8 Locations Tab

The Locations Tab is used to specify the locations in which investigator sites will be established and subjects will be enrolled.

For each location you need to specify the number of sites and subjects expected, as well as the average investigator grant amount per subject.

Adding Locations

On the Locations Tab, the Add Location(s) button is used to identify countries and regions in a study.

When adding locations in which you will conduct a study, it is recommend that you select regions if you are not sure of the exact countries. Or, you can select specific countries if you do know which countries the study will be conducted in.

For budgeting purposes, you can map reporting locations to regions with the Reporting Regions feature; for more information see Maintaining Reporting Regions.

To add locations to a study:

1. Navigate to the Locations Tab.

2. Click the Add Location(s) button to display the Choose Locations dialog screen. Select the regions and countries you want to include in the study. Click OK.

3. In the Number of Sites field, enter the number of sites expected at each location.

4. In the Subjects to Randomize field, enter the number the number of subjects to randomize for each location.

   Subjects to randomize is the number of subjects that will be given either the study drug/test article or an alternative treatment (e.g. placebo) in this Location. Drop rates and screen failure rates are accounted for on the Subject Tab.

   This field should contain only the number of subjects that will actually be enrolled in the trial. For instance, if the protocol calls for 1000 subjects to be randomized, enter 1000 here.

5. In the Avg Grant amount field, enter the average grant amount.

   The average grant amount is the amount of money that will be paid to each investigator in this location for each subject they enroll into the study. This should include only the amount paid to the investigator for each subject.

   Note:

   Do not include payments made for screen failures, university or other overhead associated with certain sites, or inflation. All of these items are accounted for separately on the Site Tab.

   The total for investigator grant payments will be included as a Pass-Through Cost in the budget. If you do not know the grant amount for a location, enter either your best estimate or zero. If needed, you may enter zero for the grant amount for all locations and the final budget will not include the grant.

   Furthermore, costs are estimated based on completed and partially completed subjects. A completed subject gets 100% of the investigator grant amount.

   A dropped subject is estimated to require payment to an investigator of 75% of the grant because ClearTrial expects the average to be closer to 75% of all visits completed since dropped subjects must return for the termination visits (generally a repeat of the last subject visit is regardless of where they terminate).

   These Pass-Through Costs can be adjusted if specific knowledge of the prorated grant budget is known.

   For endpoint studies, you should be sure to include the grant costs for both the standard treatment and full extended treatment schedules.

6. In the MOH/FDA Delay field, enter the expected Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time frame for each location.

   This value represents the number of elapsed days required in each location to obtain approval to proceed with the study and is used to help forecast the number of sites that should be approved by any particular date.

7. Enter information for each location and Click Save.

Removing Locations

On the Locations Tab, the Remove Location(s) button is used to remove a location from a study. Removing a location will delete all of the data associated with it.

To remove a location:

1. Navigate to the Locations Tab.

2. Select one or more locations.

3. Click the Remove Location(s) button.