30 - Reducing Manual Tasks to Improve Efficiency in a Growing Program

Background:  In response to a large and expanding research Portfolio, in January 2023, a Cancer Center initiated a third IRB/PB. The IRB office used this opportunity to optimize operational workflows and streamline administrative tasks.

Program

Description:  IRB submissions, reviews, review letters, and agendas are managed within the Center developed software system entitled Protocol Information Management System (PIMS.) Study teams submit new protocols, modifications to approved research, and continuing review reports (CRRs) to the IRB and our reviewers conduct all reviews within PIMS. An example of a time-consuming office activity included manual curation of the electronic agenda for either completion of reviews or pending completion for expedited reviews. With a third IRB, this process would be increasingly time consuming. In collaboration with the Clinical Research Informatics and Technology team, we created a Tableau dashboard and PIMS reports to extract data from different sections within the IRB agendas. Our goal was to increase efficiency and maintain the same quality of oversight with an expanded number of IRBs.

Program

Assessment:  The Tableau dashboard provides the IRB team with an overview of expedited submissions for all three IRB’s. The dashboard identifies submissions with a completed review, alerting the IRB team to finalize the review in the system and send the determination letter. The dashboard identifies expedited reviews pending for more than seven days, prompting the IRB office to contact reviewers for completion of outstanding reviews. Lastly, the dashboard highlights the expiration dates of pending CRRs so that reviewers may be notified of upcoming deadlines. The PIMS reports provide a summary overview of the reviews on a convened meeting agenda, identifying those that are pending or have comments to be highlighted at the convened IRB. These reports are shared with the IRB Chair(s) in advance of the meeting to highlight discussion items. The dashboard and reports have eliminated an estimated five-hour time block for this process which previously required manual abstraction. This new process has allowed our IRB team to improve operational efficiency and enhance workflows.

Limitations: The PIMS software is not programmed to calculate the amount of time an individual spends within the system. Therefore, our estimate of time saved is obtained from subjective feedback of various team members.

Discussion:  These innovations have permitted the IRB team to allocate more time to submission pre-review and identify problems prior to an IRB meeting. We have streamlined a process to enhance review timelines and improve satisfaction for the research community with the overarching theme of protecting human subjects participants.