Set Up Sites on the Site Tab

The Site tab presents assumptions related to how sites in each location will be identified, qualified, and initiated.

• Global Versus By Location Specifications
  Because these assumptions can differ from location to location, you can specify values both globally and by location.
• Enter Site Management Assumptions for the Locations
  On the Site tab, you specify detailed site-related information for each location in the study or all studies at the same time.
• Assign Responsibilities
  You can assign tasks to specific service providers. In the Assignments/Responsibilities section of the Site tab you specify the outsourcing option for each location.
• Modify the Site Approval Schedule
  ClearTrial uses industry trends to calculate a default site approval schedule for each location. You can view or modify this schedule on the Site tab.

Global Versus By Location Specifications

Because these assumptions can differ from location to location, you can specify values both globally and by location.

1. First, specify the values common to all locations. From the Values apply to drop-down list in the Site Information section, select All Locations.
2. Then, specify values for the locations whose assumptions differ. From the Values apply to drop-down list, select a specific location.

   Note:

   It is not necessary to save specific values for each location in the study, only those that differ from those specified for All Locations. This is termed manage by exception.

Enter Site Management Assumptions for the Locations

On the Site tab, you specify detailed site-related information for each location in the study or all studies at the same time.

1. On the Site tab, in the Site Information section, from the Values apply to drop-down list, select All Locations or a specific location from the list.

   Note:

   All Locations means those locations for which the user has not provided specific values or overridden the values. ClearTrial uses these values when calculating effort and costs for any location currently defined or later added to the plan, unless you have defined separate values for that specific location.

   In this context, think of All Locations as all locations other than those that have been overridden.

2. For each field, enter the percentage of sites to which the information applies. For more information about any field, click the field name to display context-sensitive help.

   ClearTrial calculates and displays the number of sites represented by applying the specified percentage value. Note that sites and subjects are atomic; half sites and half subjects do not exist. For this reason, values are always rounded up to the next whole number.

   • The Percent of sites identified by sponsor may apply to sites that were used in previous studies or that the sponsor has a special relationship with. The cost of identifying these sites is assigned to the sponsor rather than to the vendor responsible for obtaining all of the regulatory documents and approving the sites.
   • Site visits add a significant cost to a trial. You can specify the percentage of the sites that require in-person visits versus remote visits.
     • Pre-study visits—If a site was used within the last year, by either the sponsor or the monitoring vendor, it usually does not need a pre-study site visit. Refer to your own SOPs regarding pre-study visits.
     • Site-initiation visits—This is normally equal to or less than the number of sites expected to participate in the study. On rare occasions, the study project manager might allow additional sites to be initiated (as back-ups) but, generally, will not approve the drug to be shipped unless the plan is to activate the sites later in the enrollment period.
     • Close-out visits—Normally, all sites participating in the study need a close-out visit when all subjects have completed the study. Therefore, the default for the field is 100%. However, there are some studies where this does not apply. For example, in Phase IV trials not done under an IND, it may not be necessary to close out the sites. In that case, the value for onsite close-out visits is 0%.
   • Clinical sites are paid based on certain milestones, subjects enrolled, data collected, and so on. In the Number of grant payments per site field, determine the number of payments to be made to investigators (average) over the course of the study. This value assumes quarterly payments (4), but you can override this value.
   • Percent of sites using local monitoring refers to sites assigned to monitors that work in the same city as the investigators. These sites do not require overnight travel or lengthy travel time to and from the site (generally less than 30 minutes each way).
   • Many sites require a percentage to cover overhead expenses beyond the standard investigator grant. Specify overhead in the Average percent overhead field. For example, university sites and other independent sites without university affiliations might require overhead. If you have not included this in the investigator grant amount on the Locations tab, specify the percentage of sites that require this additional overhead and the average percentage value.
3. Continue on the Site tab by entering personnel assignments and responsibilities. Click Next to enter treatment assumptions.

Assign Responsibilities

You can assign tasks to specific service providers. In the Assignments/Responsibilities section of the Site tab you specify the outsourcing option for each location.

Assign services providers and billing rates to tasks on the Assignment tab.

1. On the Site tab, in the Assignments/Responsibilities section, choose the outsourcing option for each group of assignable tasks. Setting an item to N/A excludes the associated tasks. Setting an item to Mixed implies you intend to assign each task uniquely on the Assignment tab or by using the Task Manager feature available to customers licensed for the Enterprise edition.
   • To assign a combination of responsibilities to sponsors and vendors, you must change the plan outsourcing selection on the Overview tab to Combination.
   • If you selected Conducted Internally on the Overview tab, you cannot assign any of the responsibilities to Vendor. If you have selected Outsourced, you cannot assign any of the responsibilities to Sponsor.
2. Click Next to specify treatment characteristics.