Beginning on June 1, 2022, the WVCTSI Clinical Trials Center of Excellence (CT COE) will implement two required fees to ensure the compliant and efficient conduct of clinical trials at West Virginia University.
Over the past five years, the number of clinical trials at WVU has increased nearly 300 percent while the number of clinical trial participants has increased by 1000 percent. During this time period there has also been a large increase in regulatory requirements for clinical research.
“It is critically important that we implement systems that facilitate patient safety and enable busy investigators to efficiently conduct trials that are compliant with existing regulations,” said Dr. Sally Hodder, WVCTSI director and associate vice president for clinical and translational science at WVU.
A $975 one-time fee will be required for clinical trial registration with the CT COE. This fee applies only to new clinical trials. This fee does NOT apply to non-clinical trial human research (e.g., observational studies) and will NOT be collected on trials registered with the CT COE before June 1. This fee supports accurate accounting for ongoing trials and institutional risk assessment.
Support for OnCore, the Clinical Trial Management System, and eReg, an electronic regulatory system, will be borne by a one-time pass-through cost to industry, as well as by annual contributions from the WVCTSI and the six institute/departments that conduct the majority of the clinical trials
In addition to supporting the described electronic systems, these fees also support coordinator and investigator training, clinicaltrials.gov support, internal quality audits, and monitoring available without further charge to all investigators. Additionally, the OnCore system provides investigators with dashboards with which trial efficiency may be assessed and improved.
“WVU HSC investigators are bringing some of the most innovative clinical trials in America to West Virginians, and it is important that the systems and tools are available to our investigators to conduct those trials in an efficient, safe, and compliant manner,” said Dr. Clay Marsh, chancellor and executive dean for WVU Health Sciences.
Additional information on the CT COE and how to budget for these fees can be found on the center’s webpage. WVCTSI will host an information session on the CT COE and upcoming fees from 3 to 4 p.m. on Tuesday, June 21. Registration for this event can be found here. Any additional questions can be directed to Shelley Welch, director of the WVCTSI CT COE.
Please see directive on these fees from Dr. Clay Marsh and Dr. Fred King.