15 Feb Study Team Training and Support for IRB Review Data Entry Processes
Since OnCore went live in 2018, the CTMS team has been reviewing system usage to identify opportunites to strengthen our key business functions and to maintain a high quality of data in our system.
One such opportunity where we can improve adoption and increase data quality is the timely and accurate entry of IRB review data into OnCore.
Entering IRB Review data into OnCore in a timely manner supports the following key functions:
- Opening trials to accrual in a timely manner
- Enabling teams to monitor outstanding IRB submissions
- Updating time-sensitive federally-mandated databases and websites to avoid financial and academic penalties (Clinicaltrials.gov, Clinical Trials Reporting Program, Cancer.gov)
- Reporting accurate information to the Data and Safety Monitoring Committee
- Attaching participants to the appropriate consent documents for monitoring
- Facilitating the CTMS Document Upload project that enables study documents to be transitioned to OnCore and away from services like Clinical FYI
Recognizing that this process can be time consuming and that the initial training for entering IRB review information could have been more robust, the CTMS team plans to offer additional training and support to study teams. The team is currently helping study teams in this process by scheduling one-hour personalized working sessions, where we can help regulatory coordinator staff practice data entry scenarios, address questions, and demonstrate helpful tips that will save time and improve accuracy.
These sessions started in mid-Febuary and will continue over the next few months. We want to thank study teams in advance for their support of this process. If there are any questions related to this topic, please email the CTMS team at ctmspm@uw.edu.