Copyright © 2013 Quintiles FA vs. SUPPQUAL Facilitator: Riekert Henning, 11 April 2013

2 Agenda Introduction Guidelines for Resolution Decision Chart Some Examples FAQ & Discussion Conclusion

3 Introduction More people are becoming familiar with CDISC and the SDTM data standard and it seems that it should be getting easier. In practice virtually every study seems to have forms or modules that challenge even the most seasoned CDISC users. One of these challenges is the “floating supplemental qualifier” or “lost child” This situation is not CDISC compliant, so we need to address it !

4 Guidelines for Resolution 1)Does it actually belong in a SDTM domain and not SUPPQUAL? >Is it actually topic data and possibly just not presented in the same way as other topic data? Does it have qualifiers of its own? >It may not be the same class as other data collected on the page, but is still topic data – perhaps it is Findings About an Event or Intervention. Use the new FA domain! 2) Is there a not-so-obvious parent? >Review the context to determine what this data is describing or related to. It may be related to information in another section of the form or on another form altogether. Alternately, it may be related to the entire form or be a subject-level qualifier.

5 Guidelines for Resolution 3) Is the data actually needed? >If the data is purely administrative (prompt questions, etc.), it does not need to be mapped. >Is the data clinically important or useful for medical review? >Is the data needed for any tables, figures, or listings? 4) When all else fails: It’s time to get creative >Perhaps the collection field itself indicates the topic data and a record can be generated in one of the SDTM domains to link the qualifier to. >If there is no other solution and you must have this data captured in SDTM, then you may need to create a custom domain to hold the values from these data fields. Continued…

6 Guidelines for Resolution Floating Variable (“Lost Child”) Find a Parent New Record in Existing Domain SUPPQUAL Do Not Map Find Alternate Mapping Custom Domain FA A few options are available:

7 Decision Chart

8 Examples Example 1:

9 Examples Example 1 continued…

10 Examples Example 2:

11 Examples Example 2 continued…

12 Examples Example 3

13 FAQ & Discussion Today’s Panel: Sunet Botha – Clindata Biostats Yolande van Rooyen – Clindata Biostats Amorette Kruger – Quintiles Biostats Laurent Marais – Quintiles IPT/DM Riekert Henning – Quintiles IPT/DM

14 FAQ & Discussion What does the term ‘Findings About’ refer to ? a)Data that do not describe an event or intervention as a whole. b)data that indicate the occurrence of related symptoms. The variable, --OBJ, is unique to Findings About. In conjunction with FATEST/CD, it describes what the topic of the observation is. How do we determine what goes into FAOBJ and FATEST/CD ? a)FAOBJ is to link FA to an Events or Interventions domain; b)FATEST Codelistis findings associated with the event in FAOBJ; How are the FA records linked back to the original record ? a)Record may be linked back via RELREC. Questions

15 FAQ & Discussion What does the term ‘Findings About’ refer to ? a)Data that do not describe an event or intervention as a whole. b)data that indicate the occurrence of related symptoms. The variable, --OBJ, is unique to Findings About. In conjunction with FATEST/CD, it describes what the topic of the observation is. How do we determine what goes into FAOBJ and FATEST/CD ? a)FAOBJ is to link FA to an Events or Interventions domain; b)FATEST Codelistis findings associated with the event in FAOBJ; How are the FA records linked back to the original record ? a)Record may be linked back via RELREC.

16 FAQ & Discussion What does the term ‘Findings About’ refer to ? a)Data that do not describe an event or intervention as a whole. b)data that indicate the occurrence of related symptoms. The variable, --OBJ, is unique to Findings About. In conjunction with FATEST/CD, it describes what the topic of the observation is. How do we determine what goes into FAOBJ and FATEST/CD ? a)FAOBJ is to link FA to an Events or Interventions domain; b)FATEST Codelistis findings associated with the event in FAOBJ; How are the FA records linked back to the original record ? a)Record may be linked back via RELREC.

17 FAQ & Discussion How do we determine what goes into FAOBJ and FATEST/CD ?

18 FAQ & Discussion How do we determine what goes into FAOBJ and FATEST/CD ?

19 FAQ & Discussion What does the term ‘Findings About’ refer to ? a)Data that do not describe an event or intervention as a whole. b)data that indicate the occurrence of related symptoms. The variable, --OBJ, is unique to Findings About. In conjunction with FATEST/CD, it describes what the topic of the observation is. How do we determine what goes into FAOBJ and FATEST/CD ? a)FAOBJ is to link FA to an Events or Interventions domain; b)FATEST Codelist is findings associated with the event in FAOBJ; How are the FA records linked back to the original record ? a)Record may be linked back via RELREC.

20 FAQ & Discussion What does the term ‘Findings About’ refer to ? a)Data that do not describe an event or intervention as a whole. b)data that indicate the occurrence of related symptoms. The variable, --OBJ, is unique to Findings About. In conjunction with FATEST/CD, it describes what the topic of the observation is. How do we determine what goes into FAOBJ and FATEST/CD ? a)FAOBJ is to link FA to an Events or Interventions domain; b)FATEST Codelist is findings associated with the event in FAOBJ; How are the FA records linked back to the original record ? a)Record may be linked back via RELREC.

21 FAQ & Discussion How are the FA records linked back to the original record ?

22 FAQ & Discussion What does the term ‘Findings About’ refer to ? a)Data that do not describe an event or intervention as a whole. b)data that indicate the occurrence of related symptoms. The variable, --OBJ, is unique to Findings About. In conjunction with FATEST/CD, it describes what the topic of the observation is. How do we determine what goes into FAOBJ and FATEST/CD ? a)FAOBJ is to link FA to an Events or Interventions domain; b)FATEST Codelist is findings associated with the event in FAOBJ; How are the FA records linked back to the original record ? a)Record may be linked back via RELREC.

23 CONCLUSION The floating supplemental qualifier is a compliance issue which must be addressed prior to submitting data. Any “lost children” will be identified by compliance checking tools such as WebSDM or OpenCDISC. A thorough review of mapping specifications can help to catch this issue up front, but one must be careful in determining an appropriate solution which adheres to CDISC SDTM guidelines and specifications, keeping in mind the full context of the situation and the impact of the modified mapping strategy in terms of programming, medical review, and regulatory review.

24 Any Other Question ?