Protocol Schema & Subject Calendar

Developing and managing protocol schemas showing schedules of treatments and tests that patients undergo in a study can be time-consuming and complex. This module addresses the inefficiencies of traditional schema building and management, and can save significant personnel hours across multiple departments.

The tool works in two ways. First, it allows researchers to develop a schema using common words and phrases found in clinical trials and a library of standard lab procedures. The result is a grid showing all the study events involving research subjects. The researcher can add rules to rows, columns or specific events on the grid to further specify conditions under which those events should occur, creating a totally customized schema. A test calendar is produced to verify schedule accuracy.

The module then generates calendars, scheduling visits based on schema-driven target dates. It enables staff to view calendars across multiple subjects and studies. Patient-version calendars are generated in a printable “refrigerator” format, and calendars for core labs involved in the study are also created.

The system provides one central location for nurses to enter test results and data. It ensures accurate information is available for budgeting, billing and scheduling personnel, who rely heavily on study schemas to coordinate their efforts.

Key Benefits:

  • Easily develop complex study schedules
  • Pull in official procedures and services
  • Apply rules (day 1, day 5, cycle 3) and exceptions (not on weekends)
  • Assign Procedures as Research or Standard of Care
  • Generate subject calendars
  • View events on multiple calendars
  • Mark events a scheduled, complete, or skipped
  • Protocol deviations (out of range) are automatically flagged