Monday

Healthcare 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

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

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

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

Scientific Misconduct

• Introduction to concepts of Research Misconduct: What it is and what it isn’t
• Governing regulations
• Remedies and consequences

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

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

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

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

Wednesday

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?

Auditing and Monitoring

• Key elements of a successful healthcare research auditing and monitoring plan
• How at least 2 key risk areas in healthcare research could be developed into auditing and monitoring tools
• How to optimize healthcare research tools provided to apply to their individual organizations

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

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

Research Compliance Hot Topics & Watch List

• Important research compliance issues and trends not otherwise covered in the Academy
• Overview of the Foreign Corrupt Practices Act and UK Bribery Act as they impact international research and technology
• Detailed overview of Good Clinical Practice regulations and Good Manufacturing Practices as they relate to research • Applicable new laws, regulations, and enforcement trends related to the conduct of research

Thursday

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)

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

Exam Time — Certified in Healthcare Research Compliance (CHRC)® (optional)

The CHRC exam is optional. You must apply and pay for the exam separately from the Academy. To apply online, visit: hcca-info.org/Certification/ApplyforCCBCertification.aspx.

PLEASE NOTE: If you are not present at the specified "Exam Check-in Time" as listed above, and as determined by the exam proctor, you will not be allowed to sit for the exam. Actual exam duration is 120 minutes, per the Candidate Handbook. The time range, listed at left, includes mandatory exam procedures and proctor instructions.