1. SUPPQUAL – Where’s My Mommy? Sandra VanPelt Nguyen Midwest CDISC Users Group May 2012

2. Abstract When using CDISC standards, there may be situations in which a field has been collected on a CRF or included in a vendor data transfer which seems to be clinically relevant but is not “topic” data belonging in a standard or custom SDTM domain (any of the three general observation classes). Since non-standard variables cannot be added to SDTM domains, this data typically gets mapped to a SUPPQUAL (Supplemental Qualifiers) dataset, but what do we do when there is not an obvious “parent” record corresponding to this data within one of the SDTM domains? This presentation will provide a set of guidelines to use to determine how best to handle these situations.

3. Discussion Topics ► Introduction/Background ► Guidelines ► Examples © 2011. All rights reserved.3

4. Intro to Supplemental Qualifiers (SUPPQUAL) ► CDISC SDTM organizes data in domains (datasets) based on topic ► Topics are divided amongst 3 general domain classes - Interventions, Events, Findings ► Topics which do not fall into a reserved SDTM domain but fit into a general domain class may go into custom domains ► Variables cannot be added to domains with exception of certain timing, identifier and qualifier variables allowable within the general domain class ► SDTM allows for the inclusion of additional variables using the Supplemental Qualifiers special-purpose domain

5. Intro to Supplemental Qualifiers (SUPPQUAL) ► SUPPQUAL is used to capture non-standard variables and their association to parent records in general observation class datasets or DM (demographics) ► QNAM (qualifier variable name) and QLABEL (qualifier variable label) are used to describe the particular qualifier ► Variables IDVAR (identifying variable) and IDVARVAL (identifying variable value) provide the linkage between records (qualifier child to observation(s) parent) by identifying the variable to join on and the variable value of the specific record(s) which are related ► SUPPQUAL is typically split as SUPP--, with the suffix based on the related domain’s code, e.g. SUPPAE for qualifiers related to the AE domain

6. SUPPQUAL Example © 2011. All rights reserved.6 CMTRTReported Name of Drug, Med, or Therapy CMCATCategory for Medication CMINDCIndication CMDOSEDose per Administration CMDOSTXTDose Description CMDOSUDose Units CMSTDTCStart Date/Time of Medication CMENDTCEnd Date/Time of Medication CMLOCLocation of Dose Administration CMTRT CMSTDTC CMENDTC CMLOC CMDOSE/CMDOSTXT CMDOSU

7. SUPPQUAL Example: Parent-Child Relationship USUBJIDCMSEQCMTRTCMDOSECMDOSUCMLOCCMSTDTCCMENDTC ABC-001-00011PALLIATIVE RADIATION68GyPROSTATE2010-01-202010-03-01 CM: SUPPCM: USUBJIDRDOMAINIDVARIDVARVALQNAMQLABELQVAL ABC-001-0001CMCMSEQ1REASDISCReason for DiscontinuationCompleted therapy

8. SUPPQUAL Example: No Parent USUBJIDCMSEQCMTRTCMDOSECMDOSUCMLOCCMSTDTCCMENDTC ABC-001-00011PALLIATIVE RADIATION68GyPROSTATE2010-01-202010-03-01 ABC-001-00021PALLIATIVE RADIATION72GyPROSTATE2010-11-012010-11-25 CM: SUPPCM: USUBJIDRDOMAINIDVARIDVARVALQNAMQLABELQVAL ABC-001-0001CMCMSEQ2REASDISCReason for DiscontinuationCompleted therapy NO MATCH ON USUBJID, CMSEQ SD0078: Referenced record not found

9. SUPPQUAL Example: No Parent SUPPCM: USUBJIDRDOMAINIDVARIDVARVALQNAMQLABELQVAL ABC-001-0001CMREASDISCReason for DiscontinuationCompleted therapy What to do when you do not know what to use for IDVAR/IDVARVAL?

10. Sample CRF

11. Mapping Guidelines 1. Does the data belong in a general observation class domain? 2. Is there a not-so-obvious parent? 3. Is the data actually needed? 4. Time to get creative

12. Applying the Guidelines – Example 1 (1) Does the data belong in a general observation class domain? (2) Is there a not-so- obvious parent? (3) Is the data actually needed? Time to get creative!

13. Applying the Guidelines – Example 1

14. Applying the Guidelines – Example 2 (1) Does the data belong in a general observation class domain?

15. Applying the Guidelines – Example 2

16. Applying the Guidelines – Example 3 (1) Does the data belong in a general observation class domain? (2) Is there a not-so- obvious parent?

17. Applying the Guidelines – Example 3

18. Applying the Guidelines – Example 4 (2) Is there a not-so- obvious parent? (1) Does the data belong in a general observation class domain?

19. Applying the Guidelines – Example 5 (2) Is there a not-so- obvious parent? (1) Does the data belong in a general observation class domain? (3) Is the data actually needed?

20. Applying the Guidelines – Example 5

21. Applying the Guidelines – Example 6 (3) Is the data actually needed? Time to get creative! (1) Does the data belong in a general observation class domain? (2) Is there a not-so- obvious parent?

22. Applying the Guidelines – Example 6

23. Conclusion ► Be on the lookout for possible “lost children” when annotating and creating mapping specifications. ► Be mindful of the intent and relevance of the data. ► Consider how/if the information will be used for review or analysis. ► Determine the best fit within the SDTM standard.

24. © 2011. All rights reserved. 24 Thank you Sandra VanPelt Nguyen svanpeltnguyen@pharmanet-i3.com