Johns Hopkins University and Webridge Use the Internet to Streamline Research Approvals Processes.

Business Editors/Health/Medical Writers/High-Tech Writers

PORTLAND, Ore.--(BUSINESS WIRE)--April 18, 2003

School of Medicine to Pull Disparate Users and Sites Together with Electronic Processing of Institutional Review Board (IRB) Applications

for Federally-Funded Medical Research with Human Volunteers

Webridge Inc., a leader in configurable web-based compliance systems, today announced that The Johns Hopkins University School of Medicine (JHUSOM) will use Webridge's Compliance Extranet software to streamline the IRB review and approval oversight processes for thousands of research projects involving human subjects. Implementation of a web-based system is expected to allow continuous improvements of oversight processes not previously possible with a paper-based IRB review mechanism. With the launch of its Webridge-based approvals system, JHUSOM is laying the foundation for a leadership strategy to advance the compliance aspects of human subjects research.

JHUSOM's IRB compliance system is expected to be available for medical researchers and IRB administrators in the 4th quarter of this year.

Automation Key to Managing Regulatory Complexity

With more federally-funded medical research than any other medical school in the country, Johns Hopkins University oversees new and continuing research programs on a scale found in few other universities in the world. As it does so, it must work within a framework of government-sponsored regulations subject to re-interpretation and constant change, according to Michael J. Klag, M.D., vice dean for clinical research at JHUSOM. "A key part of enhancing policies for effective and efficient IRB review of research lies in helping researchers to understand complex regulatory requirements that are described in a cornucopia of forms," Klag says. "An internet-assisted oversight process is the only avenue that makes sense."

With the new contract, JHUSOM will transfer these tasks to the web. Webridge's Compliance Extranet will now guide research teams through the correct entry of data in a structured series of steps similar to that found in today's popular tax preparation software. In addition, data checks will prompt researchers for missing information and provide them information links to explain requirements. "The result," Klag says, "is fewer errors and more time spent on issues of substance."

Klag added that "better training is partly the answer. However, navigating though forms to select the appropriate ones to describe research procedures and then following instructions to complete forms correctly remain challenges for a researcher to overcome anew on every proposal. Even simple mistakes can occasion hours of corrective IRB administrative work."

Ties Diverse Research Roles and Individuals Together

Another demand of research oversight is that collaborative research is frequently spread across geographic areas and involves work with any number of external organizations. A large organization such as JHUSOM must facilitate application coordination among research contributors as well as critical reviews by IRB committee members and administrators who oversee the conduct of the research. Providing everyone involved in the process an appropriate view of information is essential to meeting regulatory guidelines for securing information. Paper duplication and file folder routing takes days and weeks of routine transit time. The new JHUSOM Compliance Extranet will update dispersed team members of application status changes, approvals and correction requests in an automated and timely fashion. "It's clear that individuals, whatever the company or geographic locale, must be able to use the Internet on team research or team reviews," said Dave Brinker, CEO of Webridge. "Compliance Extranet allows institutions to control access precisely to centralized compliance data or approval processes without compromising security. We think this is a fundamental advantage for institutions like JHUSOM who are working with so many other institutions, contractors and collaborators."

About Webridge

Webridge is the world leader in configurable extranet portal software at innovative companies and institutions such as the University of Washington, Washington University Medical Center, Rohm & Haas, Honeywell, NCR, NEC and Xerox. When organizations need automation for confidential review and approval flows deployed on the Internet, Webridge extranets deliver 24x7. Easy task tracking, built-in auditing, document management, event-driven information alerts, and legacy system integration are all part of Webridge Extranet Based on the Microsoft .NET Framework, Webridge products configure today's business process for the challenges of tomorrow. For more information, go to www.webridge.com.