Trial health key performance indicators (KPIs)

The trial health key performance indicators (KPIs) provide standardized metrics that measure trial performance consistency for the past 90 days to identify areas of operational risk.

The trial health KPIs provide standardized metrics and consistent measurements over time, which facilitates data-driven decision-making and supports the successful execution of clinical trials.

The trial health KPIs appear across the top of a trial details page below the page title. They are refreshed every 24 hours at 2 am UTC and are only calculated and shown if there is enough data for each.

Note:

You can hover over any KPI to see details about how its value was calculated, including the minimum and maximum values and the calculation date.

The KPIs can include:

• Enrollment Progress—Actual enrollment accrued in CTMS at the protocol level. This metric shows the total number of subjects enrolled for the trial at any time.
• Enrollment vs Plan—Actual enrollment divided by the planned enrollment (uses the enrollment forecast). This metric shows if the trial is meeting its recruitment goals.
• Site Activation—Percentage of activated sites that have met their activation target dates. This metric is a measure of start-up efficiency. A high variance signals bottlenecks.
• Data Entry—Percentage of expected CRFs completed (regardless of query status). This metric serves as an early warning of operational lag. Low data entry completeness correlates to monitoring backlog and slow data entry timeliness.
• Deviation Rate—Number of protocol deviations reported per 100 subjects across the trial. This metric represents a universal compliance indicator.
• SAE Rate—Serious adverse event rate per 100 subjects enrolled. This is a key portfolio safety metric that normalizes by exposure (compares safety risks across different studies).
• Query Rate—Number of queries raised at the site divided by the number of items on any started eCRF (for example, for data that has been collected so far).
• Requery Rate—Number of re-opened queries divided by the total number of queries. This metric shows when the site’s initial response was insufficient, incorrect, or generated a new query. This can occur if:
  • The initial site response did not close a query, resulting in a "re-query" to the site (the query state changed from Answered to Opened).
  • The initial site action (data change) did not close a query, resulting in a "re-query" to the site (the query state changed from Opened to Answered to Opened).

The following trial KPIs may appear on the page if you are not using a supported source application:

• Dropout Rate—Percentage of enrolled subjects that have dropped out or were terminated early.
• Data Entry Timeliness—Average number of days from the date of a subject visit to the date the data is entered into an eCRF in EDC. This metric provides an early warning signal for downstream delays in cleaning, reporting, and analysis.