Western Institutional Review Board wanted to reduce the administrative burden of regulatory submissions on clinical trial investigators and coordinators, says Stephen Rosenfeld, president. "IRB review is often dominated by regulatory compliance issues rather than ethics," he says via email. The IRB can appear as "one of several roadblocks" to investigators, rather than a partner in moving research forward responsibly and safely.
WIRB had implemented its own proprietary Part 11-compliant workflow system in 2003, but it had become difficult to keep the system in step with industry practices. Rosenfeld wanted to improve study coordination and submission-monitoring services. His challenge was to increase support for automated processes that accelerate and improve IRB administration and compliance oversight.
WIRB chose the Click Commerce eResearch Portal software. The system helps to "move the compliance and submission process details up front, so that these issues are settled and the IRB is able to concentrate on substantive review," says Rosenfeld. "This change will speed the entire process and give investigators confidence that their submissions are complete before they go to the Board."
Rosenfeld says that, given the 400 organizations that WIRB serves, he was looking for a flexible system that could be maintained by WIRB staff and handle high review volume.
- here's the announcement