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Important Updates on COE Fees

WVCTSI has released updates regarding new upcoming fees related to infrastructure for clinical trial support at West Virginia University.

In recent years, institutional and regulatory requirements for clinical trials have increased. To meet those needs, the WVCTSI Clinical Trials Center of Excellence provides infrastructure that enhances participant safety, regulatory compliance and efficiency. To ensure continued support, these required fees are being implemented on June 1, 2022Trials registered before this date will not be subject to the fees.

  • COE Registration Fee: one-time $975 fee
  • Clinical Trial Management System (CTMS) Fee : one-time $2500 fee (Only applies to industry trials)

Anyone interested in learning more the Clinical Trials Center of Excellence or these fees should attend an information session being held from 3 to 4 p.m. on Tuesday, June 21. 

COE Fee Directive from Dr. Clay Marsh and Dr. Fred King

Clinical Research Infrastructure and Fees

How to budget for COE Registration fee

Clinical Trial Type: Industry Sponsored fees covered by pass-through cost to sponsors; federally-funded (non-industry) with indirects covered by indirects; WVCTSI funded pilots/scholars covered by WVCTSI; Cancer institute trials (cooperative group) indirects only with enrollment covered by indirects or cancer institute; unfunded investigator initiatied trials covered by departmental support

How to budget for CTMS fee

Industry Sponsored trials covered by pass through cost to sponsors

Frequently Asked Questions

  • When does the fee take effect?
    • June 1. Any trials registered before June 1 will not be subject to fees
  • What do these fees cover?
    • Training, internal quality audits and monitoring, OnCore clinical trial management, eReg system and system support, improved contract efficiency, as well as institutional risk assessments and feasibility assessments
  • How do I budget for my fees?
    • For Industry Trials both fees should be included as pass through fees to the sponsor. For Funded Trials with indirects, the COE fee will be covered by the indirects. For WVCTSI Pilots and Clinical Scholars, WVCTSI will provide the COE fee. For unfunded investigator-sponsored trials, the department will need to cover the COE fee. It’s important to note that the CTMS fee is only for Industry Trials and not Funded trials with indirect or unfunded investigator-initiated trials. 
  • How often do I need to pay these fees?
    • These one-time fees will be paid for any trial registered on or after June 1, 2022
  • Why are these fees being implemented now?
    • These fees have been implemented to meet the needs caused by the recently increased regulatory requirements for clinical research.