Society For Clinical Data Management (SCDM)

Conference Highlights

Tutorial Sessions
Saturday, September 20, 2008
1:00 p.m. - 5:00 p.m.

CDASH Session
Rhonda Facile, CDASH Program Director, CDISC
Shannon Labout, CCDM, Senior Consultant, CSS Informatics, a Division of PPD

Many SCDM members will have by now already have heard about the Clinical Data Interchange Standards Consortium (CDISC)led Clinical Data Acquisition Standards Harmonization (CDASH) project. Indeed, the SCDM is a founding member of the CDASH Collaborative Group and several CDASH sub-group leaders are also SCDM members. To review, the CDASH initiative is an FDA Critical Path Opportunity (#45) that seeks to enable standardized collection of clinical research data at investigative sites. Through standardization of basic data collection elements, efficiencies can be achieved that will result in less confusion across sponsors, investigators and research sites and facilitating more efficient monitoring, audit, submission and review procedures. This pre-conference tutorial will provide attendees with the opportunity to hear the background, objectives, project organization and process as well as a survey of the 16 domains developed by the CDASH team. In addition, attendees will hear how CDASH intersects with other CDISC standardization projects i.e. terminology and the SDTM. The session will conclude with a presentation on the practical implementation of CDASH recommendations and (POSSIBLY) a presentation on CDASH and how it intersects with the SDTM.

Learning Objectives
At the conclusion of this session, participants should be able to:

Describe the benefits of CRF standardization for investigative sites and other stakeholders in clinical research.
Explain the CDISC Standards Development Process, and where the CDASH project is relative to this process.
Explain how CDASH collection fields can be used to create basic CRFs and XML style sheets and how this will facilitate good CRF design and minimize collection of unnecessary data elements and ensure consistency across a clinical program.
Describe how CDASH data collection fields are related to other CDISC standards, specifically the SDTM and Terminology.
Describe how CDASH can facilitate interoperability between clinical systems, e.g. facilitating collection of data from EHRs or between 2 clinical data systems between a single or multiple CROs and Sponsors).

Sunday, September 21, 2008
8:00 a.m. - 4:00 p.m.

Data Management Plans
Anita Walden, Manager Data Management, Duke Clinical Research Institute

This training session is intended for those who are developing their experience in outlining and documenting Clinical Data Management activities. The instructor will review documentation requirements and common practices. The session will include examples and exercises using a fully developed training protocol. Group discussions will be facilitated to benefit from common experiences and practices used across organizations.

Participants completing the training should accomplish the following objectives:

Define key elements in a Data Management Plan
Undertake gathering and organizing the information describing the data handling processes used for a clinical trial
Describe workflow for electronic and paper data collection, QC and related data processing procedures and metrics
Discuss clinical data management documentation requirements and rationale
Apply standards for creating, approving, and maintaining Data Management Plans

Keynote Presentation
Monday, September 22, 2008 9:00 a.m.-10:00 a.m.

This year SCDM is proud to welcome David Cottrell as its Keynote Speaker to kickoff the conference.

Mr.David Cottrell is President and CEO of CornerStone Leadership Institute, a multi-million dollar organization as well as one of the most recognized and profitable companies in the training and business publishing industry.

Mr. David Cottrell is an authority on leadership. As an internationally known author and speaker on the topic of leadership, he has been featured on public television and in numerous publications. Prior to founding CornerStone, Mr. Cottrell's business experience included senior management positions with Xerox and FedEx.

Mr. Cottrell's years of professional experience are reflected in more than 20 highly acclaimed books, including Listen Up, Leader; The Next Level; Leadership Courage, Monday Morning Mentoring and the best seller Monday Morning Leadership - a top ten leadership book for 20 consecutive months. He has developed an outstanding reputation as a premier professional speaker and has presented his leadership message to more than 250,000 managers worldwide.

To learn even more about David Cottrell, visit http://www.cornerstoneleadership.com/scripts/keynote.asp