Specify Investigation Sites on the Locations Tab

On the Locations tab, specify the locations in which investigator sites will be established and subjects will be enrolled.

For each location, you are expected to specify the number of sites and subjects as well as the average investigator grant amount per subject. For more information about any field, click the column header to display online help.

1. On the Locations tab, click Add Location(s).
2. Select the location(s) to add. You can choose regions, specific countries within the regions, or a combination of regions and countries.

   Tip:

   Oracle recommends that you select either regions (if you are not sure of the exact countries) or specific countries (if you know which countries in which the study will be conducted).
3. (Optional) In the Filter section, choose a template or plan from which to import location-specific overrides.

   This feature allows you to use a template your organization created that already has user-defined defaults such as assumption field values, assignments and pinning, GL code and department mapping, and adjustments to indirect costs.

   A description of the selected template or plan appears in a table below the filter.

4. Click Ok.

   The tab refreshes displaying a table showing the added locations.

5. For each location row, in the Sites column, enter the number of sites expected to be approved and activated.
6. In the Submission Date column, select the date when you expect the location-specific regulatory submission package to be completed and submitted to the governing regulatory agency for review. The Submission Date defaults to the Project Activity Start Date. If you expect startup delays during outsourcing, you can override the Submission Date to the date the submission package is submitted. Milestones, such as First Site Approved (FSA) and First Subject First Treatment (FSFT) are extended accordingly.
7. In the MOH/FDA Delay column, estimate the number of days you expect the Ministry of Health (MOH) or Federal Drug Administration (FDA) approval time delay to last.
   • This value represents the number of elapsed days required in each location to obtain approval to proceed with the study. ClearTrial uses this number with other statistical factors to forecast the number of sites that should be approved by any particular date.
   • ClearTrial also uses this forecast to suggest and validate assumptions regarding the first subject enrolled date (FSFT/FPFT), the enrollment distribution type, and the first quartile enrollment objectives. You can override this value if necessary to reflect changes or other knowledge concerning the regulatory delay in any particular location.
   • You can override the suggested FSFT/FPFT date, enrollment distribution type, and first quartile objectives, which are based on the site approval forecast derived in part from this value.
   • If a large number of sites are in countries with very long MOH/FDA approval times, there may not be enough sites approved at the First Subject Enrolled (FSFT/FPFT) date to meet enrollment targets. This could require extending the enrollment period, reducing the expectation of enrollment by the first quartile, or moving the First Subject Enrolled (FSFT/FPFT) date to a later date. Alternatively, this could suggest that the study would benefit from the addition of sites in locations with shorter MOH/FDA delays.

   ClearTrial displays the First Site Approved date (FSA) per location based on the number of sites in that location and the expected regulatory delay.

8. Continue defining the plan locations by clicking Add Language(s).

• Support Languages and Translations
  ClearTrial suggests languages based on the locations specified. You can add or remove languages and dialects as needed.