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) including centralized systems, education, regulatory expertise and quality assurance. Centralized systems are all easily accessible via the CRO website. These systems include an up-to-date protocol library with all approved protocols and consents, a database of all oncology research studies including study accrual and tracking of all IRB submissions, the Clinical Research Review Committee (CRC) Electronic Forum which tracks documents and meeting outcome to support the CRC, a research manual with Standard Operating Procedures, and a pharmacy orders review system for tracking pre-approved orders. Education provided by the CRO includes an introductory research course for all new research staff conducting oncology trials, continuing research education for research faculty and staff, and the "Messenger" newsletter designed to keep research personnel up-to-date with policies and regulations. The CRO provides regulatory expertise in the area of FDA regulations and Investigational New Drug (IND) submissions, and oversight and guidance for all investigator-initiated, multi-site trials. Quality assurance services are an essential component of the CRO via auditing and monitoring, reviewing adverse events, and developing standard operating procedures. Other services offered to investigators include acting as a liaison with the Johns Hopkins Institutional Review Boards, outside auditors, and the SKCCC External Clinical Trials website manager (to promote open trials to the community). Each SKCCC research Program has a Program manager who has a dual reporting role to both the Research Program Directors and the CRO Manager. In 2004, the CRO received 2,401 submissions (new studies, amendments, SAEs, etc). There were 348 active studies in 2004, 76% intervention in nature. This represents a heavy load in an intense regulatory environment where there i increased scrutiny and continuous interactions with the IRB. Accruals in 2004 equaled 3,121; 72% on nonintervention studies and 28% on intervention trials.