"Standards from the Start" Session at 2015 CDISC International Interchange
It was my privilege to chair the "Standards from the Start" session at the Interchange in Chicago this year. We had a great lineup of presenters who walked us through CDISC standards solutions to support increased efficiency and quality through the use of standardized protocol templates, standardized CRFs and standardized metadata repositories.
I was especially impressed to see the presentation by Angela N. Johnson about how GE Healthcare is using the Protocol Representation Model (PRM) with common word processing software to write protocols in a standard protocol template. She reports that her company has achieved not only faster turnaround times with protocols, but by using a high quality protocol template, they have also minimized the need for protocol amendments. The downstream effect of reducing protocol amendments is a huge gain in itself because it also reduces CRF/eCRF modifications, and all the related programming (edit checks, output files, analysis programming, etc.) that occurs following a protocol amendment.
Companies are beginning to realize the benefits of implementing the CDISC standards starting at the beginning of their clinical research process, rather than waiting until the end and then trying to map everything to SDTM. This will not only give them a competitive edge with reduced timelines and costs, but it will also increase the value of their data and ultimately support faster discovery of therapies and cures to help patients.
By Shannon Labout, CDISC VP of Education