Since October 2019, the West Virginia Clinical and Translational Science Institute’s Clinical Trials Center of Excellence 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.
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– 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 Jan. 1, but that are not registered will be suspended until such time that the trial is properly registered.
Nov. 1– OnCore implementation and use required for clinical trial management.
Jan. 1, 2021 – Implementation of COE registration fee for each clinical trial.