How a Real-Time eTMF Dashboard Helps Keep a Trial on Track

Like its paper predecessors, an electronic Trial Master File (eTMF) houses thousands of documents. Each document relates to one of dozens or hundreds of processes that collectively comprise clinical trial work. The fact that this information is essential does not make it any less voluminous.

How can clinical trial and medical affairs team members sort through this avalanche of information to see what needs to be done, when, and by whom? Real-time dashboards provide these answers — making it one tool no eTMF can do without.

Why Dashboards?

A study management dashboard is a one-page overview of the status of a study, with key information for each stage. Dashboards use data visualization, charts and graphs, and other tools to communicate information quickly, allowing users to understand key metrics and make more informed decisions.

Study teams find dashboards useful for:

  • Receiving real-time updates. A dashboard can automatically communicate updates and changes in a study’s status.
  • Analyzing study data. Dashboard tools can collect data, including timelines for document creation or completion. This data may be analyzed to provide insights for this trial and future trials.
  • Seeing what’s next. As tasks are completed, each user can check the dashboard to see what information is available and what steps need to come next.

For a clinical trial team, a dashboard also helps ensure that key information is available on demand, whether the demand comes from other team members, study sponsors, clinical trial sites, partner organizations or regulatory bodies.

“Study managers increasingly rely on activity-based dashboards for reporting timely and user-friendly information to study stakeholders,” write Stephan Kudyba and Agnel D’Cruz in an article at Harvard Business Review. For clinical trial teams, dashboards organize essential information, making it readily available for audit and regulatory review.

Putting eTMF Dashboards to Use

Because every study has its own priorities and goals, there is no one-size-fits-all dashboard layout or solution. Yet effective dashboard tools do share three core similarities:

  • Intuitive. Users can easily find information on the dashboard.
  • Dynamic. Dashboards update as information is added to the eTMF. Users are not required to update the dashboard manually.
  • Customizable. Dashboards can be formatted to show essential information, display information in a particular layout, and adhere to role-based access controls (RBAC) so that users only see the information they are authorized to see.

With these three features as a foundation, a dashboard can be adapted to display essential information to each team member.

When implementing a study dashboard, prioritizing a few key elements can make the dashboard easier to use, writes RJ Messineo at ClearPoint Strategy:

  • Make it easy to scan and navigate.
  • Use visuals, like charts and graphs, to help users understand information at a glance.
  • Only include information that is essential at a glance — don’t clutter the dashboard with every study detail.
  • Encourage team members to consult the dashboard regularly.

Choosing the right dashboard elements is especially important for clinical trial and other healthcare teams. In a 2021 study published in Applied Clinical Informatics, Somayeh Fazaeli and fellow researchers sought feedback as they built and implemented a COVID-19 dashboard for use in an Iranian hospital. The researchers found user feedback helpful as they chose which information to include, how to display data, and how to arrange the dashboard’s elements.

The research team carried out their task in four phases, each of which is also applicable to the implementation of an eTMF dashboard:

  • Specify the context in which the dashboard will be used. While the eTMF provides a general context, dashboards may be adapted to serve a number of purposes within that context.
  • Clarify the requirements for the dashboard based on its context and purpose. Which key performance indicators must it track? What information do the dashboard’s users need and why?
  • Choose design solutions based on the dashboard’s context, purpose and goals.
  • Implement the decisions made and gather feedback on the efficacy of the resulting dashboard.

A robust eTMF, like Anju’s eTMF Master solution, has dashboard tools integrated automatically. Clinical trial teams won’t need to build their dashboards from scratch. Yet teams can still choose what data the dashboard should show and why, based on the team’s intended purpose for and use of the dashboard. Used effectively, real-time dashboards can help a clinical trial team stay on track.

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