Clinical Protocol Office

Room: Third Floor Administrative Wing, UNC Lineberger
Director(s): Joy Ostroff, RN, BSN, OCN®, Facility Director

Hours: M-F 8:30 a.m.- 5:00 p.m. Eastern Time
Phone: (919) 966-4432
Fax: (919) 962-2621
Email: Joy_Ostroff@med.unc.edu

Services:
The Clinical Protocol Office (CPO) consists of 48 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.

Staff:
The staff includes Oncology Research Nurse Clinicians, Clinical Research Associates, Regulatory Associates, Research Technicians, Financial Officers, and Administrative Assistants. The Medical Director is Claire Dees, MD, a faculty member in medical oncology, and the Facility Director is Joy Ostroff, RN, BSN, OCN®.

Location:
The Clinical Protocol Office is located on the third floor of the Administrative Wing of UNC Lineberger Comprehensive Cancer Center. The Office is open Monday through Friday from 8:30 a.m to 5:00 p.m.

For More Information:

Visit the Clinical Protocol Office or telephone 966-4432 or toll free 1-877-668-0683.
For more information about the PRC, DSMC, or OPAC, please contact Micah T. Sam, BA, PRC Coordinator at (919) 843-6901 or msam@med.unc.edu.

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