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Post-Approval Accounting

Billing for CSC Effort & Subsidy Accounting

NIH and federal accounting rules require that Investigators pay the full cost of CSC use, and then receive payment from the CTSI for the agreed-upon portion of these total costs that constitutes the CTSI subsidy for that protocol. In other words, funds must physically change hands between the research and CTSI accounts. The CTSI will provide a quarterly itemized bill to the investigator for the total cost of hourly protocol use on the CSC for each study, to be paid within 30 days to the CTSI account.

For simplicity, for each study visit this billed cost will be based on the time spent on the CSC unit as registered by WebCAMP and the integrated cost per hour calculated in the effort analysis. For example, a study with an integrated cost of $185/ hour in which the participant was present on the CSC for 150 minutes will be charged $463. Within 30 days, monies equal to the agreed upon subsidy will be electronically forwarded to the investigator’s account. For instance, if the above protocol had received a subsidy of 80%, $370 would be electronically forwarded to the investigator's study account for this visit.

Arrangements for billing and fund transfer should be made through consultation with Chris Chambreau (Chris.Chambreau@hsc.utah.edu).

Legacy Protocols

Protocols currently active on the CSC will retain their current subsidy level (usually 100%) as the PIP goes into effect. Principal investigators for each current protocol will receive a letter from the CTSI informing them of the value of subsidy provided to their protocol. Current levels of subsidy will continue for at least 36 months after the PIP inception date contingent on adequate protocol follow-up review as described below. Legacy protocols that continue beyond 36 months will be subject to re-evaluation by the IAC.

What Is a Protocol Manager? (PM)

The RN assigned to your protocol will be your PM. The PM will be your principal contact on the CSC and will work with your team to initiate and conduct the study as designed. Our RN protocol managers are expert research nurses—we hope you will rely on their expertise while conducting research with us.

Protocol Manager Role & Responsibilities

A protocol manager is assigned to each protocol by the nurse manager following IAC submission. There may also be a Co-PM assigned to assist. They will play a key role in the successful execution of your protocol, using strong management and organizational skills to insure that all participant visits are protocol driven. The protocol manager’s responsibilities will include:

  • Arrange initial Protocol Activation Meeting (PAM)
  • Coordinate with interdisciplinary teams as needed: dietary, research pharmacy, huntsman pharmacy, and the like
  • Monitor the protocol progress and addresses/manages obstacles
  • Serve as a primary contact for the protocol
  • Coordinate the development of nursing specific documents and plans
  • Provide mentoring role to study coordinator regarding necessary paperwork, billing, scheduling, and appropriate resources
  • Correspond with appropriate parties regarding billing prior to activation and throughout life of protocol
  • Ensure availability of appropriate equipment for specific protocol requirements