March 9 - 12, 2020
2020 March Research Compliance Academy
San Diego, CA, United StatesAgenda
Monday, March 9
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07:30 AM - 08:00 AMRegistration and Continental Breakfast (provided)
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08:00 AM - 08:15 AMWelcome / Introduction
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08:15 AM - 10:00 AMResearch 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
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10:00 AM - 10:15 AMBreak
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10:15 AM - 11:15 AMHealth 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
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11:15 AM - 12:15 PMLunch (provided)
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12:15 PM - 01:45 PMHuman 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
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01:45 PM - 02:00 PMBreak
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02:00 PM - 03:30 PMFDA-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
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03:30 PM - 03:45 PMBreak
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03:45 PM - 05:00 PMConflicts 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
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08:00 AM - 08:30 AMContinental Breakfast (provided)
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08:30 AM - 09:45 AMScientific Misconduct -Introduction to concepts of Research Misconduct: What it is and what it isn’t - Governing regulations -Remedies and consequences
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09:45 AM - 10:00 AMBreak
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10:00 AM - 10:15 AMCertified in Healthcare Research Compliance (CHRC)® Exam Information
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10:15 AM - 12:00 PMResearch 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
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12:00 PM - 01:00 PMLunch (provided)
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01:00 PM - 02:00 PMResearch 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
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02:00 PM - 02:15 PMBreak
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02:15 PM - 03:30 PMAnimal 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
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03:30 PM - 03:45 PMBreak
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03:45 PM - 05:00 PMResearch 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
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05:30 PM - 05:30 PMNetworking Event (optional)
Wednesday, March 11
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08:00 AM - 08:30 AMContinental Breakfast (provided)
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08:30 AM - 10:00 AMConducting 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?
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10:00 AM - 10:15 AMBreak
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10:15 AM - 11:30 AMAuditing 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
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11:30 AM - 12:30 PMLunch (provided)
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12:30 PM - 01:45 PMGrants 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
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01:45 PM - 02:00 PMBreak
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02:00 PM - 03:15 PMData 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
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03:15 PM - 03:30 PMBreak
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03:30 PM - 05:00 PMResearch Compliance Hot Topics & Watch List
Thursday, March 12
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08:00 AM - 08:30 AMContinental Breakfast (provided)
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08:30 AM - 10:00 AMConducting 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)
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10:00 AM - 10:15 AMBreak
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10:15 AM - 11:45 AMPrivacy 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
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11:45 AM - 11:50 AMAcademy Ends
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01:00 PM - 01:15 PMCHRC Exam Check-In Time
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01:15 PM - 04:15 PMExam 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.