Country Home Page and Overview Tab

The Country Home Page provides the ability to view and manage Project information for a single Country. This is useful in large multi-national Clinical Trials that have Country Managers in addition to a global Project Manager. Many of the features currently available on the Projects tab are also available on the Country tab.

The Country Overview tab displays summary statistics for sites, subjects, and enrollment rates for the current project and selected country. Additional tabs are available if the user has permission for the Country Management feature and the Configuration Variable, Enable Country Tab, under the Project Country configuration group is set to True. These include Projections, Top Enrollers, and Site Documents.

The administrator can determine the system variables, such as Initiated Sites, that display on this page by setting the value for the Include on Country Overview field on the Usage tab of the active System Variables System Tables to Yes.

Selecting a Country

To select a Country, you can either click the button, which will display the first record in the list or click the button to view the previous site in the list. Click to view a list of all Countries by Name within the project. Once a Country is selected, the Select button, i.e. , will change to that country, i.e. . To view the list of countries again, click the button again to toggle back.

Additional information can be found on the Side Panel (see table below).

Click Common Buttons for a description of the buttons found throughout the system and their uses.

Country Home Page Before Selecting a Country

Country Home Page After Selecting a Country

Side Panel displays general information on the selected Country. By clicking the Country Details link on the side panel of the Country Home Page, additional tabs open including Project Country and Key Roles as long as the user has permission for the Country Management feature. Custom Fields can be added by using the ProjectCountry base table.

Country Details displays the Project Country page and allows you to view and edit information. This chart will be visible if the Enable Subject Detail configuration variable of the Enrollment configuration group is set to True.

Screening* displays a chart of the number of Subjects screened per month for the selected Country.

Sites displays a chart of the number of Sites initiated per month for the selected Country.

Site Visits displays a chart of the number of Site Visits completed per month for the selected Country.

*The Screening Panel will be visible if the Enable Screening Configuration variable under the Enrollment configuration group is set to True.

Field	Description
Alerts:	Click the link for more information on the alerts.
	The user can view all messages. An alert indicates that there is an unread message.
	The user can view all tasks and mark them as either complete or incomplete.
	The name of the current project is displayed. Users can select projects to view or edit if they are in the System Administrator role or have an active role in the project in one of the following: Project team members Site Staff members When a user clicks the Prev button, the current Project will change to the previous Project (in alphabetical order) in the user's current list of Projects. When a user clicks on the Next button, the current Project will change to the next Project (in alphabetical order) in user's current list of Projects. An icon will display the status of the current project: = Active = Offline = Read Only = Test
Sites
Initiated Actual	This number is the count of Active Sites where the Site Status is either Open, Open to Enrollment, or Closed and the Initiation Date is not blank.
Initiated Target	This number is defined in Project Details, Targets tab, Sites field.
Closed Actual	This number is the count of Active Sites where the Site Status is Closed and the Closed Date is not blank.
Closed Target	This number is the Actual count of Initiated Sites.
%	This is the percentage of target reached.
Subjects
Screened Actual	This number is the count of Active Subjects enrolled at Active Sites and the Screening Date is not blank. This section will only be displayed if the Enable Screening Configuration variable is set to True.
Screened Target	This number is defined in Project Details, Targets tab, Screens field. This section will only be displayed if the Enable Screening Configuration variable is set to True.
Screen Failures Actual	This section will only be displayed if the Enable Screening Configuration variable is set to True. This number is the count of Active Subjects at Active Sites where the Screen Status is set to“Screen Failure.
Screen Failures Target	This section will only be displayed if the Enable Screening Configuration variable is set to True. This number is the Target Screen Subjects minus the Target Enrolled Subjects.
Enrolled Actual	This number is the count of Active Subjects enrolled at Active Sites and the Enrollment Status is either Enrolled, Completed, or Discontinued.
Enrolled Target	This number is defined in the in Project Details, Targets tab, Subjects field. The Project will have Completed Enrollment if the Actual Enrolled Subjects is greater than or equal to the Target.
Completed Actual	This number is the count of Active Subjects enrolled at Active Sites and the Enrollment Status is Completed.
Completed Target	This number is the Actual Enrolled Subjects.
Discontinued Actual	This number is the count of Active Subjects enrolled at Active Sites and the Enrollment Status is Discontinued.
Discontinued Target	This number is displayed as ‘ N/A’, but the Actual Enrolled Subjects count will be used for calculating the percentage.
Discontinued due to AE Actual	This number is the count of Active Subjects enrolled at Active Sites and the Enrollment Status is Discontinued and the Discontinuation Reason is defined as an Adverse Event in the Subject Discontinuation Reasons on the Project Tables.
Discontinued due to AE Target	This number is displayed as ‘ N/A’, but the Actual Enrolled Subjects count is used for calculating the percentage.
Discontinued due to Death Actual	This number is the count of Active Subjects enrolled at Active Sites and the Enrollment Status is Discontinued and the Discontinuation Reason is defined as a Death in the Subject Discontinuation Reasons on the Project Tables.
Discontinued due to Death Target	This number is displayed as N/A, but the Actual Enrolled Subjects count is used for calculating the percentage.
Visits Actual	This number is the count of active Subject Visits with a status of Completed.
Visits Target	This number is the sum of: Number of active Subject Visits with a status of either Potential or Completed Number of remaining Subjects (Target minus Actual) times the number of active Project Visits with one of the following visit types: Screening Visit (if the Enable Screening Configuration Variable is set to True) Enrollment Visit Onstudy Visit Completion Visit Cycle Visit (if the Enable Multiple Visit Cycles Configuration Variable is set to True) Number of remaining Screens (Target minus Actual) minus the number of remaining Subjects (from the previous step) times the number of active Project Visits with a visit type of Screening Visit If the number of remaining Subjects is zero, this value will set to zero If the number of remaining Screens is less than or equal to zero, this value will be set to zero If the Enable Screening Configuration Variable is set to False, this value will be set to zero Note: The visit types of Unscheduled and Additional Cycle Visit are not included in the calculation of Target Visits since by definition they are optional visits.
Cycles Actual	This line will only be displayed if the Project configuration variable Enable Multiple Visit Cycles is set to True. The Actual will be the count of the number of unique Cycle Numbers of active Subject Visits within each Subject where all visits within the Cycle have a status of Completed or Cancelled.
Cycles Target	This line will only be displayed if the Project configuration variable Enable Multiple Visit Cycles is set to True. The Target will be defined as the sum of: Number of unique Cycle Numbers of active Subject Visits within each Subject with a status of either Potential or Completed Number of remaining Subjects (Target minus Actual) times the number of unique Cycle Numbers for active Project Visits with a visit type of Cycle Visit
%	This is the percentage of target reached.
Enrollment by Subject Group
Actual	The total of the Actual and the Target columns in this section should equal the Actual and Target numbers of the Enrolled Subjects, respectively. This section will only be displayed if Subject Groups are defined for the current Project in the Project Tables page.
Target	This number is defined on the Project Tables page in the Subject Groups module.
%	This is the percentage of target reached.
Enrollment by Site Group
Actual	The total of the Actual and the Target columns in this section should equal the Actual and Target numbers of the Initiated Sites, respectively. This section will only be displayed if Site Groups are defined for the current Project in the Project Tables page.
Target	This number is defined on the Project Tables page in the Site Groups module.
%	This is the percentage of target reached.
Enrollment Rate	This section displays the target and actual enrollment rate and projected completion date for the project, as well as a flag icon to indicate the relationship between the actual and target columns.
Per Site/Month Actual	This number calculates as follows: The Average Number of Subjects per Day calculates as the total number of subjects enrolled divided by the total number of Open Enrollment Days for each site. The Open Enrollment Days are defined as the dates between the Initiation 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 excluded from the Open Enrollment Days calculation. The Average Number of Subjects per Day is multiplied by 30.475 to determine the Average Number of Subjects per Site per Month.
Per Site/Month Target	This number is defined in the Project Details, Targets tab, Enroll Rate/SM field.
Rate Flag
	The flag indicates that the Project has Completed Enrollment.
	The flag indicates that the Project has not Completed Enrollment.
Projected Completion Date Actual	The Actual Date calculates as follows: The Average Number of Subjects per Day is multiplied by the total number of Open Enrollment Days for each day in the future until the cumulative total of Subjects meets or exceeds the Target of Enrolled Subjects. A limit of days used in this calculation is defined in the Enrollment Rate Projection Maximum Days Configuration variable. This limit is required in the event that the rate is so small that the projection could exceed many years. If the calculation does not determine a Projected Date before reaching the maximum days, a value of Unknown will be displayed for the Actual Date. The calculation of the graphic percentage is calculated by: The total number of days from the Enrollment Start Date (found on the Project Projections Tab) to the Projected Completion Date divided by the total number of days from the Enrollment Start Date to the Target Date. The bar graph will be displayed in red if the Projected Completion Date is greater than the Target Date. If the project has Completed Enrollment (see calculation above in the Subjects section): The bar color will be displayed in dark blue (which will override the red color for a late Projected Completion Date). The percentage completed will continue to reflect the percentage of days below or above the projected date.
Projected Completion Date Target	This number is defined as the Scheduled Date for the Last Subject Enrolled Project Event.