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Clinical Trials at UC Davis Health System

Clinical Trials at UC Davis Health System

Monitoring and Quality Assurance Program

Proactive regulatory assessment of trial activities for investigator-initiated studies

Clinical Research Budgeting & Billing

Medicare Coverage Analysis
Internal and External Budgets
Research subjects  in EMR/Invision

Clinical Trial Process Maps, SOPs and P&Ps

Navigate Clinical Trials Process
Clinical Trials SOPs
Health System P&Ps
IRB SOPs

Informed Consent BootCamp

Now in e-Learning format

Clnical Research Guidebook (2012)

Comprehensive compendium of clinical research processess and requirements at UC Davis

Clinical Trials Newsletters

Find the latest clinical research news, regulatory changes, FAQs, useful tips

Training and Education

2013 Calendar of Events 
2012 Calendar of Events
Training Archives

 

Investigational Drug and Device Applications

New Guidances for Exemption
Expanded Access/Emergency Use
Investigational devices
Step-by-Step IND/IDE

Investigational Drug Services

IDS Process map
Contact IDS
Important forms

Submit to Clinicaltrials.gov

Contact CTSC Administrator
Help with data upload

Clinical Research Staff Workgroups

CT Blog
Virtual Workgroups minutes
CRC Mentoring program

Submit to School of Medicine

What to submit  in the clinical trials packet?

Tools for Study Management

Helpful forms and links

Search Active Clinical Trials

Find active trials using keywords

Update Your Clinical Trials Listings

Add important information about your trial

 

July 2012

ANNOUNCEMENT:

You are cordially invited to join one of the three virtual workgroups:

• Education and Training Program
• CTSC-Based Mentorship Program
• Annual Recognition Event for Clinical Research Staff

Based on the results of the Clinical Research Staff Job Satisfaction Survey, these areas present the greatest opportunity for development. These virtual workgroups will advise CTSC on the scope, content and implementation of the programs. Your participation is critically important to address the needs of the clinical research staff.

ALL WORKGROUPS MEET BY PHONE OR WEB. NO TRAVEL REQUIRED.
Receive educational credit hours for your participation on workgroups.
Join at:  https://www.surveymonkey.com/s/Q93NG5C
 

1. Education and Training Program
Content of the SoCRA Brown Bags and Workshops
• UC Davis Clinical Research Guidebook, website and other materials
• CRC competency assessment
• Mandatory training program
• UC Davis staff proficiency certification

2. CTSC-Based Mentorship Program
• Scope and details
• Group or individualized
• General vs disease-specific
• Classroom or hands-on

3. Annual Recognition Event for Clinical Research Staff
• When and Where
• Format and Agenda
• Nominations and Awards
• Networking Events
• Clinical Research Staff Registry

Regular updates will be distributed in the Clinical Trials Newsletters.

 April 26,  2012.

Ice Cream Social and Discussion of the results fo the Clinical Research Staff Job Satisfaction Survey.

The overwhelming majority of the responders (97%) favored formation of a more formalized clinical research staff network, focusing on areas of: Education/Training; Career advancement; Networking; and Certification program. The survey highlighted the areas for further improvement, including Training and Education, access to mentoring resources, increasing PI involvement and improving job satisfaction. The next step will be the formation of the clinical research staff workgroups specifically addressing these areas.

Download the preliminary analysis

 If you have not taken the survey and would like to contribute, please enter here:

 

 

March 14, 2012

Agenda:

Discussion re: Implementation of the CRC Survey  at UCDHS

CRC Networking Society

 

 

Februrary 8, 2012

Agenda:

1) Live Webinar by Lisa Speicher, Director, Clinical Trials Office, Children's Hospital of Philadelphia

"Critical Need for Clinical Research Coordinator Training Support and Career Development: CRC Networking Society of CHOP"   

 Clinical Research Coordinators (CRCs) are an essential component of the clinical research enterprise, serving an essential role in human subject protection through the numerous activities and responsibilities assigned to them, and serving as the liaison between the investigators and the human research subjects, clinical care providers, regulatory bodies, sponsors and numerous others involved in the research process.  It is important for Academic Health Centers (AHC) to recognize that according to FDA regulations, the clinical investigator bears the ultimate responsibility for the conduct of the research study[i].  However, clinical research coordinators assume many responsibilities of the study which are delegated to them by the clinical investigators.  Given that the investigator is ultimately responsible for the conduct of the study, yet also must delegate many of the study related activities to the research coordinator,  it is imperative that the investigators together with the AHC ensure that the research coordinators receive adequate training and support to carry out each of the tasks assigned to them.  Provision of adequate training and support to the research coordinator is critical to the overall goal of human subject protection at a given institution.   This presentation will discuss an overview of the multifaceted, expanding role of the clinical research coordinators, highlight issues surrounding  inadequate support and training that AHCs should consider, present data on the current training and support and general job satisfaction of CRCs at Clinical and Translational Science Awards (CTSA) centers, and finally discuss approaches to support the retention of CRCs through certification programs,  promotion of career paths and networking opportunities for CRCs within an institution.

 

2) Special session for Coordinators involved in inpatient, short stay and emergency research: New SOP for patient scheduling and registration 

 

 

January 11, 2012

Agenda:

I. Industry Advisory Group (by phone):

Donna Spencer
SSF Deputy Operations Team Leader
US Affiliate, Oncology
Genentech, a Member of the Roche Group

 

Robin Douglas, MA, CCRC
Associate Director,
Integrated Site Services - Site Management
Quintiles

 

Heidi Hinrichs
Director of Clinical Studies Operations
St. Jude Medical (cardiovascular devices)

 

Agenda for the call:

II. How UC Davis can increase the sponsor outreach in our areas of expertise?

III. New SOPs approved
     PM (Patient Management) 311: Billing Corrections

IV. Open Forum

 

 

September 14, 2011

Agenda

1. Finalizing the training schedule and incorporation of webinars 2011-2012

2. Clinicaltrials.gov update
3. Introducing Process Maps for clinical studies

4. Response to question regarding V70.7
4. Discussion regarding blinded studies, Query Tool and Volunteer Services
5. Open Forum

( these topics can also be found in the CT Newsletter for September 2011)

 

August 10, 2011

Agenda

1. Collecting Coverage Analysis at SOM Sponsored Programs Office
2. Definition of fully-sponsored study and its relation to the consent form
3. Updated process for Radiology Research Orders
4. Updated process for Laboratory Research Orders
5. Process map study for consent forms - update from volunteers
6. How to define/collect the date when we began working on the protocol
7. Discuss Education/Training for 2011-2012

 

July 13, 2011

Agenda:

1. Q&A Session on Qualification of Clinical Trials for Medicare billing
2. Proposed plan for Coverage Analysis Training - for comments
3. Proposed process map study for consent forms - need volunteers
4. Speakers for SoCRA-certified Brown Bags and Workshops
5. The future direction of CRC workgroup


  (meetings are scheduled for the second Wednesday of each month)

 

Call or email if you have any questions. 

 Denise Owensby , Sr. CRC, CTSC, 916-703-9191 denise.owensby@ucdmc.ucdavis.edu