CLINICAL RESEARCH OFFICE

Johns Hopkins University, Baltimore MD

Investigators

Linked publications, trials & patents

Abstract

The Clinical Research Office (CRO) provides numerous services to faculty and staff conducting oncology research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The CRO has a key leadership role in the SKCCC research infrastructure, with the CRO Director overseeing and integrating activities among the several Clinical Research Cores. The Program Managers of the seven disease-specific research Programs and the SAC lab Manager have a dual-reporting relationship to both the Research Program Directors and the CRO Manager. This allows for a centralized research infrastructure yet at the same time allows disease-specific Programs flexibility based on the disease(s) being studies. Centralized and integrated CRO electronic resources include (1) a Clinical Research Management System (CRMS) tracking real time accrual to all oncology research studies, (2) a Protocol Library containing all active protocols, consents, order sets, and related documents, (3) a Pharmacy Research Orders Tracking/Approval System (POTS), (4) the Protocol Review and Monitoring System-Clinical Research Review Committee (PRMSCRC) Electronic Forum tracking documents, scientific review comments, and meeting outcomes from the weekly pre-PRMS-CRC (pre-Protocol Review and Monitoring System) and CRC (Protocol Review and Monitoring System) meetings, (5) a Standard Operating Procedures website for housing recommended clinical research methods and procedures, (6) a Regulatory Documents Warehouse to provide centralized access to common regulatory documents including clinical investigator CVs and laboratory certifications, and (7) an external SKCCC Clinical Trials website to facilitate web-based clinical trials searches by the community. Education provided by the CRO includes an introductory research course for all new research staff involved in oncology clinical trials, CRMS training, and continuing research education for research faculty and staff. The CRO provides regulatory expertise regarding FDA regulations and Investigational New Drug (IND) submissions, and internal regulatory oversight and guidance for all investigator-initiated trials. Quality assurance services are an essential component of the CRO via auditing and monitoring and developing standard operating procedures. The CRO acts as a liaison with the Johns Hopkins Institutional Review Boards, outside auditors and regulatory agencies. In 2010, there were 499 active research studies, including 319 therapeutic (354 Intervention) clinical trials. Accruals in 2010 totaled 6,386; including 5,036 to non-intervention studies and 1,350 to intervention trials. Lay: The Clinical Research Office (CRO) provides a centralized infrastructure for the conduct of clinical trials, including formal education programs, regulatory expertise, auditing, and databases such as a Protocol Library; a Clinical Research Management System (CRMS) for tracking enrollment, and a Pharmacy Orders Tracking System (POTS). The CRO plays a key role in integrating activities among the other clinical research cores. SKCCC Managed Shared Resource Current Grant Year Reporting Period: January 1, 2010 to December 31, 2010.