CORE--CLINICAL TRIALS AND PROTOCOL REVIEW AND MONITORING SYSTEM

Ohio State University, Columbus OH

Investigators

Linked publications & trials

Abstract

The CCC Clinical Trials Office [CTO] supports the centralized administration of protocol development, review, implementation, monitoring, regulatory compliance, and quality assurance. The CTO was established in September 1998 by consolidating resources of the Interdisciplinary Oncology Unit, the Ambulatory Oncology Unit, and the Office for Quality Assurance for Clinical Trials. Rebecca Jackson, M.D. was named CTO Director and five full-time staff members [2 research nurses, 2 protocol compliance staff, and a secretary] were initially appointed using a combination of CCSG and institutional funding. The CTO coordinates the efforts of 25 additional interactive clinical trials staff funded by cooperative group contracts, grants, and institutional funds. The CTO initially reviewed existing clinical research policies and procedures and developed formal standard operating procedures for the conduct of all clinical trials at the CCC. The protocol review process was strengthened by reorganizing the Clinical Scientific Review Committee [CSRC] and formalizing review criteria. The CTO assists investigators in developing new studies by informing them of the protocol review process, by providing protocol outlines and templates, and by referring investigators to collaborators with appropriate expertise. The CTO helps the investigators through the review processes of the CSRC and IRB by preparing protocol submission documents and consent forms. Following protocol approval and implementation, the CTO maintains all study regulatory documents in a central location, distributes protocols to interested investigators, and supports a Clinical Research Information System which allows centralized protocol registration and report generation. CTO staff also screen patients for trial eligibility to increase the proportion of patients registered on clinical trials. The CTO prepares protocol performance reports for the CSRC in support of monitoring the scientific progress of all studies. Protocol compliance staff of the CTO conduct a formal audit program using random selection of studies and patients to review protocol compliance and data accuracy. Educational programs developed and conducted by the CTO train clinical and data management staff in the proper application of Good Clinical Practices. The quest for CCSG support for 2.6 FTE for the CTO represents support of 8.7% of the total CTO effort in centrally managing CCC clinical trials.