About Berkeley eProtocol

(updated 3/8/2011)

Background

A primary goal of UC Berkeley’s Research Administration and Compliance (RAC) Office is the active pursuit of practices that will minimize administrative burden on faculty, while ensuring compliance with the pertinent laws, rules, and regulations that govern research. For this reason, RAC acquired and developed the Key Solutions Inc. eProtocol System, with funding from the Campus Technology Council (CTC), to replace an old-fashioned and inefficient paper-based review process.

eProtocol is a research compliance management system which can be accessed from any desktop via CalNet Authentication. The system automates many aspects of workflow and operations for review committees, staff, and researchers, including electronic protocol preparation, submission, routing, review, tracking, approval, and closeout. Berkeley eProtocol is designed to support the administration of research involving human as well as animal subjects. Once both modules are up and running, it will provide researchers with a common user interface for the web-based preparation and management of Committee for Protection of Human Subjects (CPHS) and Animal Care and Use Committee (ACUC) protocols.

CPHS began the transition to eProtocol in March 2009 with the Exempt review process, while simultaneously working to test and adjust the Non-Exempt (Expedited and Full Board) review processes. In December 2009, the system was opened to Non-Exempt applications. Shortly thereafter, researchers with approved protocols that pre-existed the new system were asked to enter them into eProtocol as new applications prior to the expiration of their current approval. As federal regulations permit approval of human subjects research for a period of one year at a time, it was anticipated that it would take just over a year for all pre-existing protocols to be entered into the system. The full transition to eProtocol was completed in February 2011.

The roll-out was of course not without its challenges. As the submission volume increased and the system was put through its paces, additional adjustments and improvements were needed. Thanks to the collaborative efforts of Key Solutions, RAC Information Systems, Information Services and Technology, Office for Protection of Human Subjects staff, CPHS members, and the UCB research community, the implementation of Berkeley eProtocol has been a success. We hope that those who use the system will agree that it has overcome the business problems that it was intended to address.