Obstetrics and Gynecology Clinical Research Unit

Our department created a Ob/Gyn Clinical Research Unit (CRU) to honor our commitment to maintaining high scientific and scholarly standards in research. Our CRU review process meets the Stanford University School of Medicine’s requirement that all new, prospective research studies be rigorously evaluated by the PI’s department before an expedited or full review application is submitted to the Stanford IRB. 

CRU reviews are coordinated by Kendall Seigworth, MPH (kseig@stanford.edu), the department’s Regulatory Specialist and CRU Lead. She collaborates closely with faculty, trainees, administrators, and skilled research staff to facilitate study planning and initiation. 

Please consult our OB/GYN CRU Review Decision Tree or contact kseig@stanford.edu to help you determine if your proposed study requires CRU review.

Research Support Intake Form
Download PDF of CRU Decision Tree

OB/GYN CRU review is a two-part process consisting of: 

  1. Scientific and Scholarly Validity Review
  2. Financial and Operational Feasibility Review

Please be advised that CRU review takes a minimum of two weeks (10 business days) to complete. The earlier you submit your study protocol, budget details or draft, and CRU Protocol Intake Form to the OB/GYN Research Support Form, the better prepared we are to provide you with a quality review process in time for your grant and IRB submission deadlines! This review process aligns with our mission to improve women’s health through innovative care, education, advocacy, and research.

For more information about the two-part CRU review process, please see our ‘What is OB/GYN CRU Review?’ Fact Sheet.

1. What is OB/GYN CRU review?

The OB/GYN department’s internal review of any prospective research requiring IRB submission. The purpose is to 1) fulfill IRB’s requirement for ‘Scientific and Scholarly Validity’ review and 2) to assure the financial and operational feasibility of the planned research.

  • The IRB will not review studies with pending or internal funding without our department’s CRU approval. 

2. How long does it take?

CRU review by a faculty peer-reviewer and department administration takes a minimum of 2 weeks (10 business days). The earlier the submission, the better.

  • Example: if you have a grant deadline due October 14, you will want to submit for CRU review no later than September 30.

3. What documents are needed for CRU review?

  1. The CRU Protocol Intake Form: Please fill this out to the best of your ability.
  2. IRB submission draft or another draft that outlines the protocol.

  • Please download and/or add Kendall Seigworth (SUNet: kseig) to your eProtocol.

4. How do I submit to the CRU?

  • CRU review requests are sent via OB/GYN Research Support Form or emailed directly to kseig@stanford.edu. Once CRU review is complete, you will be provided with a CRU approval letter to attach to your IRB submission. 

5. I still have questions about the CRU review and IRB submission process. What should I do next?

Please reach out to Kendall Seigworth at kseig@stanford.edu! She is available for 1:1 meetings, as well as meetings with our Grant Writers, Research Administrators, and clinical research staff to discuss appropriate next steps for your study.