Pediatric Site-Based Research Unit (SBRU)

Overview of Site-Based Research at Duke

Each year, more than 1,000 faculty and study coordinators at Duke enroll patients in clinical trials that involve medical treatment. Recently, a site-based research organization was created to ensure that these trials are ethically and efficiently managed, which will ultimately improve the overall quality of the patient care experience and provide the highest quality clinical research environment possible.

Under the new site-based research organization, each academic department or therapeutic area has established--in conjunction with the Clinical Research Support Office (CRSO)--a site-based research (SBR) group or unit to oversee all clinical research that involves medical care in that area. The Department of Pediatrics has its own group, the Pediatric Site-based Research Unit (SBRU).

Each SBR has certain key components including:

Faculty members in a particular therapeutic area who are enrolling Duke patients in clinical research studies that involve medical care

Study coordinators and research staff who are specifically aligned with this faculty group

A faculty advisory board

A director (usually a faculty member)

A lead study coordinator

A financial manager

However, because of the diverse nature of research at Duke, departments have defined individual operating models that work most effectively in their respective areas. To ensure consistency and clarity of responsibilities and procedures within the Department of Pediatrics, a Manual of Operations for all pediatric clinical research investigators has been developed and is available here to download.

eIRB News

UPIRTSO Reporting

Please note new IRB information regarding UPIRTSO reporting. This information is posted on the eIRB home page:

08-07-2008 -- New Prompt Reporting (formerly UPIRTSO) Form
The Prompt Reporting (formerly UPIRTSO) form is to be used as you conduct your research study whenever you encounter a problem or event that is both unanticipated and indicates that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. See the Forms section of the DUHS IRB Website http: http://irb.mc.duke.edu for Guidance on how to complete the form.