Agenda

Monday, March 9

  • 07:30 AM - 08:00 AM
    Registration and Continental Breakfast (provided)
  • 08:00 AM - 08:15 AM
    Welcome / Introduction
  • 08:15 AM - 10:00 AM
    Research Compliance 101 - high level overview of key research compliance issues -Human research protections, scientific misconduct, conflicts of interest, research billing, effort reporting, and more -Integration of research compliance into the corporate compliance program
  • 10:00 AM - 10:15 AM
    Break
  • 10:15 AM - 11:15 AM
    Health Care Compliance 101 -An overview of general compliance topics focusing on the elements of an effective compliance program -The infrastructure of a research compliance program - The Board’s role in compliance
  • 11:15 AM - 12:15 PM
    Lunch (provided)
  • 12:15 PM - 01:45 PM
    Human Research Protections -Overview of Federal Regulations governing investigators, institutions, IRBs - Discussion of frequent trouble spots identified in Determination Letters and Warnings, and how they can be managed - Interactive dissection of hypothetical scenarios and practical approaches managing thorny issues
  • 01:45 PM - 02:00 PM
    Break
  • 02:00 PM - 03:30 PM
    FDA-Regulated Research -Guidelines for determining whether research is regulated by FDA and, if so, by which component -Institutional and investigator responsibilities in FDA-regulated research: FDA and industry expectations for compliance -FDA inspections: What to expect and how to respond
  • 03:30 PM - 03:45 PM
    Break
  • 03:45 PM - 05:00 PM
    Conflicts of Interest - Identifying a potential conflict of interest that may introduce bias into the design, conduct, or reporting of research - Determining when action needs to be taken, and what actions are necessary and appropriate for reduction, management, or elimination of the potential or actual conflict -Action that can be taken to decrease the possibility of conflict of interest situations arising in the conduct of research

Tuesday, March 10

  • 08:00 AM - 08:30 AM
    Continental Breakfast (provided)
  • 08:30 AM - 09:45 AM
    Scientific Misconduct -Introduction to concepts of Research Misconduct: What it is and what it isn’t - Governing regulations -Remedies and consequences
  • 09:45 AM - 10:00 AM
    Break
  • 10:00 AM - 10:15 AM
    Certified in Healthcare Research Compliance (CHRC)® Exam Information
  • 10:15 AM - 12:00 PM
    Research Billing - In-depth review of rules for billing payors for clinical research services - Review a methodology for determining coverage of clinical research services - Overview of a clinical research Medicare coverage analysis
  • 12:00 PM - 01:00 PM
    Lunch (provided)
  • 01:00 PM - 02:00 PM
    Research Billing (Continued) -Review the impact of budgets and clinical trial agreements on billing compliance -Examine language in informed consent forms that impact billing -Discuss research billing coding
  • 02:00 PM - 02:15 PM
    Break
  • 02:15 PM - 03:30 PM
    Animal Research -Overview of the main regulators/regulations in the animal research arena -Working with institutional animal care and use committees, institutional officials, attending veterinarians, and other important players in animal research oversight -Case analysis: Issuing, spotting, and applying pertinent regulations in animal research settings
  • 03:30 PM - 03:45 PM
    Break
  • 03:45 PM - 05:00 PM
    Research Documentation and GCP -Understand what is the research record -Differentiate the research record from the medical record -Understand the basics of GCP and documentation standards/guidelines
  • 05:30 PM - 05:30 PM
    Networking Event (optional)

Wednesday, March 11

  • 08:00 AM - 08:30 AM
    Continental Breakfast (provided)
  • 08:30 AM - 10:00 AM
    Conducting a Research Risk Assessment -What is a risk and what does it mean to assess it? -Who needs to be involved in the process and why? -Identifying the risk and conducting the assessment -What do we do with the results?
  • 10:00 AM - 10:15 AM
    Break
  • 10:15 AM - 11:30 AM
    Auditing and Monitoring -Key elements of a successful health care research auditing and monitoring plan -How at least 2 key risk areas in health care research could be developed into auditing and monitoring tools -How to optimize health care research tools provided to apply to their individual organizations
  • 11:30 AM - 12:30 PM
    Lunch (provided)
  • 12:30 PM - 01:45 PM
    Grants Management -Discuss the basic requirements for grants management -Determine how to identify compliance risks related to grants management -Discuss the significant risk areas related to grants management -Understand effective management practices for managing externally funded research programs
  • 01:45 PM - 02:00 PM
    Break
  • 02:00 PM - 03:15 PM
    Data and Safety Monitoring Issues -Understand the criteria for establishment of a Data Monitoring Committee (aka DSMB) -Writing an operational charter for the Data Monitoring Committee -Key requirements for operating a functioning DMC
  • 03:15 PM - 03:30 PM
    Break
  • 03:30 PM - 05:00 PM
    Research Compliance Hot Topics & Watch List

Thursday, March 12

  • 08:00 AM - 08:30 AM
    Continental Breakfast (provided)
  • 08:30 AM - 10:00 AM
    Conducting an Internal Research Investigation -Being prepared is a key to conducting a good investigation -Where to look, what to look for, and how to find it -Interviews (and guidelines for conducting them)
  • 10:00 AM - 10:15 AM
    Break
  • 10:15 AM - 11:45 AM
    Privacy and Security Issues in Research -Overview of the basics of privacy and security in research -Discussion of HIPAA privacy and security in research -Discussion of FDA and other regulations that impact privacy and security in research
  • 11:45 AM - 11:50 AM
    Academy Ends
  • 01:00 PM - 01:15 PM
    CHRC Exam Check-In Time
  • 01:15 PM - 04:15 PM
    Exam Time — Certified in Healthcare Research Compliance (CHRC)® Exam (optional) The CHRC exam is optional. You must apply and pay for the exam separately from the Academy.

Agenda subject to change.

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