New! Orientation to Clinical Research Billing Course (#09155) is available through the LMS

  • Identify steps of the research billing process;
  • Determine what the study team must do to ensure compliance;
  • Your responsibilities for ensuring research billing compliance.

Clinical Research Coordination Course Description

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 Lisa Wilson, Sr. CRC, Clinical Trials,  lawilson@ucdavis.edu.

Topics Covered:

  • 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

 

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
  • eConsent
  • 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

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 (skbruce@ucdavis.edu)