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Clinical Trials Resource Group

Clinical Trials Resource Group

  Happenings

Friday April 10, 2015, 2-5 pm
CRC 2.0

Investigational Drug Management
Registration required (lms.ucdavis.edu)
Presented by Joyce Lee, PharmD

Questions? Contact Lisa A Wilson

Thursday April 16, 2015
Clinical Trials Brown Bag

Topic: Building a Translational Safety Strategy: 
Safety biomarker qualification efforts in the Predictive Safety Testing Consortium

John-Michael Sauer, PhD, Executive Director, Predictive Safety Consortium, Critical Path Institute will provide an introduction to the Critical Path Institute (C-Path) and the institute's efforts around drug development tool (DDT) qualification with FDA, EMA and PMDA. The core of the presentation will discuss the safety biomarker qualification efforts of C-Path’s Predictive Safety Testing Consortium (PSTC) as they relate to the overall PSTC vision of creating an implementable translation safety strategy for drug development.

Attend webinar in person:@ Education Building, Room (#2205) Or dial in: 866-740-1260 AND log in into readytalk.com, Access code for both: 7039177

1.0 CTSC Continuing Ed Credit

 

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

It's Not Just You: FDA Regulatory Requirements Really Are Increasing

According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.
While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data. October 30, 2014

How To Build Real Patient-Centered Pharmaceutical Companies

With such a focus these days on buzzwords such as "patient-centric," "patient-centered," and "patient-centricity," some people are predicting “patient engagement” to be the next big movement in our industry, much as blockbuster drugs were a decade or more ago. But while improving patient engagement sounds fairly straightforward for those who directly interact with patients (e.g., doctors, nurses, nurse practitioners, and physicians assistants), for the biopharmaceutical industry, successfully executing this concept has been — and continues to be — much more challenging.

October 30, 2014

 

 

 

 

  News

April 9, 2015. 3rd Annual CRC Recognition Award Dinner and Education Event @ CHT Bld, rm 1331 

UC Davis CTSC will recognize Clinical Research Coordinators and others in CRC functional roles who demonstrated exceptional qualities to promote integrity and excellence for clinical research profession.

Three awardees will receive $75 gift cards and certificates of award.

Followed by the presentation by Beth Harper, BS, MBA President, Clinical Performance Partners, Inc.: Recruitment Recourse and Action Plans – Keys To Recruitment and Retention Success.

Dinner and Hosted Bar is included in the registration fee. Registration is now closed, but you can still attend and pay at the gate.

Save the date! June 5, 2015;  8am - 4pm @ CTSC

ACRP Certification Exam - Preparation Course Prepare for a CCRC® ACRP Certification exam! Familiarize yourself with the format of the exam, tackle example questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP Certification. No contact hours offered.

CTSC provides subsidies to UC Davis Employees for the Preparation Course and the Exam itself.

 More details to follow.  

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 22, March 2015

  • PFS requests review of research subjects missing from the Billing Report
  • Designate the Billing Reviewer for your Department/Division/ Center to run the Billing Report on the STUDY level
  • Expedite run time for Billing Reports by saving them
  • Obtaining Access to Protected Health Information (PHI)

  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