Research

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. In 2008, a site-based research organization was created to ensure that these trials are ethically and efficiently managed with the ultimate goal of improving the overall quality of the patient care experience and providing the highest quality clinical research environment possible.

Under this site-based research organization, each academic department or therapeutic area 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 specific 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 and Key Forms for all pediatric clinical research investigators have been developed and are available here to download.

Clinical Trials

Duke University Medical Center has established a clinical trials network to ensure that patients have access to cutting edge medicines and therapies. Clinical trials take place under the most stringent guidelines, and participants benefit from closely supervised care.

To find current clinical trials, browse the list or select a category from the drop-down menu on dukehealth.org.

To learn more about participating in clinical trials at Duke, please visit Clinical Trials Information for the Public and Study Subjects .

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 web site for guidance on how to complete the form.