Department of Medicine OnCore Super Users Patrick Frazier and Leigh Powell discuss the positive aspects of the new clinical trial management software.OnCore is a comprehensive web-based Clinical Trial Management System (CTMS) that offers clinical trial lifecycle management, study participant and safety management and electronic data capture and reporting through its core module. OnCore also provides a platform for clinical billing review and study budget management as well as integration with other enterprise-wide systems such as IRAP or Greenphire.  

OnCore has been used by the Comprehensive Cancer Center and the Center for Clinical and Translational Science for several years and will be implemented enterprise-wide across the School of Medicine in three waves, beginning in December 2017 and January 2018 with the 11 division in the Department of Medicine. The remaining 26 departments will implement OnCore in April and September 2018. The additional Schools and Colleges with applicable clinical trials activities at UAB will be implemented after 2018. 

Here are some frequently asked questions about OnCore:

Why is UAB implementing OnCore? 

For the past 12 years, UAB has used SiteMinder to manage its studies with clinical billable services. While this system has served us well, it is no longer supported by its developer (Oracle). The implementation of OnCore across the institution will enable us not only manage our clinical billables within studies, but also to manage other important components of clinical trials including participant visits and study financials.  

Do we have experience with OnCore at UAB? 

Yes. OnCore was first introduced at UAB in 2010 when it was implemented at the Comprehensive Cancer Center (CCC). The system has been in use within the Center for Clinical & Translational Science (CCTS) in 2014 to help manage the clinical services they provide. 

What does Enterprise OnCore mean? 

Enterprise OnCore refers to the expanded installation of OnCore across all disease groupings. OnCore was originally developed for oncology clinical trials in 2000, and as study teams recognized the value in using the system for other kinds of trials, additional functions were added to better fit the needs of non-cancer trials. OnCore is now used in 31 academic medical centers and 13 health care systems in addition to 49 cancer centers across the US. 

Can data be extracted from OnCore?

Yes. Research administrative data needed for analysis can be exported in SAS or Excel formats. Researchers can use standard reports that exist within OnCore, and they can use its search tool for ad-hoc reporting. Searches can be saved and rerun quickly. Custom reports can be developed by the OnCore Report Writer, Nicky Welch (nwelch@uab.edu), and saved within the system for use. Data can be extracted directly from the back-end database by the OnCore Technical Administrator. 

What studies are required to go into OnCore? 

Currently, all studies that were previously managed in SiteMinder will be entered into OnCore. Unlike SiteMinder, however, activities in addition to the clinical billables, will also be built into the protocol calendar so that staff will be able to see all activities associated with participant visits and not simply billables related to CTBN creation. 

Can trials be entered that do not have billables? 

Trials without clinical billables may not be entered into OnCore at this time as that is outside the scope of the initial implementation. These trials will be addressed in the future.  

Will studies still be available in SiteMinder after implementation? 

Yes. Studies with an expected end date within 6 months of a Department’s go-live will not be migrated into OnCore and will continue to be managed in SiteMinder until the study’s completion. 

Can I access OnCore from clinic? 

Yes. OnCore is available from anywhere with an internet connection. An RSA token is required for off-campus access.

You can read more about OnCore on ONE or on the Clinical Trials Administrative Office website.