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Clinical Research Education and Training
Clinical Research Coordination Course Description
CTSA Consortium is working towards achieving a standardized training platform in Good Clinical practices and the necessary means to disseminate it across all consortium sites.
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.
All CRC 2.0 training take place in Ed Bld, Room 2205
LMS registration is required
Open only to UC Davis employees
CRC 1.0 - Introductory Course for Jr. Specialists and new CRCs. The course is specifically designed for new staff. It combines the didactic training in key knowledge for clinical research, such as IRB, HIPAA Compliance, Lab Safety, EMR Research Functionality and Source Documents. it also offers hands-on opportunities to try EKG, blood pressure and specimen handling.
CRC 2.0 - Basic Course. Designed for investigators and staff who wish to improve their competency in the field of clinical research management. Upon completion of the Basic 2.0 program, participants will be prepared to coordinate clinical research projects from study initiation to close out in compliance with Good Clinical Practice (GCP) Guidelines. The course specifically addresses local implementation of GCP in performing day-to-day clinical research activities at UC Davis. The CRC Basic 2.0 training program is organized into 9 modules (listed below). Each module consists of a 60 minutes lecture, a 45 - 90 minute hands-on training/exercise (e.g., mock clinical trial budget analysis and serious adverse event report). Certificates of completion are issued after completion of the post-module quizzes and eligible for a 3.0-hour continuing education credit towards CNE, SoCRA, or ACRP. Participants can sign-up for individual modules or the entire course. Each module is limited to 20 participants.
REGISTER NOW through UC Learning Center (type lms.ucdavis.edu in your browser). Search for "CRC Basic" or use links below. Questions? Contact Rebecca Fein, Education Analyst, Clinical Trials, firstname.lastname@example.org .
- Introduction to GCP
- Study Feasibility and Start-up
- Clinical Trials Budgets
- AE, SAE, and Protocol Deviations
- IRB Submissions
- Data Management in Clinical Research
- Study Documentation and Quality
- Informed Consent Bootcamp
CRC 3.0 - Advanced Course. An advanced clinical trials training offered to both Investigators and Coordinators who manage multiple complex trials. Offered at least once a year, the focus is on in-depth topics in an all day, alternating lecture and breakout format. Topics may include but are not limited to:
- FDA readiness
- Tools to QC key audit areas
- Developing CAPA plans
- Study start-up
- Study feasibility-gaps assessment
- Protocol operationalization
- Process review to prevent deviations
- Patient recruitment and retention
- Issues faced by investigator-initiated multicenter trials
- Site engagement strategies
- Impact of remote monitoring
- Handling Monitor-CRC relationships
- Monitoring for investigator-initiated studies
- Time management for CRC- workload balance
See 2015-2016 Calendar for details
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 (email@example.com)
Clinical Trials Brown Bag Series
Monthly Brown Bags provide an overview of new and existing developments in clinical research around the world. Open to our clinical research colleagues from Sacramento Area and beyond.
The 2015-2016 series will focus on new and exciting developments in clinical research space, such as :
- Mobile Health
- Social influence of drug drug development and marketing
- Clinical Genomics program at the NIH
- Private Clinical Research Sites: Lessons learned
- Genomics in drug development
See 2015-2016 Calendar for details
All live webinars are from 12-1pm PST
To view slides: www.readytalk.com. Access code 7039177
Audio: 866-740-1260, Access code: 7039177