Patient Enrollment
Overview
The patient enrollment report displays cumulative patient count over time for two events Screening and Randomization. The Select Network level dropdown is used to select which data to display. By default, this report displays study Screening data only, this can be changed using the Event filter.
This report also displays the buffer coverage curve. This line visually indicates how the buffer confidence dial relates to patient enrolment. In the example below, the buffer coverage is quite close to the maximum enrolment line indicating that a high buffer confidence setting has been selected and that only in the absolute maximum enrolment scenario would the buffer not cover the number of patients enrolling.
Example
Report Selectors
Study: Displays screening/randomization data for the entire study.
Depot: Displays screening/randomization data in relation to depots.
Region: Displays screening/randomization data in relation to regions.
Site Group: Displays screening/randomization data in relation to site groups.
Actual Site: Displays screening/randomization data from actual sites, up to the date of the RTSM extract.
Cohort: Displays screening/randomization data in relation to cohorts. Only applicable to studies that use cohorts.
Note: By default, data is reported in a combined view. Use the relevant filter to select the data required.
Patient Enrollment variability is reported for each Depot, Site Group, Region, and Cohort independently within our system. This allows for a detailed understanding of the potential range of Patient Enrollment figures at these organizational levels but also means that:
The combined total displayed when viewing Depot, Site Group, Region, or Cohort will not equal the Study level view.
The average value remains consistent across all reports.
Minimum and maximum values are only meaningful when a single entity (Depot, Site Group, Region, or Cohort) is selected.
Fields and Filters
The default fields for the Patient Enrollment report
Cohort
Determines which cohort(s) data is shown in the report.
Only shown when cohorts is selected as the network level.
Depot
Determines which depot(s) data is reported.
Only shown when ‘Depot’ is selected as the network level.
Data is combined by default. Use the filter to limit the report to the required data.
Event
Controls the event data displayed. Can be updated to display randomization, screening, or combined randomization and screening data; by default, only screening data is displayed.
Measure
Determines which data output (min/max/average) is reported. Min, max, and average results are included by default.
Only forecasted enrollment is represented with variability. Min, max, and average results display as three separate lines on the graph.
Actual enrolment data imported from an RTSM are shown without variability (displayed as a single line).
Patients Count
Reports the number of patients screened/randomized by period.
Region
Determines which region(s) data is reported.
Only shown when ‘Region’ is selected as the network level.
Data is combined by default. Use the filter to limit the report to the required data.
Site Group
Determines which site group(s) data is shown in the report.
Only shown when ‘Site Group' is selected as the network level.
Data is combined by default. Use the filter to limit the report to the required data.
Actual Site
Determines which actual site data is reported.
Only shown when ‘Actual Site' is selected as the network level.
Time
Reports the start date of the period for which screening/randomization data is shown. The size of periods is determined by the interval for enrollment and demand value selected in the forecast configuration.
Period start dates are displayed as rows by default.
RTSM Data Extracts
In forecast calculations with RTSM data extracts, the Patient Enrollment report shows actual data according to the RTSM extract data (without variability).
Note: 4C uses the date_registered field from the extract as the date of the Screen event, and date_enrolled field as the date of the Randomization event (if specified). The system does not use the visit table in the spec to determine these; it accepts the history as given in the extract.
