Clinical Protocol and Data Management (CPDM) provides support for the infrastructural elements of clinical research, including finance, regulatory, data, and nursing management to promote Wake Forest Baptist Comprehensive Care Center (WFBCCC) science and translation and promulgate National Cancer Institute (NCI) and Cancer Center Support Grant objectives in clinical research operations.
CPDM provides a broad range of management and quality control functions, including:
- Trial activation and monitoring
- A centralized protocol document directory
- A centralized database of protocol-specific data
- Data and safety monitoring activities that promote study participant safety
- Assistance with complex regulatory issues
CPDM further provides high-quality services involving assistance with patient enrollment, screening, obtaining informed consent, and safety reporting.
The specific aims of CPDM are to:
- Provide key leadership and core staff to centrally manage and facilitate clinical trials that prioritize patient safety and optimize the participation of underserved populations at the WFBCCC.
- Provide regulatory and data management, reporting and quality assurance of clinical trials conducted at the WFBCCC.
- Provide protocol coordination throughout the trial lifecycle for trials conducted at the WFBCCC.