Reducing Overhead During Study Startup via System Integrations

Nicholas VanKuren, MS, Thomas Jefferson University Hospitals | Andres Garcia, MS, MBA Florence Healthcare | Ryan Jones, MBA, Florence Healthcare

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8.3x Reduction of Administrative Overhead During Binder Setup Phase of Study Startup


Research Sites Forced to Complete Redundant Tasks in Multiple Technology Platforms

NCI centers rely on a diversity of software systems to aid their clinical operations. Unfortunately, these systems create redundant tasks for research teams. For example, the process of adding a user in one system may have to be repeated in another.


Integrate CTMS & eReg Setup Tasks into a Single Administrative Process

In this research project, the Jefferson and Florence technical teams combined traditionally disparate CTMS and eReg administrative setup tasks into a single process.

Examples of administrative study setup tasks include creating a virtual trial binder workspace, inviting users to that workspace and configuring their permissions.


Reduce Administrative Workload to Eliminate Duplicate Efforts

The teams explored two questions:

1) Could the systems “talk” to one another, and could we automate study setup in the eBinders™ trial binder system by initiating the study in the CTMS?

  • Metric: Completion of workspace setup to spec.

2) Did this integration save the study or administration team time? Metric: Time spent on key configuration tasks

  • Metric: Time spent on key configuration tasks.


Integrate CTMS & eRegulatory Systems in order to Automate Six Setup Tasks

The result is that when a study is created or modified in the CTMS, the attributes of that study are sent to a middleware solution, configured programmatically, and are then established in the eRegulatory system. This results in a new set of binder structures, roles, and permissions that are immediately ready for use by the study team.

The Steps:

  • Create Binder Structure

  • Create Roles

  • Assign Permissions

  • Assign Users to Roles

  • Register and Activate Users

  • Validate Deployment


Permission and Role Setup Time Reduced from 27 Minutes to 3 Minutes Per Study

1) Basic functionality: The system ultimately satisfied the first functional goal. All six steps described above worked according to spec when launched from the CTMS.

2) Performance: Our temporal analysis showed a reduction in system setup effort when eRegulatory workflows are initiated from the CTMS.

Automating permissions assignment proved the single largest improvement. This change encompasses hundreds of configuration operations across dozens of users— the type of redundant task best done by software.


Continue to Drive Efficiencies Through Technical Integration

As the existing integrations free up resources from the most basic but critical activities, we are next exploring the possibilities of more complex workflows. These could include elaborate decision trees, as well as other systems such as IRB portals and electronic medical records. Ultimately, we seek to gain more efficiencies, reduce dependencies on scarce resources, and improve quality through tech integration.

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