The future of clinical data managers is a thorny one. They are either about to be obliterated by electronic data capture (EDC), or given new prominence and authority as the systems they manage become even more important.
Either way, EDC should be done correctly, according to solid standard operating procedures and, yes, Good Clinical Data Management Practices (GCDMP) -- a topic of which we were, we confess, quite ignorant until we heard about it from Anthony Costello, whose day job is at Nextrials. Costello also happens to be vice chair and trustee of the 1,800-member Society for Clinical Data Management, which created the GCDMP back in the 1990s.
The published GCDMP now finds itself in version 4.2, with 20-some chapters. "The goal of the GCDMP is to establish best practices," notes Costello.
You could read the 20 chapters of the GCDMP in your spare time. Or you could sign up for a November 9, 2006 webinar on the topic. The SCDM is running it. The presenters for the webinar include Debra Jendrasek, manager of U.S. EDC Solutions at Chiltern International. Costello says hundreds of people have taken a short course in the GCDMP, and the webinar is a way to extend that process: "We're reaching beyond data management and trying to capture broader clinical teams, especially compliance teams and outsourcing people who are really wrestling with implementations at this point."
The target audience for the webinar includes: departments planning to implement EDC; departments who have already implemented EDC and are looking to gain insight on industry best practices; and EDC vendor selection committees.
In January, the SCDM will host another webinar on database validation. That session, among other topics, will cover the impact of data standards and compliance audits around a study database.