Changes are coming for clinical researchers that we hope will both streamline your processes and give you more powerful tools to support your work. There are several major developments you need to be aware of:
First, IRB submissions are going completely electronic with the implementation of the Kuali Coeus Institutional Review Board online system. This is being phased in starting today (Aug. 19) when all new human subjects studies will be submitted through KC-IRB. (For details see this notice from the Office of Research Administration.)
Note that the KC-IRB system will also be used by IU Health-affiliated researchers around the state.
Second, the OnCore clinical trials management software system is being rolled out by the Clinical and Translational Sciences Institute (CTSI). This system, which has been in use at the IU Simon Cancer Center since 2005, provides a robust set of tools for managing trials: budgeting, scheduling, reporting and more.
The OnCore system, which is being implemented now in oncology (as a move from a departmental system to an enterprise system) gastroenterology, the Methodist Research Institute and soon in the Division of Cardiology, will provide the school with data we can use to support the clinical research enterprise. The plan is to have OnCore available system-wide in 2014. You can learn more about OnCore here.
Third, work is proceeding on the Power Trials software that will bring important tools to the Cerner electronic medical records system at IU Health. Notably, Power Trials will allow sophisticated and automatic screening for patients who are eligible for, or are already participating in clinical trials. It will also provide financial tools to facilitate billing for trials. You can contact Richard Kovacs for more information about Power Trials.
Finally, CTSI has acquired a software system called Virtify, which helps clinical researchers meet the requirements for posting trial information and results on ClinicalTrials.gov. More on that as information is available.
If you’re a clinical researcher it may seem like a lot’s coming at you at once, but the new systems are being phased in and over time we think you’ll like the new tools at your disposal.