9 Site Tab

The Site Tab is used to enter site management information for each location in a study. This tab identifies details regarding how sites will be recognized, initiated, monitored, and closed out.

In addition, this tab allows you to specify the subject screen failure rate, drop rate, and other values that determine effort and costs related to investigator sites and monitoring. Because these values may differ from location to location, this screen allows you to specify values both globally and by location.

Editing Site Approval Schedule

The Site Tab allows you edit the Site Approval Schedule for each location in the study.

To edit the Site Approval Schedule:

1. Navigate to the Site Tab.

2. In the Site Approval section, choose a location from the list and click the Site Approval Schedule link.

   The Edit Site Approval Schedule dialog is displayed. This dialog is used to customize the site approval schedule for a particular location.

3. The Site Approval Schedule field displays the type of site approval schedule being used for this location.

   If the schedule has been modified, the Site Approval Schedule field will say “User-Defined.” If this location is using a ClearTrial calculated schedule “ClearTrial Default” is displayed.

4. The Default Site Approval Period field displays the default length of the site approval period. Additional weeks can be added to the schedule by entering a value in the Additional Site Approval Weeks field and clicking the Apply button.

5. In the Site Approval Table, adjust the number of site approvals for each week in the study.

6. Click Save.

Entering Site Information

The Site Tab allows you to enter information regarding subject and site information, and apply it to all locations or a specific location in the study.

To enter site information:

1. Navigate to the Site Tab.

2. In the Values apply to field, select either a location or All Locations from the Values apply to drop down. The site information entered will be applied to the location(s) selected in this field.

3. Enter site information for each location, or all locations, in the study and click Save.

4. Click Save to keep the values for the selected location, before selecting another location from this drop-down.

Responsibilities

The Responsibilities section includes radio buttons that allow you to indicate the outsourcing option for each group of assignable tasks. The outsourcing options include:

• Sponsor: Assigns all of the tasks in that group to the study sponsor.

• Vendor: Initially assigns all of the tasks in that group to the Primary Vendor specified on the Provider Tab.

• Mixed: Indicates that you would like to assign some of the tasks in that group to a vendor and other tasks in that group to the study sponsor; this can be done on the Assignment Tab.

• N/A: Indicates that none of the tasks in that group will be performed, if they are optional.

If you have selected “Conducted Internally” on the Overview Tab, you will not be able to assign any of the responsibilities to Vendor. Similarly, if you have selected “Outsourced” on the Overview Tab, you will not be able to assign any of the responsibilities to Sponsor.

If you determine that you want a combination of some responsibilities assigned to the Sponsor and some assigned to a Vendor, then change your selection on the Overview Tab to “Combination.”