TechTrainings by Clinovo

CDISC Standards for SAS Programmers

Number of weeks: 8
Frequency: Once a week
Time: From 6pm to 9pm PST
Dates: From 9/9 to 10/28

Course Description:  This course will give you an overview of CDISC standards: ODM, SDTM, ADaM and Define.XML. It will teach the basics of XML and expand on how that is implemented in operational data models. You will learn through examples how to transform legacy data into these standards. The use cases will include exchanging data, archival, and electronic submission to regulatory agencies such as the FDA submission.

Syllabus:

  1. Overview of all CDISC data models including: ODM, SDTM, ADaM and Define.XML. Example use cases will be reviewed.
  2. Details on the ODM data models and how it is the parent which SDTM, ADaM and Define.XML are based upon. Exercises will include creating parts of the XML models for ODM.
  3. A continuation on the details of the ODM with example uses cases for communication with CRO and regulatory Submission to FDA.
  4. Connection between ODM and SDTM.  This also includes the use of archival of data after submission.
  5. Details on SDTM data models. This will include example transformation from legacy data into SDTM data models.
  6. Exploration of different techniques of applying data transformation to SDTM with emphasis on specifications and validation.
  7. Details of the DEFINE.XML data models.  It will describe methods of generating this from SAS and other tools. 
  8. Validation of all the data models with the focus on SDTM, ADaM, and Define.XML as those are involved in electronic submission.
 

 

Course Prerequisites:

  • Basic working knowledge of SAS including data step and basic use of SAS macros.
  • Basic computer skills are required.
  • Some experience with clinical data is preferred but not required.
  • Notions in statistics are helpful.


Instructor: Sy Truong, Co-founder and President at MXI (Meta-Xceed, Inc.)

Sy Truong is the Co-founder and President of MXI (Meta-Xceed, Inc.) since 1997.  Sy is SAS Certified and is SAS Institute Alliance Partner.  As an executive for MXI, he provides software solutions within the Pharmaceutical Industry specializing in CDISC data standards, SAS validation, electronic submission, data analysis and reporting. Sy is one of the committee members of the Bay Area SAS User Group (www.basas.com).  He is a frequent contributor and presenter at PharmaSUG, WUSS, and SAS Global Forum conferences. He has also authored the book CDISC Implementation, Lessons Learned from Real Life Examples.

Access: In-person at Clinovo's offices (Sunnyvale, CA) or remotely via GoToMeeting.

Referral program: Please refer your friends or colleagues! We offer you as well as the referred student a $50 gift card.

 

Upcoming Class
From 9/9 to 10/28
Early Bird Until 08/10
Links

CDISC Standards for SAS Programmers

$1,990

Contact us              Register Now

 

Other class:

 

Contact information:  Molita Sorisho, Marketing Manager | Molita.Sorisho@clinovo.com | 408-940-3941

Refer a friend and win a $50 gift card

More than 50 students from leading organizations have chosen the TechTrainings.

 

AmgenPharmacyclicsGileadGSK

ArquleOnconova TherapeuticsOnyx PharmaceuticalErnest Gallo Clinic & Research Center

Bavarian NordicMedImmuneCPC Clinical ResearchExelixis

University of North DakotaCorceptWake Forest UniversityGen Re