University Times

Pitt and two hospitals that sponsor human clinical research have formed a consortium and agreed to a standardized, common set of information for new protocols that soon can submitted on-line.

Pitt, Magee-Womens Hospital and Children’s Hospital of Pittsburgh will use Webridge’s Compliance Extranet software to automate their Institutional Review Board (IRB) approval oversight processes.

The system, expected to be implemented this fall, will streamline the electronic submission and review of new research studies involving human subjects at all three institutions and enable the electronic submission, review and tracking of research proposals.

Cumulatively, the three institutions have more than 5,000 active research protocols. The new system will support all new human subject research compliance oversight for the three institutions including exempt, minimal risk and full-board reviews, the three basic levels of IRB clinical research approvals.

“Many of our researchers have active studies at all three facilities,” said Clifford Schold, associate vice chancellor for clinical research and head of Pitt’s Office of Clinical Research, which will implement the new web application. “We needed a solution that would allow us to standardize the submission process for the researchers, while still providing flexibility for each institution’s individual needs. Webridge provided us a common foundation that can easily be tailored to the unique needs of each organization.”

For any new research project, an investigator is required to submit a variety of background information about the proposed study including funding, medical procedures, new drugs and devices, study population and expected results.

The new system is expected to improve the quality of the information provided, officials said. “We envisioned a system similar to the leading tax preparation software programs,” stated Dennis Swanson, director of the Research Conduct and Compliance Office at Pitt. The form-based application guides a researcher through a series of questions. Based upon answers to one question, the program branches to the next set of appropriate questions, providing helpful hints and links to related information along the way. By the end of the process, the researcher will have a complete protocol application ready for submission to the IRB.

The Webridge system also will eliminate the current requirement to submit multiple paper copies of an application to the IRB.

In addition to new research submissions, the Webridge software will handle ongoing processing of amendments, adverse events, continuing reviews and complaints. Researchers and administrators will be able to see instantly the complete history of a research protocol. Using an integrated search capability, committee members also can scan the entire database for medical drugs and devices used in similar studies. Committee members will review the information on-line, posting comments in a private, secure review area. Subscription-based automatic e-mail notification will keep investigators updated on the latest status of their protocols.

For more information on the system, visit the OCR’s web site at: www.oorhs.pitt.edu/ClinicalResearch/

—Peter Hart