27 - Using a Cloud-based Electronic Management Tool to Track Progress of Reliance Agreement Completion and Improve the Reliance Process

Background: Tracking the status of pending site initiation can be intricate, complicated, and have the potential for disorganization. An electronic management tool that provides greater awareness, improves transparency for investigators and their study teams and sets clear expectations for the reliance process would be highly desirable.

Program

Description: Before this project, External Relations (ER) used Excel spreadsheets to track site initiation. We had separate trackers for Single and External IRB (IRB) studies. The trackers functioned relatively well while the number of studies were still small, but there were definite limitations as the portfolio of studies grew.

With a small team and a growing number of studies, we needed to improve efficiency by streamlining the process in a way that allowed all relevant parties/stakeholders access to the status of the site initiation. The ER evaluated different systems to determine what would meet our needs. ClickUp is a cloud-based project management platform that is supported by our MCIT department. We found that ClickUp allowed us to manage and track the progress of site initiation by creating a workspace for each participating site of a single IRB study in a way that the trackers could not.

Program

Assessment: ER can now track internal processes, receive action notifications via email, store documents, include links to the SMART portal or IREx to see the progress of each site’s reliance agreement, and communicate with the study team. By engaging the study teams, we have improved efficiency, gained support, and can share this information with them in real-time.

To test whether the study teams would be receptive to using ClickUp, guidance documents were created and shared with the teams. A separate link was sent from ClickUp so that they could view their study(ies).

Two weeks later, we sent the study teams a Qualtrics survey to assess if ClickUp was comprehensive, and easy to use. The results were overwhelmingly positive. 83% percent of our respondents felt that information regarding site initiation for their study was accessible and that using ClickUp made it easy to follow the process. When asked to rate their level of agreement to the statement – Having access to ClickUp allows me to provide real-time information to the sites’ study team – 33% Agreed and 50% Strongly Agreed.

Limitations: There are no best practices or guidance on all the necessary steps required to on board participating sites. Although this is a work in progress for us, and we will keep identifying ways to improve, the tool is fully functional, and results are measurable. We intend to re-visit our survey again at the end of 2023 to see if the investigators and their study teams still feel that ClickUp provides the intended transparency.

Discussion: With the increase of single IRB studies, there is a need for a management tool that will provide an efficient way to track the status of participating site initiation. ClickUp allows the creation of a workspace for each study, and the ability to manage the workflow needed for site initiation. The study teams can see a checklist itemizing next steps and who is responsible for those steps at each participating site. A notification will be sent to the team as each step is completed.