View the details of an Ongoing Trial
You can view the details for any Ongoing Trial that you have access to.
- Open the list of trials you can access, and filter the list for Ongoing Trials, as described in View the list of trials you can access.
- In the Ongoing Trials list view, do one of the following:
- In the Study column, select the identifier of the trial you want to view the details for.
- Find the trial you want to view the details for, and select Go to study from the Actions drop-down menu on the right.
The [Trial Name] details page opens. A tab with the trial name appears at the bottom of the page. For example:![[Trial Name] details page [Trial Name] details page](img/studynamedetails_page_blur.png)
- At the top of the page below the page title, you can view the trial health key performance indicators (KPIs) that provide standardized metrics that measure trial performance consistency for the past 90 days to identify areas of operational risk.
The trial KPIs can include Enrollment Progress, Enrollment vs Plan, Site Activation, Data Entry, Deviation Rate, SAE Rate, Query Rate, Requery Rate, Dropout Rate, and Data Entry Timeliness. The trial KPIs 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.Ongoing Trials Portfolio - Key Performance Indicator (KPI) Description 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).
Dropout Rate Percentage of enrolled subjects that have dropped out or were terminated early. Appears only if you are not using a supported source application.
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. Appears only if you are not using a supported source application.
- Below the KPIs, you can view a summary health overview for the trial.
- In the Alerts section, you can:
Note:
The alerts are refreshed every 24 hours at 2 am UTC.- Sort the alerts by Severity or Alert Title.
- Select the following Actions for each alert:
- View Alert—Select to view the details for an alert. For more information, see View the details of an alert and provide feedback.
- Snooze—Use to pause the alert notifications to you. For more information, see Snooze an alert.
- Dismiss—Use to stop the alert notifications to you. For more information, see Dismiss an alert.
- Select View All—Use to open the Alerts list filtered for the study associated with the alert. For more information, see View the study details associated with an alert.
- In the Enrollment by Region section, use the View By drop-down menu to select a different view of the data graph. The options are: Enrollment by Region, Site initiated by Region, and Subjects Screened and Enrollment by Region.
- Select Close at the top left to return to the Trials list. The study name tab at the bottom of the page is removed.
Parent topic: Manage all trials