UCSF Clinical Research Infrastructure Action Plan

The recommendations came from two sources:

• the Clinical Research Infrastructure Taskforce which issued its report in December 2010
• the Decade of Human Biology Taskforce on Clinical and Translational Research at the end of January 2011 
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Initiatives that will debut this summer and fall:  1. Electronic Clinical Research Management System: OnCore: “Online Collaborative Research Environment, the Forte Research Systems’ Enterprise-Class suite of Clinical and Translational Research Informatics software products UCSF-wide.   This gives UCSF's clinical researchers access to  the Clinical Research Model - CRM but also to the OnCore system for Biospecimen Management (OnCore-BSM) and the OnCore system for Unified Registries Management (OnCore-URM).   OnCore is currently deployed in the School of Dentistry and the Comprehensive Cancer Center under the leadership of Sorena Nadaf, Director of Translational Informatics.  Sorena will oversee an expanded Clinical Research Informatics Support Services (CRISS) team that will be able to serve the entire campus. Initial funding for the expansion of TI-CRISS, including these new positions as well as the necessary additional licenses comes from CTSI and the Office of Research.  The long-term funding model for this initiative is under development.  The initiative is following a phased OnCore expansion approach in order to gain further experience with the multi-disciplinary version of the CRM and to ensure that faculty and staff receive the appropriate training to get the most use from the system.  The Diabetes Center, the Airway Clinical Research Center, Department of Neurology, and the Clinical and Translational Sciences Institute (CTSI) have begun participating as early adopters.   These four groups will be participating in training sessions scheduled to begin in early August.    2. Create a virtual Clinical Research Resource HUB The HUB will provide a single portal of resources, expertise, and best practices for investigators and research staff to facilitate efficient, compliant and ethical study conduct and management.  This is a collaborative effort across a number of organizations and administrative units to leverage existing resources as well as create new content where currently no readily accessible resources exist.  The support for this project is a combined effort between the Office of Ethics and Compliance (Elizabeth Boyd), CTSI Clinical Research Services (Bill Balke), and the Office of Research (Susanne Hildebrand-Zanki).  The goals of creating the HUB are to:

• Promote excellence in quality of clinical research management through education.
• Facilitate effective and timely clinical research initiation by improving institutional processes and providing clinical research protocol, regulatory, budget, and finance tools.
• Increase awareness of clinical trials in the community through education and community participant recruitment outreach activities.
• Interface with institutional/industry partners to support enhanced clinical research practice.