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Clinical and Translational Science Center

Clinical and Translational Science Center

CLINICAL TRIAL RESOURCES

Clinical Trial Resources has undertaken the goal of transforming the clinical research enterprise into a more integrated structure. In addition to facilitating compliance with clinical trials regulations (including IRB, FDA and Medicare), the group is a catalyst for reorganization of the institutional functions necessary for the next generation of clinical research. This unit also facilitates multiple workgroups aimed at improving the clinical research process flow and operations.

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Services We Offer

Regulatory Compliance.

We support investigators, the IRB, and the Office of Research Compliance and Integrity (RCI) by providing training and consulting services.

  • Good Clinical Practice (GCP) Education – Support of CITI training by providing in depth training on implementation of GCP principles at UC Davis.
  • Investigator Training – On-site regulatory start-up training for investigator-initiated studies.
  • Complete Study Start-up – Analysis of protocol, preparation and negotiation of budgets, development of coverage analysis, and preparation of IRB documents and study logistics up to the site initiation visit.
  • Preparation of IRB documentation – Support for individual projects as requested.
  • Coordinator for Hire - Support for individual projects.
  • Coordinator Oversight - Guidance of department coordinators to ensure study excellence.
  • Coordinator Mentoring - Counseling of new Department coordinators to identify and fill knowledge/experience gaps per CTSC SOP#3
  • Study Monitoring – Support for individual projects.
  • Internal Audits – Assistance with resolving RCI findings on projects.
  • FDA audits – Preparation for the FDA audits.
  • IND/IDE – Provision of tools, training, information or support.
  • ClinicalTrials.gov – Assistance with opening accounts for individual researchers; education on principles of ClinicalTrials.gov.

Clinical Research Billing (CRB).

We stay abreast of new regulations in this area and continuously incorporate these changes into training materials and tools. We create tools, templates, quality training materials, and provide consulting on processes that involve clinical research billing. We provide Coverage Analysis support for individual studies, as requested. • CRB Education – Training in the form of workshops and materials on the web.

  • Coverage Analysis Document Preparation – Support for individual projects as requested.
  • CRB Process Improvement – Participation in technical implementation of Health System Compliance requirements (i.e., Bridge, EMR research functionalities) by guiding IT with accurate information to develop solutions. Clinical Research Process Improvement. We create training and tools (i.e., Clinical Research Guidebook, Process Maps and SOPs) to guide researchers through the clinical research process at UC Davis. We generate metrics for evaluation of the process for decision-making by the Dean’s Office. We provide Lean consulting on selected projects; however, it is a Department responsibility to implement and oversee the improvements suggested by the CTSC Lean consultants.

Training and Education Resources

Clinical Research Coordination (CRC) Courses

CRC 1.0-Introductory course
This course is specifically designed for department administrators, staff and physicians who may not be directly involved in clinical research or are just beginning their clinical research career. The course highlights the main elements of the clinical trials process at UC Davis Health System.

CRC 2.0- Basic course
Designed for investigators and staff who wish to improve their competency in the field of clinical research management, this course prepares participants to coordinate clinical research projects from study initiation to close out in compliance with Good Clinical Practice (GCP) Guidelines.

CRC 3.0- Advanced course
Created for investigators and coordinators who manage multiple complex trials, this advanced course is offered at least once a year. This one-day course focuses on in-depth topics, which are presented in an alternating lecture and breakout format.

Clinical Trials Brown Bag Series
Monthly Brown Bags provide an overview of new and existing developments in clinical research around the world.

Training Archives
Training materials from prior years are available via this web-based archive.

Investigators and Study Teams

Access to the main Clinical Trial Resource website that provides information for research teams.

Patients and Volunteers

We assist members of the community with finding ways to engage with clinical research opportunities.

Clinical Trials at UC Davis
Breakthroughs that address the health challenges facing our world are at the core of our mission to discover and share knowledge to advance health. UC Davis conducts more than 1,000 research studies annually, including basic science, translational and clinical trial research — all with the goal of bringing new, effective and safe treatments to patients more quickly.

Frequently Asked Questions

Find a Clinical Trial

Join the Research Volunteer Registry

Access the Patient and Volunteer website

Industry Sponsors

We provide connections with clinical research expertise on campus and offer partnership management to ensure rapid start up of clinical trials. For more information, please contact:

Kate Marusina, Ph.D.
Manager
kate.marusina@ucdmc.ucdavis.edu
(916) 703-9177

Other Resources

Clinical Research Guidebook
This compendium of UC Davis processes and administrative procedures is available in a printed format or online. The Guidebook follows clinical research process maps and provides step-by-step assistance in an easy-to-follow, at-a-glance format. A supplemental checklist bridges the Guidebook and process maps to serve as a tool for those who wish to track their process through a study. This resource is highly recommended for all members of the research team.

Clinical Trial Blog
This online forum provides space for clinical research coordinators to share, learn, and improve clinical research at UC Davis. Post questions, comments, news and reflections about clinical research.

Clinical Trial Listserv
Stay current with information related to clinical trial training opportunities, updates and events by joining our listserv. E-mail Elizabeth Mathis to be added to the listserv.

Newsletters
The newsletters provide monthly updates related to procedural changes in the clinical trials administrative process. The newsletters also contain clinical trials announcements, recent events and upcoming training and education seminars. E-mail Elizabeth Mathis to be added to the newsletter distribution.

Process Maps
These interactive diagrams will guide research teams through the steps (required and recommended) for interventional, non-interventional, and behavioral studies. They depict, in detail, the flow of research processes at UC Davis. These maps are closely linked with the Guidebook and enable study teams to navigate the administrative landscape at UC Davis.

SOPs
These documents are an invaluable resource for best practices in the conduct of clinical trials at UC Davis Health System.

Study Management Tools
Online access to helpful documents for study management. Feel free to use them as is or modify for your specific purposes.

Did you know...

  • Clinical Trials webpage had over 1000 visits in 2013-2014 FY.
  • Clinical Trials Group has track record of 100% success of IND approvals.
  • Over 700 people attended the Clinical Trials Group education and training programs.