Research Oversight and Compliance Core

faculty discussing research with students The Research Oversight and Compliance Core is responsible for reviewing new protocols and research data security plans; liaisons with ancillary departments (i.e. Office of Research Contracts, Research Support Offices, Duke Office of Clinical Research, Duke Health Information Security Office, DUHS IRB, etc.) to facilitate required contracts and agreements in support of research protocols; is home to the IRB Preparation Laboratory; provides assistance with study implementation, including compliance education; and consists of two Research Practice Specialists and grant supported research personnel.

Activities

IRB Process Support
IRB Review
Grant Supported Research Staff
Education Support

The Research Oversight and Compliance Core (ROCC) is committed to maintaining the highest standards of research integrity by promoting ethical practices and ensuring that all research activities comply with regulatory requirements and institutional policies.

In partnership with the faculty CRU Director, the ROCC group comprises the Research Practice Manager, Assistant Research Practice Manager, Senior Clinical Research Coordinator, and grant supported research staff, including Clinical Research Specialists, Clinical Research Coordinators, and Research Program Leaders.

Activities and Support Services

IRB process support
IRB submission review
Study start up
Hiring and onboarding of research staff
Research compliance guidance
Review and approval of Duke Research Data Lifecycle plans
Quality Management Review as part of the Clinical Quality Management Program
Research agreement support (data sharing, materials transfer, transcription, reliance agreements)
ClinCard and other research participant payment support
Training and Support (i.e., Responsible Conduct of Research, CITI)