Clinical Trials Office

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The Clinical Trials Office Core (CTO) provides comprehensive clinical trials resources and support to KCI members and affiliate institutions with the highest priority being the safety of participating subjects. The CTO functions to the highest ethical standards ensuring and maintaining compliance of KCI ciinicai trials with internal policies and external governing bodies. The primary and continuing goals ofthe CTO are to: ¿ Ensure that all clinical trials conducted at KCI are carried out in strict compliance with the Code of Federal Regulations (CFR) and in accordance with Intemationai Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. This is done in conjunction and with oversight by the Wayne State University Human Investigation Committee. ¿ Facilitate and optimize accrual to clinical trials by providing well qualified, specifically trained data management and research nurse support to KCI physicians and clinical support staff. ¿ Ensure research coordination by facilitating and optimizing physician-patient-CTO staff interaction, communication and collaboration. ¿ Facilitate regulatory approval and oversight to rapidly review and activate appropriate trials. The CTO coordinates and ensures compliance with the Data and Safety Monitoring Plan (DSMP), which irilSlu'des coordination and administrative support to the Protocol Review and Monitoring Committee, the Data and Safety Monitoring Committee and the Quality Assurance Committee. Additionally, the CTO serves as an interface with the protocol specific IRB of record to facilitate preparation of required regulatory documents necessary to expedite timely approval of KCI protocols. The CTO also coordinates registration and maintenance of all therapeutic protocols to the NCI's Clinical Trial Reporting Program and ClinicalTrials.gov. CTO supports NCI-funded peer reviewed protocols, investigator-initiated studies, industry sponsored protocols and the cooperative group protocols of SWOG, COG, GOG, RTOG, as well as other specialty cooperative groups. Over 80 FTEs provide data management services as members of the CTO in support of approximately 350 active protocols. These activities have resulted in a 76% increase in accrual to therapeutic clinical trials during this grant period with representation of minorities and women that reflect the communitv that KCI serves.