22 - How a Small Oncology Research Office Improved Regulatory Management in the Absence of a Clinical Trials Management System: A Success Story

Background:  We implemented a Quality Improvement Project in our Oncology Research Office to strengthen Research Administration and Regulatory Compliance in the absence of a Clinical Trials Management System (CTMS). We are a multidisciplinary Cancer Institute, situated within a community-based healthcare system with multiple locations across the state.

Program

Description:  Without an effective CTMS, and because a majority (64%) of our Clinical Trials (n=125) rely on external IRBs, we lacked capability to know how many studies were open, when they would expire, whether personnel were up to date, and whether protocols had been updated (this is specific to protocols opened via the National Cancer Institute (NCI) Cancer Therapy Evaluation Program). We used a data visualization tool to create a directory of all Oncology studies, allowing us to access this information, thereby improving efficiency and regulatory compliance. Now we can identify studies for IRB closure, initiate proactive processes for completing continuing reviews, streamline personnel updates to the local IRB, and cross-reference protocol updates issued on the NCI Clinical Trials Support Unit portal against a comprehensive list of protocols open at our site, thereby ensuring that all essential documents are updated and that updates are processed and implemented.

Program

Assessment:  An initial review of the directory identified two major areas for improvement: we found (1) some studies that we did not realize were still open at our institution; and (2) some completed/closed studies for which we had been submitting unnecessary continuing reviews and personnel changes.
We conducted an audit of the identified open studies to determine whether: (1) any modifications had been issued; (2) actions were needed to address applicable changes; and (3) these studies could now be closed. We also closed the completed studies with the IRB, thereby reducing regulatory burden and freeing up resources for the remaining studies.
The inability to visualize our full portfolio was a barrier to ensuring robust regulatory management and compliance. Removing this barrier allowed us to identify areas of improvement and implement processes for standardizing workflows. We created trackers for subject accruals and protocol modifications which allow us to identify requirements for re-training/re-consent, ensure accurate reporting to the IRB at time of renewal, and assist with conducting internal quality audits as part of continuous quality improvement.

Limitations: The directory does not allow us to view or track version history of the protocol, consent form, or other key study documents. It does not allow users to access a list of enrolled subjects, or their current study status (e.g., active on study visits, long-term follow-up only, complete). We use spreadsheets to manually track accruals and ensure accurate reporting to the IRB. Additionally, the directory cannot extract data from external IRB portals.

Discussion:  This approach can be helpful for other research sites whose institutions do not have a CTMS in place and may not have the resources to implement one (e.g., sites which are part of a healthcare facility where research is not a primary focus of the institution). Data visualization tools are widely used across a variety of industries and organizations and can be a useful means of accessing data from multiple sources, which makes them useful for managing regulatory compliance of clinical trials if implementing a true CTMS is not an option.