View Expected Study Costs on the Summary Tab

The Summary tab provides a quick view of the plan's calculated budget forecast. While the Reports tab offer detailed reports, the summary is useful for “what-if” scenarios benchmarking against a vendor bid.

ClearTrial computes monetary values by converting each service provider's billing rate currency to the modeling currency, using the exchange rates specified on the Overview tab (or any overrides specified by provider).

• Filter the Summary by Providers
  Begin your summary by selecting the providers to include.
• View the Fees and Indirect Costs
  The Totals section provides a quick way to view the total study costs broken out by direct and indirect labor fees (pass-through or miscellaneous) and with and without inflation applied.
• Group the Fees and Costs
  Select a grouping by which to summarize fees and costs.
• Review Fees, Hours, and FTEs
  The values in the Fees, Hours, and FTEs section are displayed according to the grouping you selected.
• Review Costs by Grouping
  The total indirect costs are displayed broken out by cost category type, and with or without inflation applied.
• Review Dates and Duration
  This section summarizes study-related dates and durations.
• Review Metrics
  This section includes the cost per completed subject and the average number of subjects per site per month.

Filter the Summary by Providers

Begin your summary by selecting the providers to include.

Displayed values include only those fees, costs, and hours associated with the selected providers.

1. Click the Summary tab.
2. In the Included Providers section, select the check boxes of the service providers to include.
3. Continue by viewing the total study costs with and without inflation in the Totals section.

   The values shown in the Totals section change to reflect the included providers.

View the Fees and Indirect Costs

The Totals section provides a quick way to view the total study costs broken out by direct and indirect labor fees (pass-through or miscellaneous) and with and without inflation applied.

The total applicable inflation and bottom line discount aggregated for all providers are included as separate line-items. Inflation adds to the overall fees, while any bottom line discount reduces the total labor fees.

1. After selecting the providers to include in the Included Providers section, view the values in the Totals section.

   The total study costs shown are a combination of all vender fees, pass-through costs, and sponsor internal costs.

2. Review and compare costs by grouping fees and costs.

Group the Fees and Costs

Select a grouping by which to summarize fees and costs.

1. After reviewing the fees and indirect costs with and without inflation, in the Group By section, select a way to group the fees and costs. Click the Category, Department, GL Code, or Resource button.
   Your choice determines how the values in the Fees, Hours, and FTEs and Costs sections are presented.
2. Review the fees, hours, and FTEs.

Review Fees, Hours, and FTEs

The values in the Fees, Hours, and FTEs section are displayed according to the grouping you selected.

1. After specifying the way to group fees, hours, and FTEs, view the summary in the Fees, Hours, and FTEs section.

   ClearTrial calculates the FTE (Full Time Equivalents) based on the forecasted resource effort. FTEs are based on planned resource hours and the available FTE working hours per resource.

2. Continue by reviewing the costs with and without inflation.

• FTE Calculation
  

FTE Calculation

ClearTrial calculates an FTE based on forecasted resource effort.

FTEs (or Full Time Equivalents) displayed are annual FTEs calculated by the application based on the planned resource hours required and the available FTE working hours per resource.

ClearTrial uses the level of effort estimated to complete each task per resource for each location and shows the sum of these hours per the grouping chosen (By Category, GL Code, Department, or Resource).

Monthly FTEs are calculated per month by determining the effort for a particular kind of resource expected that month and dividing by 1/12 th of the available FTE hours per year.

Annual FTEs are calculated per year by determining the effort for a particular kind of resource expected that year and dividing by the available FTE hours per year. By default, available hours per resource per year is calculated as:

• 6.5 dedicated hours per day
• x 5 work days per week
• x 50 weeks per year (accounting for minimal vacation and/or holidays)
• = 1,625 hours per year

If your organization uses a different value for the number of resource hours per year = 1 FTE, then users who are assigned the ClearTrial System Administrator primary role, can configure this for their organization by editing Customer Preferences. Customer Preferences can be launched from Start Page > Maintain > Preferences or from Admin > Customer Preferences. The preference is called "Hours per year resources are expected to perform billable work". This value will default to 1625 but you can update this value to align with what your organization uses.

Review Costs by Grouping

The total indirect costs are displayed broken out by cost category type, and with or without inflation applied.

1. After specifying the way to group costs, view the summary in the Costs section.

   Depending on the grouping, ClearTrial calculates totals with and without inflation.

2. Continue by reviewing the study dates and duration.

Review Dates and Duration

This section summarizes study-related dates and durations.

1. In the Dates / Duration section, review these dates and durations:
   • Pre-Study Activity Start Date—The date at which the earliest activity on a task or cost is expected to occur.
   • Project Activity Start Date—The date that the study is expected to begin, defined as the date that vendors or the sponsor start identifying sites and vendors start billable activity on the study.
   • Post-Study Activity End Date—The date at which the last activity on a task or study is expected to occur.
   • Study End Date—The date the study is expected to be complete, defined as the date that all activity stops. This is usually the date the final report (CSR) is finalized. It does not include any post-study follow-up by the sponsor.
   • Total Study Duration—Represents the total expected study duration in elapsed days defined as the end date minus the start date.
   • Duration of Active Treatment Phase—Represents the total expected duration of the active treatment phase (in days), defined as the Last Subject/Patient Last Treatment (LSLT/LPLT) minus the First Subject/Patient First Treatment (FSFT/FPFT).
2. Continue by reviewing the metrics associated with the study summary.

Review Metrics

This section includes the cost per completed subject and the average number of subjects per site per month.

1. In the Metrics section, review the costs per each subject who completed the study and the average expected number of subjects monitored at each site per month.

   The Number of Subjects/Site/Month value represents the average expected number of subjects monitored at each site per month, defined as the total number of subjects divided by the number of months of enrollment divided by the number of investigator sites.

   For example, 1000 subjects/12 months/10 sites = 8.33 subjects per site per month.

2. Print the summary if you wish, and then click Next to generate more detailed reports on the Reports tab.