Clinical Protocol Office
Bert O'Neil, MD, Medical Director
Wendy Sarratt, DrPH, Administrative Director
Kim Keller, RN, MSN, OCN, Clinical Director
Brian Kiley, MBA, Finance Director
Mary O'Dwyer, MRP, CCRP, Regulatory Director
The Clinical Protocol Office (CPO) consists of 75 healthcare professionals supporting the design and conduct of oncology clinical trials. The CPO is responsible for patient and study coordination-related activities; including subject evaluation and registration, toxicity assessment and safety monitoring of novel therapeutics and patient education. The CPO assists and facilitates protocol development, contract acquisition and management, regulatory oversight and compliance, preparation and submission of INDs for novel studies and novel compounds, internal and external study audits, quality control, and data acquisition, transcription and management. The CPO works with the Protocol Office Executive Committee (POEC), the Data Safety Monitoring Committee (DSMC), the Oncology Protocol Audit Committee (OPAC), and the Protocol Review Committee (PRC) to assure patient eligibility and safety, regulatory compliance and quality, reproducible data.
Third floor, UNC Lineberger Comprehensive Cancer Center
Monday - Friday, 8:30 a.m. - 5:00 p.m.
- Oncology Research Nurse Clinicians
- Clinical Research Associates
- Regulatory Associates
- Financial Staff
- Protocol Development Associates
For More Information
For questions regarding the Protocol Review Committee (PRC), the Data and Safety Monitoring Committee (DSMC), or the Oncology Protocol Audit Committee (OPAC), call Micah T. Sam, BA, PRC Coordinator at 919.843.6901 or by email .