The Obstetrics and Gynecology Clinical Research Unit

Anna Girsen, MD, PhD, the department’s research operations director

Stanford Medicine continues to make innovative strides to cultivate infrastructure and excellence in clinical and translational research. Over the past year, Stanford School of Medicine Clinical Research Units (CRUs) were created around groups (departments, divisions) to provide oversight, support, and peer review for all clinical and translational research protocols in the CRU portfolio.

As one of the first to pilot the program, the Obstetrics and Gynecology CRU has created an organizational framework at the departmental level that promotes high-quality clinical and translational research and operational success. The Ob/Gyn CRU's main functions are to peer-review all new clinical and translational research protocols and to advise investigators about departmental and external resources for their research work. These processes are coordinated by Anna Girsen, MD, PhD, the department’s research operations director, and faculty leads Deirdre Lyell, MD and Ruben Alvero, MD.

Once a new protocol is in development, peer-reviewers are selected from Ob/Gyn faculty and staff based on the investigators suggestions and the CRU leads recommendations. The unit utilizes OnCore ePRMS system to facilitate the electronic submission and timely review of protocols, streamlining the review process. All aspects of the protocol are reviewed in anticipation of submission. Reviewers provide feedback and suggest resources to develop and strengthen protocols for submission.

In addition to peer review of research and quality within the CRU, the department provides financial review in partnership with the School of Medicine’s Research Management Group.  Investigators also have access to a Grant Resource Library, containing examples of funded grants, budgets and other materials to aid in the development of the project.

The Clinical Research Unit systems offer unique opportunities for cross-departmental research collaborations and mentorship. In addition, we anticipate that the elevated quality of research protocols and proposals will translate into increased acceptance by regulatory and funding organizations. The development of this unit continues to further our mission: to improve women’s health through innovative and compassionate care, education, advocacy and discovery.