Subject & Enrollment Metrics (CTMS)

This page provides details on how Vault creates and updates the metrics related to subjects and subject enrollment. For general information about CTMS, see CTMS Overview.

Overview

Vault automatically tracks the following metrics for each Study, Study Country, and Site in your Vault.

• Total Consented
• Total In Screening
• Total Screened
• Total Screen Failed
• Total Enrolled
• Total Randomized
• Total Started Treatment
• Total In Active Enrollment
• Total In Treatment
• Total Withdrawn
• Total End of Treatment
• Total In Post-Treatment
• Total Started Follow Up
• Total In Follow Up
• Total Lost To Follow Up
• Total Lost To Follow Up Rate (%)
• Total Completed
• Enrollment Rate (subject per month)
• Screen Failure Rate (%)
• Drop Out Rate (%)

You can populate forecast and planned values for each metric. Vault updates the actual values for these metrics based on either a subject’s status or status dates, for example, Enrolled Date.

Creating Enrollment Metrics

Vault can automatically create Enrollment Metrics records before there are subjects in your system, allowing you to plan and prepare for future enrollment numbers.

Add the Seed Metrics Records entry action to the Study, Study Country, and Study Site lifecycle state where you want Vault to automatically create Metrics records. When the Study, Study Country, or Study Site enters the lifecycle state with the configured lifecycle action, Vault creates all necessary Metrics records, with Actual, Planned, and Forecast metric values set to zero (0).

If any Metrics records are already present at the time this action runs, Vault ignores these and creates records for the metrics that do not exist.

This action takes into consideration any metrics defined for omission by the Metrics Not in Use field.

Selecting Metrics to Ignore

You can select metrics that Vault will omit from various areas of the system by using the Metrics Not In Use picklist on a given study. For the metrics you select on this field, Vault:

• Removes any status lines for that metric from the Enrollment Graph on the CRA and Study Manager homepages.
• Removes the selected metric’s record from the Study, all Study Countries, and Sites under that study.
• Does not create new Monitored Metric records for any Monitoring Events related to Sites under the study.
• Does not create new metric records for the Study, all Study Countries, or Study Sites under the study.

You cannot select the metrics for Total Enrolled and Total Completed in the Metrics Not In Use field as these are used in completeness calculations for the study.

Metric Calculation

You can choose how Vault calculates metrics using the Metric Calculation field on each Study with the following options:

Status Snapshot

This option calculates metrics based on the value of the Subject Status field for each subject at the time Vault runs the calculation.

Date-Based

With this option, Vault will calculate metrics based on the date field that matches each metric. For example, Vault would calculate the Actual Enrolled metric based on the number of subjects with an Enrolled Date value.

You must set the Metric Calculation field to Date-Based in order to use the Subject Recruitment Planning feature.

Metrics Only

With this option, users enter Metrics Actual values manually at the selected ‘Subject Metrics Only Level’ (study, country, or site). Data cannot be entered at levels below the one selected. Vault rolls up Actual values to higher levels.

Transferred Metrics

With this option, an integration or Vault Loader transfers Metrics for all levels (study, country, and site) into Vault. Vault will not block or roll up any values.

Recalculate Enrollment Metrics

You can easily recalculate metrics, metrics over time, and enrollment status logs for a study using the Recalculate Enrollment Metrics user action. An Admin can add the action to a valid lifecycle state on a study. You can use this action to update metrics for a Study in advance of Vault’s scheduled updates. Execute it whenever you need to refresh metrics for your study.

For subject-based strudies, we recommend Admins configure this action for all Study lifecycle states when you are planning for or enrolling subjects. For studies where metrics are managed via the Metrics Only or Transferred Metrics settings, this action resets all existing metrics to zero. It also updates the Metrics Over Time records.

Enrollment Status Graph

Here is an example of the Enrollment Status Graph when not utilizing Subject Recruitment Planning:

Here is an example of the graph when you are utilizing Subject Recruitment Planning:

Enrollment Status Graph Elements

The Site Enrollment Status graph is made up of several different metrics.

These are the metrics displayed if your metric calculation is Status Snapshot and you are not planning for metrics over time:

Label	Appearance	Description
Planned Total Enrollment	Solid black line	Vault plots the first point of this line based on the Planned Finish Date on the First Subject In milestone. Vault draws from Planned Finish Date on the Last Subject In milestone to place the last point of this line. The number at the first point is always zero, while Vault pulls the number for the last point from Current Planned Total Enrolled metric.
Actual Screen Failed	Solid orange line.	Vault plots the points for the line each day based on the number of subjects counted in the Total Screen Failed metric when Vault runs the Enrollment Status job.
Actual Total Screened	Solid yellow line.	Vault plots the points for the line each day based on the number of subjects counted in the Total Screened metric when Vault runs the Enrollment Status job.
Actual Total Enrolled	Solid/dotted purple line.	Vault plots the points for the line each day based on the number of subjects counted in the Enrolled metric when Vault runs the Enrollment Status job. Vault begins the dotted portion of this line using today's date. Vault draws the enrollment number at this point from Current Actual Enrolled. Vault pulls data from Planned Finish Date on the Last Subject In milestone and uses the product of Actual Enrollment Rate and the number of months until the Planned Finish Date on the Last Subject In milestone.
Actual Total Randomized	Solid light green line.	Vault plots the points for the line each day based on the number of subjects counted in the Randomized metric when Vault runs the Enrollment Status job.
Actual Withdrawn	Solid red line.	Vault plots the points for the line each day based on the number of subjects counted in the Withdrawn metric when Vault runs the Enrollment Status job.
Actual Total End of Treatment	Solid blue line.	Vault plots the points for the line each day based on the number of subjects counted in the End of Treatment metric when Vault runs the Enrollment Status job.
Actual Completed	Solid dark green line.	Vault plots the points for the line each day based on the number of subjects counted in the Completed metric when Vault runs the Enrollment Status job.

These are the metrics displayed if your metric calculation is Date-Based:

Label	Appearance	Description
Planned Total Enrollment	Solid black line	Vault plots the first point of this line based on the Planned Finish Date on the First Subject In milestone. Vault draws from Planned Finish Date on the Last Subject In milestone to place the last point of this line. The number at the first point is always zero, while Vault pulls the number for the last point from Current Planned Total Enrolled.
Actual Screen Failed	Solid orange line	Vault plots the points for the line based on the number of subjects with a Screen Failed Date on or before that date.
Actual Enrolled	Solid purple line	Vault plots the points for the line based on the number of subjects with an Enrolled Date on or before that date.
Actual Randomized	Solid lime green line	Vault plots the points for the line based on the planned number of subjects with a Randomized Date on or before that date.
Actual Withdrawn	Solid red line	Vault plots the points for the line based on the number of subjects with a Withdrawn Date on or before that date.
Actual End of Treatment	Solid blue line	Vault plots the points for the line based on the number of subjects with an End of Treatment Date on or before that date.
Actual Completed	Solid green line	Vault plots the points for the line based on the number of subjects with a Completed Date on or before that date.
Actual Screened	Solid yellow line	Vault plots the points for the line based on the number of subjects with a Screened Date on or before that date.
Forecast Enrolled	Dotted purple line	Vault plots points for the line using today's date. Vault draws the enrollment number at this point from Current Actual Enrolled. Vault pulls data from Planned Finish Date on the Last Subject In milestone and uses the product of Actual Enrollment Rate and the number of months until the Planned Finish Date on the Last Subject In milestone.

Actual Lines

“Actual” lines show the actual numbers for a metric based on the Enrollment Status Log record’s date.

Hovering over an actual line shows the name of the metric, the associated Enrollment Status Log record’s date, the current Actual value for the metric in parentheses, and the Actual value for the metric on the date from the associated Enrollment Status Log record.

Summary Metrics

The Summary Metrics pane displays key enrollment metrics for your Site that are defined as follows:

Metric	Appearance	Description
Enrolled*	Orange percentage ring	Based on the number of subjects that have reached the Enrolled subject status.
End of Study*	Blue percentage ring	Based on the number of subjects that have reached the End of Study subject status.
Site Status (Study Manager Homepage)	Pie chart	Shows each site's status as a percentage of total sites.
Enrollment Rate (CRA Homepage)	Ratio	Shows subject enrollment as a ratio of subjects per month. Based on the Enrollment Rate Metric Actual field. Planned is based on the Enrollment Rate Metric Planned field.

* Your Vault may have a different label for these Subject Statuses.

As with the Site Enrollment Status graph, Vault updates these metrics with data pulled from subjects in your Vault, except for Enrollment Rate, which also pulls data from the First Subject In milestone.

Updating Metrics

Vault updates the metrics for the components on the study manager and CRA homepages with a few different jobs. For further information about the jobs, see Managing Subject & Enrollment Metrics.