Since October 2019, the West Virginia Clinical and Translational Science Institute’s Clinical Trials Center of Excellence (COE) has supported clinical researchers by improving efficiency and efficacy of clinical trials at West Virginia University.
Through the COE, investigators are provided a variety of services geared towards improving the conduct of clinical trials. These services include FDA or sponsor audit readiness preparation and support, research personnel training, OnCore clinical trial management system training and support, internal regulatory monitoring and auditing. Additional services include IRB submissions, budget development and financial management, study coordination, and more.
In order to accomplish the Center’s mission of improved clinical trials participant safety and regulatory compliance, all clinical trials at WVU Morgantown’s Health Sciences Center and associated medical centers are required to be registered with the COE.
As clinical trial infrastructure continues to expand, there are some important upcoming dates and deadlines for principal investigators. Additional information will be released prior to each deadline.
- July 1, 2020 – Any WVU Health Sciences Center/Morgantown-based WVU Medicine clinical trial must be registered with the COE and obtain approval prior to starting enrollment. Those trials that were initiated after January 1,2020 but that are not registered will be suspended until such time that the trial is properly registered.
- November 1, 2020 – OnCore implementation and use required for clinical trial management.
- January 1, 2021 – Implementation of COE registration fee for each clinical trial.
“Establishing the Clinical Trials Center of Excellence is vital to our growing clinical research enterprise in West Virginia,” said Sally Hodder, MD, WVCTSI director and associate vice president for Clinical and Translational Science at WVU. “Not only does the COE facilitate principal investigator support through our Principal Investigators’ Academy, it also provides for more efficient contracting and enhanced regulatory compliance.”
WVCTSI is funded by an IDeA Clinical and Translational grant from the National Institute of General Medical Sciences (U54GM104942) to support the mission of building clinical and translational research infrastructure and capacity to impact health disparities in West Virginia.