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Clinical Trials at UC Davis Health System

Clinical Trials at UC Davis Health System

  Happenings

CRC 2.0 Basic Course is now available for registration through UC Learning Center (LMS)

CRC Basic 2.0 is designed for investigators and staff who wish to improve their competency in the field of clinical research management. The course specifically addresses local implementation of GCP in performing day-to-day clinical research activities at UC Davis.

Topics Covered:

9/12- Introduction to GCP: Miles McFann, IRB Administration

10/10-Study Documentation: Elizabeth Mathis, CCRP, CTSC

11/14- AE, SAE, and Protocol Deviations: Elizabeth Mathis, CCRP, CTSC

1/8- Clinical Trials Budgets: Julie Calahan, Clinical Trial Budget Analyst

2/13- Medicare Coverage Analysis: Suzan Bruce, CPC, CTSC

3/13- IRB Submissions: Miles McFann,  IRB Administration

4/10- Investigational Drug Management: Joyce Lee, Pharm D., Investigational Drug Services

5/8- Study Management: Caren Galloway, CRC, Orthopedic Surgery, UCDMC

Questions? Contact Elizabeth Mathis

 

September 4, 2014
Clinical Trials Brown Bag

"Introduction to Regulatory Science."  Presented by: William Bentley, MD and James Polli, MD. Center of Excellence in Regulatory Science at University of Maryland

Webinar 12-1 PM at Ed Bld #2205. Remote attendance: www.readytalk.com;  Dial in: 866-740-1260, Access code (web and phone): 7039177 

 1.0 CTSC Continuing Ed Credit

 

Subscribe to free e-mail briefings from Huron. From the latest issue:

FDA Guidance Shelves Plan Intended to Help Accelerate Clinical Research on Medical Devices. A new final guidance document issued by the Food and Drug Administration is intended to "promote" clinical studies of new medical devices under the agency's Investigational Device Exemption (IDE) regulations. However, a program proposed by the FDA in 2013 for accelerating the clinical assessment process is no longer included. Regulatory Focus, August 19, 2014

 

  News

September 1, 2014

2014 UC Davis Clinical Research Guidebook  is now 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.

This resource is highly recommended for all members of the research team.

 

 May 5, 2014

Cadence Scheduling classes are now available at the UC Learning Center (lms.ucdavis.edu), multiple course #s

  • Intro to scheduling
  • Advanced scheduling
  • Check in/out and registration workflows

For more information see Cadence wesbite 

September 2014
Explore the new interactive UC Davis Clinical Research Process Maps. The maps designed to take you though the entire process in an easy-to-use intuitive way.

 

 

CT  Newsletter

Volume 20, May 2014

  • Important Update: The Bridge 2.0
  • Required: W-9 Forms for Human Subjects
  • What studies need to be in the EMR?
  • New! Technology Evaluation Process

 

  Need Help?

Where to start?  Many resources available for you from Clinical Trials Resource Group:

1. Clinical Trial Process Maps. Colorful maps helping you to navigate complex administrative process for clinical trials.

2. Clinical Research Guidebook. Puts words behind process maps, provides information about regulatory requirements.

3. Supplemental Checklist to the Guidebook. Don't have time to read the Guidebook? Use this condensed version to get you from the beginning to the end step-by-step.

4. Clinical Trials SOPs  - an invaluable resource for best practices of conducting clinical trials at UCDMC.

  Access Services

Spring 2014 Recharge Rates and discounts are now available.

Need help? Contact us