April 14, 2016  Clinical Research Coordinator Leadership Conference, followed by 4th Annual CRC Awards Dinner and Reception. Last 3 days to register!

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 - Coming Soon!

The on-line course will combine theoretical knowledge provided by the ACRP elearning Module "Managing Billing Compliance Risk: Navigating Medicare in Clinical Trials" and the UC Davis-specific processes and procedures for ensuring compliant clinical research billing.

Learning Objectives:

  • Provide research staff with hands on knowledge of the Clinical Research Billing process
  • Explain the role and responsibility of various job functions (CAO, CRC, PI, Financial Analyst) in the Clinical Research Billing process
  • Describe and discuss clinical trial budget development process, including financial impact on the Department
  • Define Coverage Analysis and its role in Clinical Research Billing
  • Define the Clinical Research Billing integration into the informed consent process
  • Describe the Clinical Research Billing requirements for both drug and device claims
  • Discuss Compliance regulations related to Clinical Research Billing and audit preparedness
  • Utilizing UC Davis Clinical Research Guidebook, process maps, SOPs and P&Ps to achieve excellence in CRB Compliance 

Module description:

Module 1 (ACRP): Coverage Analysis, CMS rules, Qualifying Status

  • Describe the CMS Rules, Statutes, Regulations, Manuals, Transmittals and Guidelines
  • Apply the Essentials for Determining “Qualifying” Status of a Clinical Trial
  • Routine costs, medically necessary Medicare rules, billable services
  • Coverage Analysis concepts
  • Write Consent Language to Ensure Billing Compliance

Module 2:  UC Davis Compliance and Clinical Research Billing

  • Overview of Clinical Research Billing Compliance – implications to the research team, Department and the Health System
  • Implications of Erroneous billing (False Claims Act) and how it impacts our institution (provide examples of fines/penalties)
  • Bridge Overview
  • Billing System IT Components (i.e. associating your research subjects in EPIC) and understanding the EPIC Bill Hold and Charge Review Report
  •  Auditing and Monitoring Research Billing - What can you expect from a compliance billing review?

Questions? Contact Suzan Bruce, PRA IV, CTSC (skbruce@ucdavis.edu)