Considerations for an SDTM Compliant Study Definition


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Considerations for an SDTM Compliant Study Definition

  1. 1. 2009 Annual ConferenceNew Orleans, LA Considerations for an SDTM Compliant Study Definition Steven Rifkin Sr. Director of Consulting BioPharm Systems
  2. 2. Topics• History of the SDTM• Horizontal Collection vs. Vertical Reporting• Variable Names• Date Formats Oracle Clinical and the SDTM
  3. 3. CDISC Organization• Clinical Data Interchange Standards Consortium – CDISC started in 1999 – Is a non-profit organization – Data models are created by industry volunteers – Mission: to develop & support global, platform- independent data standards that enable information system interoperability to improve medical research & related areas of healthcare Oracle Clinical and the SDTM
  4. 4. CDISC Models Acronym Title Use Clinical Data Acquisition DataB CDASH Standards Harmonization CollectionR Study Data Tabulation Model Content I SDTMD Analysis Dataset Model ContentG ADaM / Case Report Tabulation Data MetadataH Define.xml CRT-DDS Definition SpecificationL7* ODM Operational Data Model Format LAB Clinical Laboratory Model Content PRG* Protocol Representation Content * under development Group Oracle Clinical and the SDTM
  5. 5. SDTM• Study Data Tabulation Model• Goal: – Define a global standard for study data tabulations – Standardize regulatory submissions – Currently, de facto standard between the CROs and sponsors• Focus on study data tabulation content• Requested by FDA for all submissions Oracle Clinical and the SDTM
  6. 6. SDTM IG 3.1.2 Oracle Clinical and the SDTM
  7. 7. SDTM Model History• 2001: Submission Data Domain Models Version 1.0• 2002: Submission Data Domain Models Version 2.0 – Well received by industry – Major shortcomings (focus on safety domains only)• 2003: Submission Data Domain Models Version 3.0 – Standard for all clinical trial data – Based on data modeling (e.g. events, interventions and findings)• 2004: SDTM 1.0 - SDTM IG 3.1 – First version intended for implementation• 2005: SDTM 1.1 - SDTM IG 3.1.1 – Enhancements resulting from FDA/industry pilot testing• 2009: SDTM 1.2 - SDTM IG 3.1.2 – Major enhancements, expanded model Oracle Clinical and the SDTM
  8. 8. Horizontal Collection vsVertical Reporting• SDTM Domains are modeled (and reported) in a vertical manner – In many cases, this structure can be easily modeled using OC Repeating Question groups • CM, AE and PE domains are examples – In other cases, this vertical reporting structure leads to difficulties if OC repeating Question groups are used • VS Domain is an example to be discussed here Oracle Clinical and the SDTM
  9. 9. VS Domain in the SDTM USUBJID VSTESTCD VSPOS VSORRES VSORRESU 100 SYSBP STANDING 120 mmHg 100 DIASBP STANDING 80 mmHg 100 PULSE 55 BEATS/MIN 100 HEIGHT 210 LB 100 WEIGHT 69 IN• Simplified VS Domain Structure• Indicates individual records for each VS finding even though two findings may be related Oracle Clinical and the SDTM
  10. 10. Modeling the VS Domain in OC• Could create a “vertical” structure in OC – Questions for VSTESTCD, VSPOS, VSORRES etc – Put these questions in a Question Group – Make the Question Group repeat • Supply repeating defaults• Similar to LPARM, LVALUE model for normalized lab data• Default extract view mimics the way the SDTM reports So what’s the problem? Oracle Clinical and the SDTM
  11. 11. Vertical OC as Model for SDTMVS Domain: Difficulties• Awkward Data Entry – Physicians used to entering 120/80 as one measurement not two • Can be somewhat minimized in RDC Graphic Data Entry and training DE for Paper Studies• Limit utility of OC Univariate Discrepancies – The univariate checks can not vary with each repeat – e.g. different high/low limits for sysbp and diasbp • May be able to write a complex multivariate to accomplish this however• Validation checks between repeats are more difficult to create Oracle Clinical and the SDTM
  12. 12. Solutions• Model Horizontal and reformat in extract view definitions• Model Horizontal and post-process in SAS• Create a Collection QG (horizontal) and a Reporting QG (vertical) for the vital signs – Entry into the Collection QG all normal univariate checks and “easy” multivariate – Use a derivation routine to derive data from the collection QG to the reporting QG – Place both in a single DCM Oracle Clinical and the SDTM
  13. 13. Two Question Groups for Vital Signs• Horizontal – Typical non-repeating QG with Normal OC functionality and layouts• Vertical – Create a repeating question group with the SDTM questions like VSTESTCD, VSORRES, etc. – Use protected repeating defaults for VSTESTCD and VSTEST (cannot make these fields not displayed) – Make other questions in this question group “non-displayed” Oracle Clinical and the SDTM
  14. 14. Collection to Reporting DerivationProcedure• Could create a procedure for a standard VS domain – Assumes the names of the fields in the collection DCM and the repeat number into which this field will be derived• Could create a more general routine with a database package and assumptions – E.g. assumptions like collection question name will be the same as the TESTCD in the reporting QG, names of subsidiary questions in HELP text Oracle Clinical and the SDTM
  15. 15. Extract Views for Two QG Solution• Will get two default extract views – The non-repeating “collection” view can be dropped or ignored – The repeating “reporting” view can be used for the submission Oracle Clinical and the SDTM
  16. 16. SAS Names …• Many SDTM Variables have an 8 character length• OC supports using 8 characters, but, usually, it is not recommended to use 8 – Extended attributes could add one character at end and multiple occurrences of a question will add another – If name is 8 (or at eight because of additional extended attribute character) will not be able to create multiple occurrences• SDTM uses multiple occurrences only in the CO Domain, so not usually a problem• Extended Attributes could cause problems Oracle Clinical and the SDTM
  17. 17. SAS Names …• The Extended attributes are created when the Global Library Question is created. – If length of SAS Name is 8, the last character of the name is truncated and the extended attribute character is added to name the extended attribute• Problems occur when the extended attribute character added is the same as the last character removed• Problem doesn’t appear until the views are actually generated Oracle Clinical and the SDTM
  18. 18. SAS Names:Solutions• Make sure the extended attributes are not part of the view definition – Usually not part of the SDTM submission anyway, although may be useful for analysis• Change the name of the extended attribute in the view definition – Can run a SQL statement to indicate where there are duplicate column names and change just these names• Change the Extended Attribute names in the GLib Oracle Clinical and the SDTM
  19. 19. Date Formats …• Oracle Clinical stores and reports dates in the YYYYMMDD format – Time is collected as separate variable in HHMMSS format (Military) – Partial dates and times are possible• SDTM requires dates in the ISO 8601 format YYYY-MM-DDThh:mm:ss and reported as __DTC variables in the domains• Differences in how “missing significant” data is recorded – Unknown year is possible in SDTM but not in OC Oracle Clinical and the SDTM
  20. 20. Date Formats: Solution• Use a database package to convert from 2 OC fields to a single __DTC field for the SDTM• Package can include use of a third input AM/PM so that military time need not be used in OC Oracle Clinical and the SDTM
  21. 21. Some good things• Copy Groups – Make its easy to create all Domain objects in a single group and copy “standard” to target study• RDC – Might make some entry considerations for Horizontal vs Vertical easier to handle Oracle Clinical and the SDTM
  22. 22. Summary• SDTM and other CDISC Standards are evolving• Modeling a completely compliant submission in OC can be problematic• Workarounds exist for some of the common problems to reduce amount of post processing Oracle Clinical and the SDTM
  23. 23. Acknowledgements Prof. Dr. Jerry Welkenhuysen-Gybels Nico De Leeuw Oracle Clinical and the SDTM
  24. 24. Contact Information Steve Rifkin Biopharm Systems 908 822 0553 Oracle Clinical and the SDTM
  25. 25. ?Oracle Clinical and the SDTM
  26. 26. Steve Rifkin has almost 14 years of experience working with theOLS Product Suite. As an Functional Consultant, and then as aPractice Manager with Oracle Consulting in the Oracle ClinicalGroup, Steve has assisted over 60 companies with implementationof Oracle Clinical, RDC and TMS. He has led the implementationprocess and has provided training and performed custom coding.Since joining Biopharm Systems in 2000, Steve has beenresponsible for developing Oracle Clinical training courses, andproviding training and implementation services for Biopharmclients. Oracle Clinical and the SDTM