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.
Services We Provide
CPDM offers a complete range of clinical research services that support our Cancer Center members, including:
- Clinical research support staff (nurses and coordinators)
- Data management resources
- Regulatory assistance
- Centralized patient registrar
- Quality assurance monitoring
- Budget development and financial management
Overview of Our Capabilities
CPDM is proficient in several activities that support the services provided, including:
- Managing Pilot, Phase I, II and III clinical trial protocols across the protocol life cycle.
- Assisting with recruitment to clinical trials.
- Designing and maintaining study database information and web-based research tools.
- Providing multi-level monitoring for research data, quality assurance, clinical trial accrual, and adverse events.
- Providing regulatory support to maintain compliance with all internal and external regulatory requirements.
- Procuring and storing clinical specimens (body tissue) for participants in clinical trials.
- Providing remuneration to participants in clinical trials (as appropriate).
- Managing participant follow-up visits.
- Providing study visit scheduling, data entry and tracking of participants.
- Providing technical and writing assistance for developing protocols.