Monday, April 14, 2008—Pre-Conference Workshop
1:00 PM - 4:30 PM

Advancing the Discipline of Managing Clinical Trial Data Using EDC

Electronic Data Capture (EDC) is routinely used in hundreds of clinical trials each day. More sponsors are choosing EDC as either an alternative or a compliment to paper-based clinical trials. The Society for Clinical Data Management (SCDM) is dedicated to advancing the discipline of managing clinical trial data. As part of its mission to globally promote quality and continuous improvement in data management activities, SCDM has prepared the Good Clinical Data Management Practices (GCDMP) document. This session presents key aspects of the recently updated GCDMP chapter on EDC.

The session is structured as an interactive tutorial that looks at the many aspects of EDC that are particularly important from a data management viewpoint. EDC is explored in terms of data management activities pertinent during the Study Startup, Conduct, and Close-Out Phases of a clinical trial. In particular:

• System considerations – Thin or Thick Client
• Integration of EDC and non-EDC sources
• SOP considerations
• Preparing your organization to execute a trial in EDC
• Practical considerations in developing eCRF and Edit check specifications
• Managing the ‘bells and whistles' EDC systems offer
• Training considerations
• Managing change in EDC studies
• Partnering with Clinical research to get the most efficiency during data cleanup and lock from using EDC
• Data Archival considerations