Clinical Research Education and Training
Clinical Research Coordination Course Description
UC Davis CTSC realigned the educational offerings to match Competency Domains adopted by the CTSA Consortium and outlined in the COAPCR publication "Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional," by S.A. Sonstein et al. Please note a competency domain attributed to each CRC 2.0 or 3.0 workshop.
LMS registration is required
Open only to UC Davis employees
CRC 1.0 - Introductory Course for Jr. Specialists and new CRCs.
This foundational course is specifically designed for new staff. It combines didactic training with hands-on training experiences to provide a solid foundation in research knowledge. Key areas include IRB, HIPAA Compliance, EMR Research Functionality, and Regulatory Documents. Learners will have an opportunity to participate in hands-on experiences with regulatory binders and EMR technology. The Course repeats several times per year to give an opportunity for new staff to attend. Eligible for CTSC CEUs.
CRC 2.0 - Basic Course.
Designed for investigators and staff who wish to improve their competency in the field of clinical research management. The modules provide advanced topics, such as IRB Reliance, Vulnerable Populations, Multicenter Studies and others. The course specifically addresses implications of regulations on performing clinical research activities at UC Davis. The CRC Basic 2.0 modules are offered throughout the year. Each module consists of a didactic material, and a hands-on training/exercise (e.g., mock clinical trial budget analysis and serious adverse event report). Eligible for CTSC CEUs.
CRC 3.0 - Annual Leadership and Professionalism Conference
Offered once a year this event features presentations from a variety of speakers on topics such as communication skills, professional growth, and team management. Crucial Conversations and Career Pathways in clinical research are examples of such topics. Presentations are followed by a dinner and awards ceremony, where outstanding clinical research staff is recognized for their achievements. Nominations are solicited from Departments. Eligible for CEUs.
Lab Safety Training Requirements
UCD Research & Education:
1. Laboratory Safety Fundamentals – on-line class required every three years as part of the UCLA Settlement Agreement.
- This on-line training class includes Fume Hood Training.
2. Laboratory Safety Training – ILT (Diane Hoffmann) required every three years (2016 schedule).
- This class fulfills IIPP, EAP, Laboratory Safety, Biosafety, Bloodborne Pathogens, Medical Waste.
- The in-between-two years the lab personnel are required to read/review, sign and date (as documented training) the annual laboratory training template.
3. Safe Use of Biological Safety Cabinets – this on-line class is required only once.
4. Hazardous Waste Management & Minimization – this class is recommended but not required. Information is included in Diane’s class.
5. Dangerous Good Shipping for Infectious Substances and Dry Ice, plus DOT Security Awareness – this is an on-line class (not through LMS). Training is required every two years if you are responsible for shipping this kind of material. Please contact Diane Hoffmann to access training information.
6. Radiation Safety – this class is required if you are working with Radioactive Material. Initial training is ILT through EH&S and on-line refresher training is required every three years.
7. Animal Use and Care – this on-line class (Animal Care 101) is required every three years if you are working with animals and on an animal protocol.
UCDHS – JACHO:
1. Mandatory Annual Training
2. Privacy & Security Training
3. Any additional training required for Health System employees.
Clinical Research Budgeting and Billing Course LMS#09155
The on-line course builds on the principles for clinical research billing provided by the ACRP eLearning Module "Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials." The regulatory environment related to clinical research billing is complex and compliance with relevant agency guidelines is a key part of every research study. This training program provides an orientation to the financial and administrative infrastructure that supports clinical research billing across UCDHS.
By the end of this course you will be able to:
- Identify steps of the research billing process;
- Determine what the study team must do to ensure compliance;
- Responsibilities others have taken on to support you and ensure research billing compliance.
Topics covered in the course:
- Correctly routing charges for hospital and clinic procedures and services
- Coverage Analysis in the Bridge
- EMR Research Study File (RSH) in Epic
- Association of the patient to the study
- Association of Orders and Encounters to the study
- Completion of Billing Review
- Verification of charges using Reports2Web billing statements
All study team members are encouraged to take this orientation program to prepare for this important process.
Questions? Contact Suzan Bruce, PRA IV, CTSC (firstname.lastname@example.org)
Clinical Trials Brown Bag Series
Monthly joint SoCRA/CTSC Brown Bags provide an opportunity to learn about new and exciting developments in clinical research around the world. Open to our clinical research colleagues from Sacramento Area and beyond. Eligible for CTSC CEUs, as well as SOCRA CEUs
For more information contact:
University of California, Davis
IRB Administration - Office of Research
Office - (916) 703-9162