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Spectrum Leads Clinical Research Unit Initiative

October 2021

The School of Medicine (SoM) Dean’s office launched the Clinical Research Unit (CRU) initiative in 2019 to enhance review and oversight of clinical research activities. Fifty percent of School of Medicine clinical departments now have at least one CRU, and because of their success, the SoM is moving towards enterprise-wide CRU adoption and implementation.

“The primary goal of CRU reviews is to support researchers’ work by providing guidance and information to ensure study success.” – Dr. Ruth O’Hara, Senior Associate Dean for Research and Spectrum CTSA PI and Director

Established by a team from Spectrum, Stanford’s Center for Clinical and Translational Research and Education, CRUs are charged with the continuous development and improvement of a robust, well-organized, and productive clinical and translational research program.

A CRU is composed of designated faculty and staff engaged in clinical research who review proposed studies within their department/division for feasibility and alignment with department/division goals. CRU reviews may result in adjustments to the study design to increase the quality of the research by ensuring that the hypotheses are testable and that the protocol design is aligned with the research objectives. Benefits also include:

  • Assistance with budgeting,
  • Recruitment support, and
  • Addressing feasibility issues early in the process.
     

“The primary goal of CRU reviews is to support researchers’ work by providing guidance and information to ensure study success,” explains Senior Associate Dean for Research and Spectrum CTSA Director, Dr. Ruth O’Hara. “We believe that this assistance will increase the quality and efficiency of clinical research across the School of Medicine, lead to more expeditious RMG and IRB evaluations, and result in subsequent study approval.”

The Spectrum team holds quarterly meetings with CRU faculty and staff leads to share lessons learned and best practices. Also, Spectrum provides research faculty with IT platforms via OnCore’s clinical trial management system to assist in the management of studies submitted for CRU review.

To learn how Spectrum can assist in setting up your CRU, please contact Peg Tsao at pegt@stanford.edu.