The Meeting – 05/29/2008 Bay Area CDISC Implementation Network May Meeting

This will be a big year for new releases of CDISC standards.  In the next few months we will see the publication of the official release of the SDTM Implementation Guide version 3.1.2, the release for public comment of the first real Implementation Guide for ADaM, and the publication of several CDASH domains.  This meeting will provide us with status updates and sneak peeks for all these releases.

Fred Wood, the Team Lead for CDISC’s SDS team, which is responsible for SDTM, will be here to present “Update on the Status of SDTMIG v3.1.2: What's in Scope and What Will Wait.”  Fred is one of the principal contributors to the SDTM, and is one of the authors of the Implementation Guide, and a founding member of the SDS team.  Other CDISC involvement includes co-lead of the SEND team, membership on the CDISC Technical Leadership Committee and involvement in teams for representing the SDTM in XML mapping the SDTM to BRIDG, and SDTM modeling for device data.  Fred actually has a day job, too.  He is Principal Consultant in the Clinical Data Strategies group at Octagon Research Solutions.

The second presentation will be “ADaM Implementation Guide: It’s Almost Here.  Are You Ready?” by Sandra Minjoe, Principal Statistical Programmer Analyst at Genentech, where she leads CDISC strategy development and implementation.  Sandra has been a member of the ADaM team since 2001.  She was one of the originators of both the subject-level and adverse event structures, and is now working on developing training materials.

The ADaM Implementation Guide has been through an internal CDISC review, meaning that other CDISC teams have given their feedback, and the ADaM team is now making updates based on that feedback.  By the time of this meeting, the Implementation Guide should be released for public comment.  This presentation will highlight some of the main features of the Implementation Guide, describe the data structures within it, and help you with your review and adoption plans.

We have had quite a few requests for more information about the CDASH project, which Rhonda Facile of CDISC and Dorothy Dorotheo of InterMune did a presentation about at the December meeting.  Dorothy has agreed to give us a short update on the status of the project.

The timing of this meeting also happened to coincide with a visit to the Bay Area by Landen Bain, CDISC’s Liaison to the healthcare information community.  He has offered to come and give us an introduction to CDISC’s Healthcare Link initiatives. 

An example is a cooperative effort he leads between CDISC and Integrating the Healthcare Enterprise to enable data capture for clinical research from within Electronic Health Record systems.  This work brings together pharmaceutical, EHR and electronic clinical research technology companies to develop use case scenarios around interoperability.  Landen brings some impressive credentials, having been CIO of both the Duke University Health System and Ohio State University Hospitals.

See you there!

John

John Brega
Standards Implementation and Integrated Safety
PharmaStat LLC

Web: www.pharmastat.com
Email: JBrega@PharmaStat.com
Phone:   510-482-2432