Site Home and Overview

The Site Home page provides access to the Site data and activities within a selected Site for the selected Project. This tab will be hidden if no current project exists in the user's session or if the user does not have permission for any features in the module. Users with permission will be presented with a list of sites that they have either read only or full access.

 

Site Overview Tab

The Site Overview tab displays key metrics that include summary statistics for subjects and enrollment rates for the current site. A list of Site Statistics variables will be displayed. The last date and time the Site Statistics were compiled will be displayed at the top of the Site Overview section.  If the Site Statistics have been queued for recompilation:

 

The System Variables that are displayed include the active System Variables from the System Variables system table that have a value of Yes for the Include on Site Overview field on the Usage tab. Data will be grouped by the Variable Group of each System Variable. The groups include:

 

A check in the TV column indicates that the Target was entered manually.

A check in the EV column indicates that the Value was entered manually. This column will be visible when the Enable Site Statistics Value Entry Configuration Variable under the Site configuration group is set to True.

 

When the Edit Targets button is clicked, the Site Target Set module will display the most current, active Site Target Set record (if one exists). Otherwise, the user will be able to add a new Site Target Set record. This button will be visible for users with Edit permission for the Site Management feature (see Roles).

 

When the Edit Values button is clicked, the Site Value Set module will display the most current, active Site Value Set record (if one exists). Otherwise, the user will be able to add a new Site Value Set record. This button will be visible for users with Edit permission for the Site Management feature (see Roles) and the Enable Site Statistics Value Entry Configuration Variable under the Site configuration group is set to True.

 

Each row of data will include the name of the System Variable, the Target and Value fields, and a Status Graphic Sprite control to display the percentage completed based on the Target and Value fields. The data will be retrieved from the most current Site Statistic Set.

 

will display if the Actual rate equals or exceeds the Target date and the Site will meet the projected completion date.

will display if the Actual date is less than the Target date and signals that the Site will not meet the projected completion date.

 

Additional information is available on the Documents tab and on the Side Panel (see table below).

 

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

 

 

Site Home Page Before Selecting a Site

 

 

 

Site Home Page After Selecting a Site

 

 

 

Side Panel displays general information on the selected Site. By clicking the Site Details link on the side panel of the Site Home Page, additional tabs open including Site, Memo, Finance, Custom Fields (if defined), Key Roles, Import, and Exclusions as long as the user has permission for the Site Management feature.

 

 

Site Details displays the Project Site page and allows you to view and edit  information.

 

 

      

 

 

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

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

 

 

 

 

Field

Description

SELECTION BAR

 

Project

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 as a Project team or Site Staff member.

Users can change the project by either:

  • Clicking the Project button to view a list of the user's current projects

  • Clicking the Left Arrow button to view the previous Project (in alphabetical order) of the user's current list of projects

  • Clicking the Right Arrow button to view the next Project (in alphabetical order) of the user's current list of Projects

An icon will display the status of the current project:

= Active

= Offline

= Read Only

= Test

Site Number/Name

The name is comprised of the Site number and the Site name. If a Site number has been assigned, it will be displayed; otherwise, it will be blank. The Site name is based on the Site Display Name Field Configuration variable under the Site configuration group. If the value is Institution Name and the institution has not been assigned to the site under the Site Staff module, then Unknown will be displayed. If the value is Investigator Name and the principal investigator has not been assigned to the site under the Site Staff module, then the name of the Principal Investigator will be displayed; otherwise, Unknown will appear.

= Startup

= Not Used

= Open

= Enrollment Hold

 = Closed

SITE DETAILS SIDE PANEL

 

Domain

The current domain is displayed. It is the Domain the project was added to within Domains.

Protocol

The protocol displays the Protocol Number field of the Protocol tab.

Country

The current country is displayed. It is the country assigned while setting up a site.

Site

The Site is the name of the site. It can display number and investigator name or number and site name based on the Project Configuration settings.

Status

The status of the site is displayed.

Institution

The displays the site's institution.

Site Key Roles

The key roles, such as PI, SC and Pharm, are assigned on the Site Staff page.

SMO

Site Management Organizations is displayed. If no SMO has been entered, then this field will be hidden.

IRB

Institutional Review Board (IRB) is displayed.

Site Group

Site Groups are displayed unless they have not been defined for the current project.

Custom Fields

This section displays one row for each Custom Field that meets these requirements:

  • the Base Table is Site

  • the Show on Overview checkbox on the Custom Field module is checked

  • the Custom Field is available in the current Project

The caption for each row will be set to the Overview Caption of the Custom Field if it has been defined; otherwise it will be the Custom Field Caption.

Site Key Events

This section will display one row for each Site Key Event Date. The values will be retrieved from the Site Events page. A row will be hidden if the Site Key Event Date has not been entered. The possible Site Key Events will include:

  • Initial Contact

  • Prestudy Visit

  • Regulatory Approval

  • Initiation Visit

  • Ready to Enroll

  • Enrollment Closed

  • Closeout Visit

Subjects Enrolled Per Month Chart

The X axis will be displayed as Months starting with the date that the first subject was enrolled up through the current date. The Y axis will be displayed as number of subjects enrolled. If no subjects have been enrolled in the current site, this chart will be replaced by a message indicating that no subjects have been enrolled. This Chart will be hidden if the Enable Subject Detail Configuration Variable under the Enrollment configuration group is set to False