Clinical Protocol and Data Management

Johns Hopkins University, Baltimore MD

Investigators

Linked publications, trials & patents

Abstract

ABSTRACT The Clinical Protocol and Data Management (CPDM) is the central home for numerous services to faculty and staff members conducting research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The CPDM has a key leadership role in the SKCCC infrastructure and, in conjunction with the Associate Director of Clinical Research, oversees all clinical research conducted in the SKCCC, developing, implementing and enforcing SKCCC and institutional research standards. The Clinical Research Managers of each Clinical Research Group (CRG) have a reporting relationship to the CRG Directors and the CPDM Manager, supporting a centralized infrastructure while bolstering flexibility within each disease group. The CPDM developed, implemented, and currently oversees and maintains several electronic resources available to the SKCCC, including CRMS, the centralized repository for all clinical trial data. It led the way in integrating these systems with existing and developing institutional systems, allowing efficient flow of protocol-related data. The CPDM provides education and training, which includes cultural competency, CRMS training and individual, hands-on training for new coordinators and nurses based on CRG needs. The CPDM provides regulatory expertise regarding FDA regulations and Investigational New Drug (IND) submissions, internal regulatory oversight and guidance, and protocol development support for all investigator-initiated trials. The CPDM supports both the Protocol Review and Monitoring System (PRMS) and the Data Safety Monitoring Committee (DSMC), though this support is administrative in nature, and both committees are independent and distinct bodies. Quality assurance services are an essential component of the CPDM via auditing, monitoring, developing and maintaining standard operating procedures. Staff members facilitate eIRB submissions, provide the final activation for studies, and act as liaisons with the Johns Hopkins Institutional Review Boards, outside auditors and regulatory agencies. The CPDM also supports and maintains the SKCCC Coordinating Center, which provides multisite regulatory and data support, site initiation services, and manages all Phase II trials conducted under the Experimental Therapeutics Clinical Trial Network (ETCTN) grant. The Inclusion of Women and Minorities in SKCCC clinical trials is a major focus of leadership and faculty members, and important steps have been taken to advance this effort, including the formation of the SKCCC Office of Community Cancer Research. This group focuses on external community outreach and the internal evaluation of SKCCC recruitment and retention practices to improve clinical trial participation. Mandatory cultural competency training was implemented across the SKCCC to improve awareness among providers and staff members. The Assistant Director for Diversity and Inclusion works with and is supported by the CPDM to collect and analyze accrual data, develop SOPs to improve accrual, and promote cultural sensitivity in recruitment and retention practices. The SKCCC plays an important role in the community and regionally in its commitment to the treatment of Children with cancer, using the most current therapies available. This commitment is apparent in the substantial participation in national NCI trials and in the numerous investigator- initiated studies conducted here.