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Clinical Trials Resource Group

Clinical Trials Resource Group

The purpose of the UC Davis Clinical Research Guidebook is to provide a road map to navigate the processes and procedures for conducting clinical research at UC Davis. The Guidebook also serves as reference for investigators and site staff regarding the federal regulations governing clinical research in the United States.

The 2014 Edition of the Guidebook is a significant redesign of the 2013 Edition. It is divided into thirteen activities organized to help the investigators and their staff navigate through the various requirements of clinical research at UC Davis. The Guidebook is not meant to be all inclusive; more help is available from the UC Davis Clinical and Translational Science Center, the UC Davis IRB, Health System Compliance  and Health System Contracts – Clinical Trials Contracts

This Guidebook references materials from other sources with references cited whenever possible. Every effort was made to ensure the information is accurate as of the date of the publication.

The 2014 Edition closely follows the Therapeutic Interventional Process Map (download)


Download  FREE copy of 2014 Edition (registration required)

Order your own spiral-bound  paperback

Activity #1: Complete Necessary training 

Activity #5: Submit to IRB and Obtain IRB Approval Activity #9: Study Subject Scheduling and Regi-stration Activity #13: Study Closure
Activity #2: Study Develop- ment and Feasibility Activity #6: Approval by Health System Contracts (industry studies only) Activity #10: Investiga- tional Drug Pharmacy Appendix 1. Informed Consent
Activity #3: IND and IDE Submis-sions Activity #7: Study Activation Activity #11: Clinical Trial Mainte- nance Appendix 2. Comparison of Abbreviated and Full IDE Requirements
Activity #4: Prepare Regula-tory and Financial Documents Activity #8: Subject Recruit-ment Activity #12: Billing and Invoicing Supplemental Checklist for Investigators and Staff

This book was made possible by the efforts of:

Kate Marusina, Ph.D., Manager, Clinical Trials, CTSC
Kitty Lombardo, Administrative Director, CTSC
Tracy Hysong, Regulatory Analyst, CTSC
Miles McFann, IRB Analyst, Supervisor
Suzan Bruce, Research Coder, CTSC
Denise Owensby, CTSC, Clinical Research Supervisor
Virina De Jesus, Sr. CRC, CTSC
Elizabeth Mathis, CRC, CTSC
Gina Guillaume-Holleman, Research Compliance Analyst, Health System Compliance
Julie Calahan, Budget Analyst, Health Systems Contracts
Erick Jenkins, JD, Manager, Clinical Trials Contracts, Health System Contracts
Joyce Lee, Pharm.D., Clinical Pharmacist, Investigational Drug Service
Dan Redline, IRB Director
Steve Dana, Graphic Designer, ATS Mediaworks 

Download FREE copy of  the

2013 Edition