Protocol Insights
Protocol Insights delivers a predictive risk assessment based on historical data.
Predictive Scores
The dashboard provides a Protocol Complexity Index, Inclusion/Exclusion Criteria Risk, and Amendment Risk Factors. The bottom of the insights page shows details about these scores.
Overview tab
Actionable Insights
The Actionable Insights section of the Overview tab contains insights on Site Feasibility, Language and Syntax, Patient Recruitment Risks and Regulatory Risks, as well as Other Insights.
Each insight dropdown will have a number that reflects the number of insights available in that section. Click on the drop-down to read more.
Protocol Benchmarks
The protocol benchmarks compare the protocol's metrics against industry percentiles.
Patient Burden tab
The Patient Burden tab helps you to quickly identify the most invasive or burdensome procedures and activities in the protocol.
Click on a topic below to learn more.
Patient burden analysis
The Patient Burden Analysis gives the total estimated time commitment for patients in the first year. The time commitment is broken down further by Lab/Blood Work, Imaging, Assessment/Questionnaires, and Other Activities. You can view the time commitment for the other arm(s) by using the dropdown button at the top right.
Patient burden heatmap
The patient burden heat map shows how much time patients spend per week. Each cell represents one week. Colors show how much time each week requires.
Hover over a cell to see the week's overview:
Click on a cell to see a detailed list of the visit(s) and activities:
High burden and invasiveness profile
The High burden and invasiveness profile section highlights the visits that are invasive or a high burden for patients.
Timeline tab
The Timeline tab contains the Schedule of Events (SOE) and the Protocol Graph. In this section, you can: select an arm from the dropdown, search for activities, and apply an Invasive only filter.
Click on a topic below to learn more.
Schedule of Events (SOE)
The SOE shows the types of activities at each visit. At the top of the table, a key shows the meaning of each activity type.
View visit cycles
Visits that are associated with visit cycles have a cycle icon in the column header.
Footnotes
To view all footnotes, click the notes icon next to the Activity cell in the SOE table header.
A side panel will open to show All Footnotes, organized by activity. Each footnote includes its name and contents. Scroll to view all footnotes. Click X or press Escape to close the panel.
Visit-specific activities
If an activity has a note icon, it has visit-specific instructions. Click on the note icon.
A side panel will open with visit details. Click X or press Escape to close the panel.
Protocol Graph
The protocol graph shows the path a patient takes through the study. The color of each visit shows which phase it belongs to: purple for screening, blue for treatment, and green for follow-up. The numbers next to each visit show the window of days when that visit can take place.
Use the buttons to zoom in, zoom out, and center the graph. You can also scroll to zoom and drag to move the graph.
Cycles
Cycles will be shown with brackets over the visit(s) and show repetition count or an infinity symbol, if there are infinite cycles.
