By Mary O’Connell, CCRP, CTMS Analyst/Calendar Builder, Virginia Commonwealth University
OnCore® Enterprise Research has been the clinical research management system at Virginia Commonwealth University (VCU) Massey Cancer Center since 2006. In 2012, the decision was made at an institutional level to take OnCore enterprise-wide in order to develop a clinical trial database, support regulatory and financial compliance, and to improve overall clinical trial management. The implementation of the OnCore clinical research management module (which includes protocol and subject management) was initiated within the VCU School of Medicine (SOM) in July 2012, beginning with the department of pediatrics.
In order to educate the VCU SOM study teams in the use of OnCore, a set of work instructions was created which listed each field in OnCore, and the definition of the specific information to be entered. The instructions were used as a guide for the entry of clinical protocol information and for subject entry. It became apparent that the work instructions for the SOM differed from those used by VCU’s Massey Cancer Center.
Upon evaluation of the use of OnCore on an enterprise-wide basis, it was recognized that meaningful institutional reports of clinical trial data could only be accomplished with consistent definitions of OnCore fields across all organizational units. With the arrival of new leadership for the OnCore enterprise project in December 2013, the need to centralize clinical trial administration and standardize the procedures for the use of OnCore across the institution were seen as key issues to be addressed.
Forming the Policies and Procedures Working Group
The Policies and Procedures Working Group, also known as “P2,” was formed in January 2014 to facilitate the standardization of OnCore use across the enterprise. The group consists of representatives from Massey Cancer Center, SOM, and the Center for Clinical and Translational Research (CCTR). Members of the P2 Working Group have a wide variety of experience, including those with administrative, regulatory, and subject visit conduct expertise, as well as those with subject matter expertise in OnCore use.
The group initially focused on the PC Console and the fields in OnCore for new protocol entry. A spreadsheet was created that contained each field in OnCore, and the current definition from the previously established SOM work instructions. During each meeting, the data fields as shown in OnCore were projected onto a screen and a full discussion about the system functionality driven by the field followed. The current definition in the SOM work instructions and the current definition used by Massey Cancer Center were compared. Based on the system functionality driven by the field, and the utility of the current definition, field definitions and corresponding permissible values were amended or refined to meet the needs of an enterprise-wide use of OnCore. Special attention was paid to the fields within OnCore where data from one console is integrated into another console.
As each part of the console’s field definitions were refined and agreed upon by members of the P2 group, those definitions were added to the VCU Institutional OnCore Manual. The manual contains screenshots of the fields and the institutional definitions. This manual serves as the basis for training documents for OnCore use at VCU. Training videos and a Wiki page with a link in OnCore, that contains the P2 definitions and screen shots are being developed.
Based on the success of the P2 Working Group at VCU, creation of a similar OnCore standards team is recommended for any institution planning to implement OnCore on an enterprise-wide basis. If possible, establish your group prior to embarking on OnCore implementation and roll-out. Make sure that your group consists of representatives not only from administration and leadership positions, but also consists of individuals who are currently or will be using OnCore to manage subjects and enter data. It is critically important to engage the study coordinators and others who will be primarily responsible for subject registration and OnCore data entry. Once the definitions and permissible values for each data field are approved by the OnCore standards team (P2 Working Group at VCU), these semantic standards can be used to create your training materials for enterprise implementation of OnCore at your institution.