Specialized Research Compliance Training

Client Situation

The Corporate Compliance Officer of a Children’s Hospital in the Midwest contacted us for help with conducting an operations review / risk assessment of its clinical research operations. Due to budgetary constraints however, the client wanted to conduct the majority of the review and assessment using internal audit staff and or methodologies. Specifically, we were asked to develop a comprehensive 5-day training program to: (1) enhance the internal auditors’ knowledge of overall risk areas; (2) discuss key risks / issues frequently encountered by us when performing reviews; and (3) train the auditors on our methodologies for identifying and assessing risk areas at Children’s Hospitals.

Core Competency: Teaching, Regulatory Expertise & Audit Strategy Development

Consulting Objectives:

• Develop a comprehensive training program and reference manual that would cover all applicable rules and regulations from the Office of Human Research Protections (OHRP), Food and Drug Administration (FDA), Medicare / Medicaid fraud and abuse (e.g., Stark), Medicaid billing, National Institutes of Health (NIH) and Internal Revenue Service (IRS).
• At the conclusion of the training, assist the client with developing a step-by-step work plan for the client’s use in conducting the review.

Approach:

• Using a business “life-cycle” approach, our training program addressed each point of the life-cycle from pre-award through post-award and account close-out
• Provide numerous “real-life” examples and solutions throughout the training program to ensure participant understanding of the subject matter.

Outcomes:

• The client was able to conduct the operations review / risk assessment with minimal follow-up questions for us.
• The training and reference manual provided is still referred to and used as the basis for training new employees, not only in internal audit, but the various operating areas as well.

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