Transcript SAS Programming and Careers

Bob Hull, Kris Ilano, Ed Lombardi
SANDS Dec 2012
PDUFA V
 http://www.fda.gov/ForIndustry/UserFees/Prescriptio
nDrugUserFee/ucm272170.htm
 Goals and Procedures (see section XII):
 http://www.fda.gov/downloads/ForIndustry/UserFees/P
rescriptionDrugUserFee/UCM270412.pdf
 Draft Guidance on format of electronic submissions Dec 31 2012
 Final Guidance – 12 months after public comment
period
 Required – 24 months after final guidance
PDUFA V - continued
 Goals and Procedures (see section XII):
 Terminology / Therapeutic Area Standards – 2017




Includes terminology and detailed implementation guides
58 therapeutic areas
Draft project plan – June 30 2013
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/For
msSubmissionRequirements/ElectronicSubmissions/ucm287
408.htm
Kris Ilano
SANDS Dec 2012
ADaM - Structures
 ADSL
 BDS
 Time to Event
 ADAE
 Occurrence – being developed
 IG Update – being developed
ADaM - Implementation
 Problem areas
 Less rigid structure than SDTM
 Lack of OpenCDISC checks
 BDS can’t do everything
 What goes into ADSL?
 Focus on the Key Principles
 Analysis Ready
 Traceability
 Therapeutic Areas
 Data Guide
Kris Ilano
SANDS Dec 2012
SDTM I.G. Timeline
 3.1.1 – 2005
 3.1.2 – 2008
 3.1.2 Amendment 1 – 2011
 3.1.3 – 2012
 3.1.4 (Draft) – 2012/2013
Keeping up with Updates
 Check website regularly (www.cdisc.org)
 Sign up for webinars
 Volunteer for CDISC teams
 Local Meetings (SANDS, San Diego CDISC Users
Group)
 Mailing list
 openCDISC
 CDISC
 FDA
Which version to use?
 What do we (primarily) use?
 3.1.2 Amendment 1
 Why?
 openCDISC validation checks are available

FDA openly says that they use openCDISC checks
 in-house define.xml process

Each new version of the SDTM I.G. will likely require at least a
few updates to your define.xml template
Preparing for Future I.G.’s
 Read the DRAFT versions/provide comments
 Make updates to in-house specifications file
 Version control is key (keep old versions)
 Make updates sooner, rather then later
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Avoid scrambling to make updates at the very last second
Allow for adequate QC time
Make updates to in-house specifications file
 What other in-house processes need to be updated?
 Example: define.xml
When to switch?
 After all affected internal processes are updated and
QC’d.
 After openCDISC has updated their validation checks
 Sponsor request
When NOT to switch?
 Upcoming ISS/ISE where previous studies are using an
older version of the I.G.
 There are advantages is using the same version of the
I.G. across all studies
 Not 100% sure all processes have been updated
effectively and accurately
 Currently there is NOT a mandated version to use (3.1.2
and up is the norm)
 Sponsor Request
Summary
 SDTM is always evolving and constantly changing
 Keep up with CDISC updates
 Update affected files and processes sooner rather than
later
 openCDISC is key
Bob Hull
SANDS Dec 2012
Define.xml – The Standards
 Version 1.0 Released in 2005
 Version 2.0 Released for comments in Sep 2012
 http://www.fda.gov/forindustry/datastandards/studyd
atastandards/default.htm
 Define.xml (only) for SDTM / ADaM
 Define.pdf for non-CDISC
Define.xml – The Standards
 Documentation of Derivations
 Conforms with OpenCDISC
 Data Guide for discrepancies
 FDA Releases Amendments (SDTM)
 FDA Releases Common Issues
Define.xml – Application
 Both SDTM and ADaM use it.
 Create style sheet for ADaM
 Define.pdf and Define.xml
 Based on personal experience with FDA
Define.xml – Outline of How
 Review Sample Define.xml
 Excel file Specifications
 Study & Documents
 Codelists
 Domains
 Valuelevel Metadata
 Variable Specs, part of SDTM/ADaM specs
Define.xml – Outline of How
 Edit Checks on Specifications
 SAS Program to Create Define.xml
 Define.xml is a text file
 Run OpenCDISC
 QC
Define.xml – The Options
 Develop Process, Create internally
 Strong Initiative, problem solving
 Two Weeks
 Hire Out along with SDTM, ADaM
 Less effort, more money
 Do Data and Specs, Hire out Final Step
 Middle ground cost & Work
 More communication
 Less development
Define.xml – The Future
 Define.xml 2.0 standards
 SDTM & ADaM
 Rework Processes
 Transition Period
 Nov 2009 SDTM 3.1.2 accepted by FDA
 SDTM 3.1.1 Studies Initiated 6/13/2011
Questions?
[email protected]
[email protected]
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