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Section for Statistical Programmers and Analysts
Web-based Training Series
Registration Fees:
Member of the Section for Statistical Programmers and Analysts: $40
ASA Member: $65
Nonmember: $85
Each registration is allowed one web connection and one audio connection. The Section for Statistical Programmers and Analysts encourages multiple persons to view each registered connection (for example, by projecting the webinar in a conference room).
Current Offerings:
Implementing CDISC Based Processes: General Solutions for Common Challenges: From ADaM to Tables and Figures
Presenters: Mario Widel (Roche Molecular) and Steve Kirby (ViroPharma)
Thursday, December 8, 2011, 3:00 p.m. to 5:00 p.m. Eastern time
Registration Deadline: Tuesday, December 6Clinical Data Interchange Standards Consortium (CDISC) standards are increasingly central to the drug development process. The CDISC Study Data Tabulation Model (SDTM) is well-established as the default standard for submission of clinical data to the FDA., and given recent regulatory support for the ADaM model, companies are encouraged to build analytical processes around "analyzable" ADaM. The very good news is that all that careful planning at the metadata level allows for efficient table and figure generation using just a few core processing tools.
Well-formed ADaM is designed and carefully documented based on the needed tables and figures across a submission. Starting with that well-formed ADaM data, the presenters share practical ways to efficiently leverage ADaM for tables and figures and fully meet the potential needs of downstream reviewers.
This presentation is designed for people and groups with a solid functional understanding of SDTM and broad familiarity with TFL generation using analysis data who are starting (or thinking about starting) to use ADaM for analysis. This is part three of a four part series that started with "From Source to SDTM," and "From SDTM to 'Analyzable' ADaM" and that will end with "Building Define.xml Data Documentation into the SDTM/ADaM Mapping Process.
Registration is Closed.Registered attendees will be emailed the access information for the webinar the afternoon of Tuesday, December 6.
Implementing CDISC Based Processes: General Solutions for Common Challenges: Building Define.xml Data Documentation into the SDTM/ADaM Mapping Process
Presenters: Luke Reinbolt (Pharmanet i3), Steve Kirby (ViroPharma) and Mario Widel (Roche Molecular)
Wednesday, January 11, 2012, 3:00 p.m. to 5:00 p.m. Eastern time
Registration Deadline: Monday, January 9Clinical Data Interchange Standards Consortium (CDISC) standards are increasingly central to the drug development process and are the default standard for use when submitting tabulations (CDISC SDTM) or analysis (CDISC ADaM) data to the FDA. Sponsors are expected to submit define.xml data documentation with all CDISC applications to the FDA. Well formed data contains all information needed to understand study results, but that information is typically not easily accessible to end users; combining the data with xml format data documentation gives end-users a data and documentation package that is complete and user-friendly.
Define.xml data documentation helps the data say "Hello" to reviewers and other downstream users with internal and external links to the level of information needed, from source CRF references to variable lists to code lists and comments associated with key content. Integrating the information needed to support the define.xml into the process of preparing to convert source data to SDTM format or SDTM to "analyzable" ADaM emphasizes the documentation needed to support submission data and allows the define.xml to be generated to support use and review of the data at each stage, from test transfer to final submission. Starting with the core levels of information (from study and variable characteristics to code lists) needed to support submission data, the presenters share practical ways to build the information needed for the define.xml into the mapping process and leverage the data and the mapping specs to create the define.xml.
This presentation is designed for people and groups with a solid functional understanding of data definition documents (define.pdf or define.xml) and data mapping specifications. This is part four of a four part series that started with "From Source to SDTM," "From SDTM to 'Analyzable' ADaM, " and "From ADaM to Tables and Figures."
Registration is Closed.Registered attendees will be emailed the access information for the webinar the afternoon of Monday, January 9.
About Webinars
System Requirements
Operating System: Windows 2000 to present, Macintosh OSX, Linux Redhat
Browser: Internet Explorer (IE) 5.5+, Firefox 2.0+, Opera 9.0+, Mozilla 1.71+, Safari 3.1
Other: Events with streaming audio or video require Macromedia Flash 8.0+
Hardware: 56Kbps Internet access. Speakers or headphones and cable modem, DSL, ISDN, or equivalent broadband needed to receive audio/video streaming (128K minimum).*Opera browser will not allow access to the Question and Answer feature of the console.
