The Office of Research Administration (ORA) is a vital Shared Resource of the Cancer Therapy and Research Center (CTRC) at The University of Texas Health Science Center at San Antonio (UTHSCSA; termed CTRC). The ORA allows centralizafion of protocol and data management funcfions, a crifical need for CTRC's successful operafion due both to the increasingly complex nature of clinical research and the need to ensure opfimal integration with UTHSCSA ethics and regulatory bodies. In order to ensure the highest level of patient safety and research quality, the ORA supports both the Data Safety and Monitoring Committee (DSMC) and Protocol Review Committee (PRC). The DSMC is charged with the responsibility for monitoring, reviewing, and taking administrafive acfion as needed on all active CTRC studies. All studies are monitored unfil every patient has completed treatment and follow-up on study. The DSMC oversees all aspects of research data validity and integrity, ensures regulatory compliance, and protects the safety of participants in all CTRC clinical studies. The PRC function is to review, prior to UTHSCSA Institufional Review Board (IRB) submission, all clinical CTRC studies for scientific merit and to ensure appropriate prioritizafion in terms of accrual and Shared Resource ufilizafion. The ORA provides centralized support for all CTRC invesfigators including, but not limited to, protocol development, centralized data collecfion and disseminafion of protocol information with supporting documents, registration of pafients onto approved clinical trials following confirmafion of pafient eligibility, and assistance in data analysis. The ORA serves as an interface with the IRB to facilitate preparation of the required consent and HIPAA forms, and other regulatory documents necessary to expedite effective review and opening of cancer center protocols. The ORA is comprised of five divisions: Regulatory Affairs, Contracts and Budgets, Clinical Invesfigations, Pafient Referral, and Quality Assurance. These groups are highly integrated to ensure compliance, standardization, institufion-wide involvement in quality assurance processes, accurate and rapid patient enrollment, fiscal responsibility, and a funcfional collegial non-duplicative interface with the relevant UTHSCSA bodies. The ORA works closely with the Biostafisfics and Informafics Shared Resource which is responsible for the design, implementafion and maintenance of the Informatics Data Exchange and Acquisifion System (IDEAS) database. DEAS is used to monitor data quality metrics, protocol compliance, enrollment rates, to identify data entry issues, to and to generate queries. ORA acfivifies have resulted in a consistenfiy high level of accrual to clinical trials during this grant period with excellent reports on numerous audits from sponsors and the NCI. The ORA Director reports to Dr. Giles, the CTRC Deputy Director.
The ORA's relevance to CTRC research is its pivotal role in ensuring the highest levels possible of both patient safety and quality of research conducted in the cancer center. The ORA is vital to the submission and implementation of research studies associated with P30 programs. By providing these centralized services, investigators are able to concentrate on research conduct and patient care which, when combined with ORA and support, allows both to be optimal.
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