We provide expertise and guidance on completion of a variety of research forms and regulatory documents required when implementing a clinical study.

Regulatory consultations are available to guide and support you as you design protocols, navigate through the approval process, and conduct your research.

Services include:

• IRB application guidance and review
• Guidance responding to IRB contingencies
• Consent process guidance

For assistance completing IRB applications, please contact the RCMU.

For assistance with IND and IDE submissions, please contact the Clinical Research Compliance Office.

For assistance with a Data Safety Monitoring, please contact One UNC Clinical Research.