SRAS Clinical Trial Fiscal Management Project

Huron Consulting engaged to evaluate financial management of clinical trial research

Clinical trial research is an important component of the academic activities at the University of Kentucky.  The administrative issues related to the financial management of clinical trial research are challenging, but need to be addressed to facilitate efficiency and compliance.  We have engaged Huron Consulting to provide a nationwide perspective on best practices on fiscal management of clinical trial research.  Below is the provisional suggestion for the scope of the project:

Guidance on CTMS  (clinical trial management system)

  1. Provide guidance and supporting materials (e.g. baseline functional requirements, selection criteria, methodologies) in support of the selection of a CTMS
  2. Develop CTMS implementation plans, including high level scope, timeline, and overall implementation approach (e.g. phased rollout vs. “big bang”)
  3. Identify opportunities and requirements for legacy data migration and systems integration

Develop a staffing and organizational model to provide clinical trials administrative support services

  1. Clinical trial budgeting
  2. Contract negotiation, in coordination with Office of Sponsored Projects Administration (“OSPA”)
  3. Medicare Coverage Analysis (MCA) (coordination with UK Healthcare)
  4. Sponsor invoicing
  5. Ongoing study financial management
  6. Processing of subject payments
  7. Compliance and regulatory support in relation to fiscal management
  8. Study close out and reconciliation

The COM Research web site will be the reference source for information on the  progress of this evaluation.

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