Dear DF/HCC Colleagues,
Most of you are familiar with the OnCore clinical trials management system currently used by DF/HCC to track the operational activities of our clinical trials. What you may not know is that the system is also utilized for critical clinical trials reporting required for the Cancer Center Support Grant (CCSG).
We successfully completed the CCSG renewal last June. A key discovery during the process was the challenge of obtaining accrual data for non-treatment trials. After careful internal evaluation, we realized the need to more systematically capture this data in our reporting efforts. Going forward for the next grant period, we would like to track all CCSG relevant accrual information in OnCore as our system of record.
Most study teams and CTOs already utilize OnCore for trial registrations. For those groups, there will be no change in process. However, for the subset of clinical trials that did not previously register subjects through the Office of Data Quality (formerly QACT), this change will necessitate that study teams of CCSG-relevant non-treatment trials record relevant study information in OnCore for each study subject.
The Clinical Trials Research Informatics Office (CTRIO) and the Office of Data Quality (ODQ) will work very closely with the affected study teams to get trials into OnCore going forward. ODQ will identify the trials based on CCSG criteria, and CTRIO will establish training plans to educate study teams on the process for registering subjects as well as the overall added benefits of using the OnCore system.
We realize that many study teams already manage registration and tracking of subjects utilizing various other methods and systems. However, registering subjects in OnCore will help to reduce the overall data burden and reduce transcription inaccuracies. OnCore is connected to the Epic electronic medical record and can easily pull patient demographic information. An additional benefit is the detailed reporting tools, that are available to study teams, within OnCore for ease of tracking accruals across trials and programs. For those that are interested, OnCore also provides study calendaring features that assist with planning and tracking subject-specific visit level activities in accordance with the overall protocol.
At this time our focus is on helping study teams new to the process get the appropriate training and assistance necessary to move forward. We are currently working on a detailed plan of how to approach already existing trials and assessing the type of support required to assist the teams to bring those trials into the system if possible. We will send additional information on existing trials once we have spoken with you and received your input.
Thank you in advance for your continued efforts and patience as we implement this new process. If you have any questions, please contact Nick Farley NicholasR_Farley@DFCI.HARVARD.EDU (Director of ODQ) or Erica Woulf Erica_Woulf@DFCI.HARVARD.EDU (Director of CTRIO) for further information.
Please forward this information to other members of your team who may have been inadvertently omitted from this message.