Advanced Topics in Signal Detection for Clinical Trials Using CDISC SDTM Data Structures
October 28, 2008 1:00pm-4:00pm

Thanks to the growing acceptance and widespread adoption of standardized data in CDISC SDTM format, sponsor companies of all sizes are recognizing the opportunity to explore the safety of a drug product in development in ways that were once not possible. This workshop will examine some of these enhanced possibilities for detecting detailed signals in safety data from standardized data.

Part 1 of this workshop will discuss approaches for using Phase Forward’s CTSD product for instream safety review of blinded studies prior to database lock, including:

• Maintaining the blind
• Addressing critical review needs (such as coding) while data is in transition
• Ensuring that coding is available to safety reviewers

Part 2 will explore how to use CTSD advanced signal detection and analysis features as part of an overarching risk management process within clinical development for locked, unblinded studies. Topics will include:

• Use of pooled studies for integrated analysis
• Working with complex study designs
• Advanced analysis methods

Workshop Leaders: Wayne Kubick, Robbert P. van Manen, and Bob Zambarano

To register for the conference
To view our preliminary agenda