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.

 

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

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Services We Offer

Package Plans:

Complete Study Management
Management of your entire clinical trial, from beginning to end.

Study Start-up
Includes all start-up activities, such as budget preparation and negotiation, IRB and contract support, logistics, and other approvals as needed. The approved study is transferred to the department at the site initiation visit.

Individual Services:

Clinical Trial Consultation
A no-cost, preliminary discussion to determine the scope and needs of a specific project.

Clinical Research Coordinators (CRCs)
The CRC Pool provides trained and credentialed CRCs for short-term projects. Services include data management, query resolution, assistance with regulatory paperwork, study start-up and close-out, and patient enrollment.

IRB Preparation and Review
Preparation or review of IRB applications, modification requests, or annual reports.

FDA Application (IND/IDE)
Preparation and submission of Investigational New Drug/Device application, amendments, exemptions, annual and safety reports. Maintenance of communication with FDA.

Monitoring and Quality Assurance
Assistance with monitoring and quality assurance of investigator-initiated and industry-initiated trials. We help to ensure compliance with FDA, GCP, and IRB regulations, as well as with UC Davis Health System SOPs and P&Ps regarding clinical research. We aim to provide proactive and educational (rather than “for cause”) regulatory and data quality assessment.

Coverage Analysis
Development of billing grids for protocols, consultation on EMR research functionality, and assistance with research billing questions. In-service training options include: developing coverage analysis; explanation of routine costs and services not billable in a trial; use of tools available on the CTSC website for developing billing grids; and guidance on the existing policies and procedures related to clinical trials billing.

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 (Staff Only)
Training materials from prior years are available via this web-based archive.

Investigator Training – On-site regulatory start-up training for investigator-initiated studies.

Coordinator Mentoring - Counseling of new Department coordinators to identify and fill knowledge/experience gaps per CTSC SOP#3

Coordinator Recognition Event – once a year celebration of UC Davis clinical research professionals.

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.

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.

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
kmarusina@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 (Staff Only)
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.

SOPs (PDF)
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.