Add Your Assumptions

Once you have selected the template and clicked Ok, ClearTrial displays the Create Plan screen.

The assumptions you can specify are grouped by category and each category is a separate tab. You can select the tabs in any order or enter your assumptions tab by tab, clicking Next to save your changes and advance to the next tab.

The first tab is the Overview tab. Any time you open or create a plan, the Overview tab is selected.

ClearTrial provides default values on each tab, but you can override these values. Some defaults vary by phase, therapeutic area, and indication, while others are dynamically updated based on your other choices specific to the plan.

• For more information about any field, click the field label to display context-sensitive help.
• For details on how your assumptions interact and can be configured to accomplish specific study goals, step through each tab section.

• Edit Basic Information on the Overview Tab
  The Overview tab includes general information about the plan such as start date, outsourcing options, currency selected, and exchange rates.
• 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.
• 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.
• Define Trial Characteristics on the Treatment Tab
  On the Treatment tab, you can define various operational trial characteristics per treatment arm.
• Select Data Management Options on the Data Tab
  You specify how data is to be collected and managed for your study on the Data tab of a plan.
• Review and Adjust Monitored Data on the Monitoring Tab
  On the Monitoring tab you can specify information about the global and by location monitoring assumptions in a plan.
• Add Vendors and Service Providers on the Provider Tab
  On the Provider tab, you can add vendors to the list of possible service providers to use and designate a primary provider to which outsourced tasks are automatically assigned. However, you make the assignments to service providers on the Assignment tab.
• Set Up Meeting Details and Attendees on the Meetings Tab
  On the Meetings tab, add or remove meetings, specify meeting details and attendees, add notes for each meeting, and estimate meeting costs.
• Define Outsourced Tasks on the Assignment Tab
  On the Assignment tab, select which location the assignments apply to and a default service provider for outsourced tasks, then, for each task or assignment group, assign a service provider and billing rate location.
• View Major Tasks and Adjust Labor Fees on the Labor Tab
  On the Labor tab, review the major tasks in the plan and adjust the calculated labor unit costs and unit hours for each service provider if necessary.
• Configure Indirect Costs on the Costs Tab
  By default, the Costs tab of a plan displays the pass-through and miscellaneous costs calculated for the plan. Some of these costs are pre-calculated. Other costs are displayed as place-holder costs based on ClearTrial's embedded intelligence.
• Define Provider Payment Schedules on the Payments Tab
  On the Payments tab, you can configure the payment schedule for each provider performing work. Payments are defined as percentage values representing the portion of the total fees paid or received at the completion of each milestone.
• 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.
• Run Reports on the Reports Tab
  The Reports tab provides a list of reports grouped by reporting category, or as thumbnails, so you can quickly and easily identify or distinguish a particular report.