR Use --LNKGRP to link with TR domain RSTESTCD/RSTEST uses Control Terminology no derivations by sponsor RSCAT identifies criteria/clinical ASSESSMENT RSACPTFL only used if multiple evaluators User RSEVALID/RSEVAL to identify evaluators

28 RSTESTCD Control Terminology

29 RSSTRESC Control Terminology

30 TU Example

31 TR Example

32 TU Example (split/merge/new)

33 TR Example (split/merge/new)

34 RS Example

35 RELREC Example

36 SDTM Oncology Sub-team Activities Control Terminology Updates Response versus Remission New TRTESTs Collect Response Criteria (90+) MO vs. TR for Liver/Spleen Measurements RU for Assessments w/o Targets End of Study/Trt using DSSCAT (death as outcome) Review CV Usage of TU/TR