About The Guide

The Guide to Financial Compliance in Human Subjects Research has been compiled to assist the PI and the research team negotiate the increasingly complex world of research financial compliance. The Guide provides, in user-friendly format, a document that illustrates how to navigate the system at the UConn Health Center.

• It leads off with:
  • specific UConn Health Center policies on which all research financial compliance processes are built
• Then it moves on to a series of flow diagrams with accompanying narratives, and further sections that expand on:
  • developing a viable budget using the Budget Workbook, including a section showing the actual Workbook screens
  • distinguishing between “routine care” and costs directed to research (protocol induced costs)
  • how various types of research proposals flow through the institution, including specific routing instructions
  • requirements for clinical trial commencement, including how to register a study and obtain billing research accounts
  • how to register a patient in a research study and use of outpatient research labels
  • detailed in-patient procedures
  • patient vouchers and billing statement
  • specific General Clinical Research Center (GCRC), Computerized Physician Order Entry (CPOE), UConn Medical Group (UMG) and John Dempsey Hospital (JDH) procedures
  • review of research charges, closing out case numbers and study closure
• Additional sections include:
  • OCTR forms, including the Preliminary Budget Information Packet to be completed prior to the initial meeting between OCTR and the research team
  • description of research compliance monitoring, including audit information
• And finally, appendix material covers:
  • Connecticut law concerning health insurance for cancer clinical trails
  • acronyms and definitions used in The Guide
  • 2007 NIH research patient care rate agreement
  • identification of appropriate discount rates from standard fees, including rates for ancillary services
  • information on clinical trials billing under Medicare
  • frequently asked questions
  • OCTR contact information

A complete Table of Contents for The Guide is under Tab 1.