Introduction to Clinical Research for Junior Specialists/ new CRCs
December 3, 2015. Includes hands on training on EKG, Specimen Processing and Specimen Processing at the Clinical Research Center. Agenda is available and registration is coming soon.
Clinical Research Education and Training
Clinical Research Coordination Course Description
CRC 1.0 - Introductory Course. The course is specifically designed for department administrators, staff and physicians who may not be directly involved in clinical research or just beginning their clinical research career. The course highlights the main elements of the clinical trials process at UC Davis Health System. The course takes about 3 hrs and is designed to be interactive and hands-on. Participants will work in small groups of 3-4 people. With the support of the trainers, the teams will have a chance to develop a process map for clinical research and learn the roles/responsibilities of different individuals and entities contributing to the success of our clinical research enterprise. The course is offered on demand, with the flexible schedule based on the availability of the participants. For scheduling, please contact Kate Marusina, Manager, Clinical Trials, firstname.lastname@example.org.
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.
- Introduction to GCP
- Investigational Drug Management
- Study Management
- Clinical Trials Budgets
- AE, SAE, and Protocol Deviations
- IRB Submissions
- Medicare Coverage Analysis
- Study Documentation
- 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
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 2014-2015 series will focus on Advancing Regulatory Science for Public Health, based on the Framework for FDA’s Regulatory Science Initiative.
Recent breakthroughs in science and technology have a potential to transform our abilities to diagnose and treat diseases. For these advances to reach their full potential, the Food and Drug Administration (FDA) must use new scientific tools, technologies and approaches to bridge scientific advances and public health. This is Regulatory Science: the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. Without advances in regulatory science, promising new therapies may be discarded during the development process simply because we lack the tools to recognize their potential.
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 Certificate Course - Coming Soon!
The course is provided on demand. The course consists of three modules (Budgeting, Billing and Compliance). Each module includes two 120-min classes. Course materials include the UCD Clinical Research Guidebook, instructor presentation, department-specific protocol, budget, consent, contract, Coverage Analysis. Passing of an on-line quiz based on federal and state regulations, and UCD policy and procedures is required to receive the Certificate of Completion.
- 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 1: 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: Best Practices for Budget Development Process and Financial Impact
- Structure & organization of clinical trial agreements
- Guidance in completing an internal cost budget for clinical trials using the UBT
- Cost Query Tool and Cost-to-Charge Ratios
- Break-Even Database
- Invoice payment structure (SOP 7,9)
- Invoicing best practices
- Budget Negotiations
Module 3: An Overview: 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?
To request the course, contact Suzan Bruce, PRA IV, CTSC (email@example.com)