Projections (Project and Country Home Page)

The Projections tab of the Project Home Page displays more detailed information on enrollment projection data for the current project that is viewed on the Project Overview tab. This tab will be hidden unless the user has permission for the Project Management feature.  Additional tabs are available if the user has permission for the features. These include Overview, Top Enrollers, and Site Documents.

 

The Projections tab of the County Home Page displays more detailed information on enrollment projection data for the current project in the selected country that is viewed on the Country Overview tab. This tab will be hidden unless the user has permission for the Country Management feature.  Additional tabs are available if the user has permission for the features. These include Overview, Top Enrollers, and Site Documents.

 

Click here for a description of the Common Buttons found throughout the system.

 

 

Project Projections Tab

 

 

 

 

Country Projections Tab

 

 

Field

Description

Projection Results

This section displays the Subjects per Site/Month, the Projected Completion Date, and a Status Graphic Sprite to indicate the relationship between the Projected Completion Date and the Target Completion Date for each of three different rates.

Required Rate

This is the rate that is necessary to complete enrollment by the target date. The Target Completion Date which is defined as the Target Date for the Last Subject Enrolled Project Event. This line displays the rate of subject enrollment per site per month that is needed to meet the Target Completion Date. The Target Completion Date will display in the Projected Completion Date column.

Overall Rate

This line uses the values from the current Project Statistics. The Subjects per Site/Month column uses the value of the Enrollment Rate per Month System Variable. The Projected Completion Date column uses the value of the Enrollment Completion Date field. 

 Recent Rate

This line displays the rate of Subject Enrollment per Site per Month for a number of Recent Days.

  • The number of Recent Days is defined as the Enrollment Rate Recent Days Configuration variable under Enrollment configuration group (default is 90 days).

  • The Recent Start Date is calculated by subtracting the number of Recent Days from the current date.

 

The rate is calculated as follows:

    • The Average Number of Subjects per Day is calculated as the total number of subjects enrolled divided by the total number of Open Enrollment Days for each site during the time period between the Recent Start Date and the current date.

    • The Open Enrollment Days are defined as the dates between the latest of the Initiation Date and the Recent Start Date and ending on either the Closed to Enrollment Date, the Closed Date, or the current date, whichever comes first.

    • Dates within the Open Enrollment Days that overlap with the Site Date. Exclusion Dates are not excluded from the Open Enrollment Days calculation.

    • The Average Number of Subjects per Day will then be multiplied by 30.4375 to determine the Average Number of Subjects per Site per Month.

Status

The Status displays the number of days until the Target Date or the Number of Days Early or Late.

Flag

 

A Critical icon appears if the Projected Completion Date is prior to the current date, if the Target Completion Date is prior to the current date or if the Projected Completion Date is unknown.

A Warning icon appears if the Projected Completion Date is after the Target Completion Date.

 An OK icon appears if the Projected Completion Date is on or before the Target Completion Date.

Enrollment Projection Chart

The time points on the X axis are:

  • The Start Date of the chart are the Enrollment Start Date field in the Projection Parameters section

  • The End Date of the chart are the maximum Projected Completion Date from the Projection Results section. If any of the Projected Completion Dates are Unknown, the End Date of the chart will be calculated by adding the number of days defined in the Enrollment Rate Projection Maximum Days Configuration variable under the Enrollment configuration group to the current date.

 

The chart has four series of data points, using a cumulative number of Subjects on the Y axis. The four series are:

  Enrollment Plan

  • This series is based on the Target Enrollment Rate as defined on the Project Dialog. This rate is multiplied by the cumulative number of Open Enrollment Days for each date on the chart.

  • This series begins on the Start Date of the chart and ends on the current date on the chart.

  Overall Rate

  • The first part of this series is based on the actual cumulative Enrollment for each date on the chart up to the current date.

  • This second part of this series is based on the Average Overall Rate from the Projection Results Section multiplied by the cumulative number of Open Enrollment Days for each date on the chart from the current date until the End Date of the chart.

  Recent Rate

  • This series begins on the current date on the chart and end on the Projected Completion Date for the Recent Rate line in the Projection Results or the End Date of the chart, whichever is earliest.

  Required Rate

  • This series begins on the current date on the chart and ends on the Target Completion Date.

  • If the Target Completion Date is prior to the current date (or has not been defined), this series will not be displayed.

Projection Parameters

 

Target Subjects

This number is defined under the menu option Project Targets. The Target Subjects should match the Target column of the Enrolled Subjects line on the Project/Country Overview Section.

Enrolled Subjects

This number should match the Actual column of the Enrolled Subjects line on the Project/Country Overview Section.

Remaining Subjects

This number calculates the difference between the Target Subjects and the Enrolled Subjects.

Enrollment Start Date

Enrollment Start Date will ignore all Unknown Date values for the following steps:

  • The Completed Date of the First Site Ready to Enroll Date Project Event will be used.

  • If no value is found, then the Completed Date of the First Site Initiation Visit Project Event will be used.

  • The Completed Date of the First Subject Enrolled Project Event will be used if it is prior to the Completed Date from the previous steps.

  • If no value has been found for the previous steps, the Completed Date of the Project Start Date Project Event will be used.

Target Completion Date

This number is the Target Date for the Last Subject Enrolled Project/Country Event. If no value has been entered for the Target Date, the Project Thru Date on the Project Dialog will be used.

Site Days Used

Site Days Used is calculated as the sum of the Site Days for all sites used in the Enrollment Rate calculations.

 Site Days Remaining

This number will be calculated as the sum of the Site Days left between the current date and the Target Completion Date. If the Target Completion Date is prior to the current date, this field will be set to zero.