Clinical Research Support Office/CRSO
C. Reduction And Removal Of Institutional Impediments
The third goal of the CRSO is to reduce or remove institutional impediments to clinical and translational research. The Rockefeller University Hospital Information Technology Strategic Plan, drafted in 2003, identified from its outset the need for streamlined workflow in the conduct of clinical research. The Clinical Research Support Office is operationally linked to the Bioinformatics Department and the fulfillment of the Center Information Technology (IT) Strategic Plan, on which the Clinical Research Officer has collaborated from its conception. This collaboration has been crucial, as the promise of data integration, transparency, and workflow assistance integral to the IT Plan are crucial to the dissemination of commonly utilized protocol information, critical regulatory and safety information, the reduction of duplication of effort, and the removal of obstacles to the conduct of translational clinical research, all of which are critical to the success of the clinical research enterprise.
The CRSO contributes content experts, as do many departments, to the implementation of the interdisciplinary Protocol Navigation Program, led by the Clinical and Translational Research Facilitation Office. This program has reduced multiple impediments to research, especially for non-clinician scientists, while enhancing GCP and participant safety.
The iRIS electronic platform integrates the functions of a clinical research management system including Admission/Discharge/Transfer and Scheduling functionalities; customized on-line Protocol writing and Submission; IRB Database and workflow; Protocol Document Management; Adverse Reporting; Case Report Form generation; and Study Management, including protocol clinical pathways mapping and data capture. Efficient research development and conduct requires close institutional coordination of activities across offices and functions, including the IRB, the Research Pharmacy, Medical Staff Credentialing, patient care services, Nursing, Sponsored Programs, Bioinformatics, Conflict of Interest management, Research Facilitation, the Clinical Research Support Office, and other departments, to share data, expedite processes, reduce duplication and error, and assure research integrity and patient safety. The Clinical Research Officer seeks continually to harmonize and integrate process and policy across the many departments and elements of infrastructure at the hospital and CCTS.