The Rockefeller University: July 2008
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Rockefeller University's Center for Clinical and Translational Science In its first 18 months, Rockefeller University's Center for Clinical and Translational Science (CCTS) has made substantial progress in many areas, including the support of clinical research, the initiation of novel translational science research, the development of teaching programs aimed at community physicians, the institution of Good Clinical Practice (GCP) for all research protocols, and the support of the national recognition and certification of clinical research nursing. Notably, two CCTS efforts may be models for the CTSA Consortium: (1) electronic programs that facilitate study tracking, scheduling, and reporting and (2) an Advisory Committee for Clinical and Translational Science (ACCTS) that expands on the roles of previous committees and serves as the primary protocol reviewer and governance structure for the CCTS. Through its Integrated Research Information System (iRIS), Rockefeller's CCTS offers Study Assistant and Review Board Assistant, both of which are in the final stages of development. Study Assistant is an electronic study management module that enables study personnel to generate inclusion/exclusion criteria checklists, order sheets, and worksheets for each protocol-specific study visit as well as to schedule participant visits. The program records visits, tasks and procedures in the iRIS database, thus providing documentation that meets all GCP and audit requirements. Review Board Assistant permits electronic production and distribution of protocols to both the ACCTS and the institutional review board (IRB) and creates the underlying board databases. Committee and board members review and sign documents electronically. Approximately 75% of the participants in Rockefeller's Outpatient Research Center studies were integrated into iRIS between September 2007 and March 2008, in a testing phase. Since then, investigators and reviewers have begun testing the iRIS system to submit protocols for ACCTS and IRB review. Once researchers and staff are fully trained in using iRIS and protocols have been managed in iRIS for a year, a large portion of the annual progress reports to the IRB will be automatically generated through iRIS's databases, including the number of screened, enrolled, and completed participants (including their ethnicities and racial statistics) and adverse events. This system will save time while it ensures consistency and accuracy. The ACCTS continues the function of the General Clinical Research Center advisory committee by providing assessment of all new protocols for scientific excellence before review by the IRB. However, the ACCTS also reviews the design, statistical plan, provisions for human subjects protection, regulatory issues, compliance with GCP, use of core resources, resource requirements, staff training requirements, and appropriateness of data safety and monitoring plans. The ACCTS promotes efficiency in review by meeting at least monthly and by performing all key function tasks in parallel, rather than sequentially. The ACCTS also sets priorities for the use of CCTS resources; it ensures compliance with NIH policies; supports strategic planning for the CCTS; contributes to an annual written assessment of the educational programs, bioinformatics, biostatistics, nursing, bionutrition, and pharmacy for internal and external review; and participates in the internal evaluation process. It will help recruit new faculty and clinical scholars, identify potential new collaborative opportunities and translational programs, advise on the budget process, identify barriers to translational and clinical research, ensure compliance with GCP, recommend novel methodologies for core support, and create metrics to assess the strengths and weaknesses of the CCTS. Reports of these functions and numerous other activities are captured in an e-newsletter developed under the direction of Primary Investigator Barry Coller. For access to the e-newsletter and other information, please visit Rockefeller University's CCTS Web site. |