New study management, regulatory compliance resources for researchers

Two new groups aim to help Stanford researchers manage clinical studies and comply with government regulations.

Spectrum, the Stanford Center for Clinical and Translational Research and Education, recently established two new groups to assist Stanford researchers in managing studies and complying with the labyrinth of government regulations associated with clinical research.

OnCore training

The first, Spectrum’s OnCore support team, is currently scheduling training sessions for groups interested in using the OnCore clinical research management system. The schoolwide adoption of OnCore will make it easier for investigators to manage clinical research and monitor participant recruitment. OnCore also provides tools for multisite study management. For more info, contact the manager of this group, Yona Shulaker, at shulaker@stanford.edu.

Clinical research guidance

The second resource, the Clinical Research Quality Office, is staffed with experts who can help research teams understand clinical research regulations and adopt best practices. They can also help groups prepare for audits by industry sponsors or the Food and Drug Administration.

This office will be developing School of Medicine clinical research policies, standard operating procedures and systems for tracking regulatory compliance. It is currently focused on tracking Stanford studies listed on ClinicalTrials.gov and training researchers on upcoming results-posting regulation changes. It is under the leadership of faculty director Mark Pegram, MD, professor of oncology, and administrative director Jennifer Brown, RN.



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