3 Plans

After a study has been added to ClearTrial, one or more plans can be created based on that study.

Working with Plans

Plans are created on the Plan List Screen. While editing plans, there are several tabs that allow you to enter assumptions about various aspects of a study. These tabs include: Overview Tab, Locations Tab, Site Tab, Subject Tab, Treatment Tab, Data Tab, Monitoring Tab, Provider Tab, Translations Tab, Meetings Tab, Assignment Tab, Labor Tab, Costs Tab, Payments Tab, Summary Tab, and Reports Tab.

There are entry fields in several sections on each tab. The number of fields displayed depends on which Edit Mode you are in. The Edit Mode can be controlled from the drop down box in the upper-right hand corner.

Entering Notes

To help communicate further clarification related to your input assumptions, you can use the ClearTrial notes function.

To record notes with your plan, click the Notes button in the upper right corner of each tab. Use Public notes to share with your business partners. Private notes may be limited to share with only your internal team. All notes appear on the Assumptions Report (see Reports Tab), below the table of assumptions for each functional area. You can control whether public and private notes are displayed when you print the Assumptions Report.

Warnings and Advice

The ClearTrial software provides warnings and guidance as you enter assumptions about a plan. This information is based on ClearTrial's industry information. Advice is available when a symbol appears to the right of a value. Double click the symbol to read the advice.

A blue “i” means additional information is available.
A yellow “!” indicates that a value or piece of data may be outside of standard ranges.
A red “!” signifies an entry is invalid.

Edit Modes

ClearTrial allows you to plan your studies in one of four Edit Modes, which are Quick, Basic, Advanced, and Expert. An Edit Mode controls how many input questions are displayed. Your current Edit Mode is shown in the upper right corner of the page when you are editing a plan. To change it, click on the drop down menu to select a different mode.

Quick Mode: Quick Mode displays the least amount of input questions, which is helpful when you have minimal information about a study you are planning.
Basic Mode: Basic Mode allows you to input information for all of the same fields as Quick Mode, with some additional fields.
Advanced and Expert Modes: Advanced and Expert Modes include all of the same fields as Basic Mode. These modes enable you to control all of the ClearTrial input assumptions to customize the operational approach and budget for your study. These are typically used prior to submitting an RFP bid, or for a final budgeting exercise, when you have specific information about how the study will be conducted.

Preferred and Maximum Edit Modes

You have a Preferred Edit Mode and a Maximum Edit Mode, which are set when your user account is added to ClearTrial. Your Maximum Edit Mode is the highest edit mode you are authorized to use. Contact your System Administrator to request a change to your Maximum Edit Mode.

ClearTrial defaults you to your Preferred Edit Mode every time you create a new study or plan. You can change your Preferred Edit Mode by using the Edit Profile button.

To change your Preferred Edit Mode:

Login to the application.
Select your name on the menu bar.
Click Edit Profile button.
Choose your Preferred Edit Mode from the drop-down menu and click Save.

Preferred Home Page

You have a preferred home page that is set when your user account is added to ClearTrial. The preferred home page is the screen you will view upon logging into ClearTrial. You can edit your preferred home page by editing your user profile.

To change your Preferred Home Page:

Login to the application.
Select your user name in the upper right corner.
Click the Edit Profile button.
In the Preferred Home Page drop down, select your desired home page and click Save.

Preferred Locale

You have a preferred locale that is set when your user account is added to ClearTrial. The preferred locale determines how dates and numbers are displayed within ClearTrial. You can edit your preferred locale by editing your user profile.

To change your Preferred Locale:

Login to the application.
Select your user name in the upper right corner.
Click the Edit Profile button.
In the Preferred Locale drop down, select your desired locale and click Save.

Creating Plans

To create a new plan:

Navigate to the Plan List Screen.
Click the New button.
Select the study for which you are creating a plan. You must also select a template to use as a starting point for your plan.
Click Ok. The Create Plan page is displayed, with the Overview Tab open. All of the tabs are unavailable, except for the Overview Tab. The tabs become available as information is entered.
Enter a name and description for your plan.
Complete the fields on the Overview Tab.
Input the assumptions for your plan in the series of tabs down the left side of the page. Use the Next button to navigate from one tab to the next. The plan is complete once you have reached the Summary Tab.

Saving Plans

ClearTrial allows you to save plans while you are editing them. You can save plans by clicking the Save button at the bottom of each tab, or you can click the Next button to save your work and navigate to the next tab.

Editing Plans

To edit a plan:

Navigate to the Plan List Screen.
Select a plan and click the Edit button to view the Edit Plan Screen. From the Edit Plan Screen, you can work with all of the tabs and adjust all plan assumptions as needed.

Deleting Plans

To delete a plan:

Navigate to the Plan List Screen.
Select one or more plans and click the Delete button.

Copying Plans

To copy a plan:

Navigate to the Plan List Screen.
Select a plan and click the Copy button. Enter a new name for the copied plan.

Note:
Do not select “Copy as Template,” if you want to be able to work with the copied plan. If you need to create a template, see Chapter 4, "Templates".
Click OK to view the Edit Plan Screen.

Restoring Plans

To restore a plan:

Navigate to the Plan List Screen.
Select one or more plans. If needed, adjust the filter to display deleted plans.
Click the Restore button.

Comparing Plans

To compare plans:

Navigate to the Plan List Screen.
Select two or more plans you wish to compare and click the Compare button.
Specify the information to include in the report. The information available for comparisons include: Assumptions, Fees and Costs, Fixed Unit Prices, Resources, and Milestone Dates. You can include provider details, location details, and inflation.
Select a currency and Click OK to view the comparison.

Locking Plans

If you need to prevent other users from editing a plan, you can lock the plan with the Other Actions button. You can also lock plans to prevent them from being updated with each new release of ClearTrial when there are task and algorithm changes.

Note:

You cannot lock a plan that is “incomplete.” Locked plans can be copied and the copy uses the current algorithms and calculations.

To lock a plan:

Navigate to the Plan List Screen.
Select one or more plans to lock.
Click the Other Actions button at the top of the list and select Lock Plan. A locked symbol appears next to any plan that is locked. These plans are available for viewing, but cannot be changed.

To view the version of ClearTrial that the plan is locked to, hover your mouse over the locked symbol. Information about which version of ClearTrial the plan was locked in is displayed.

Unlocking Plans

Plans that have been locked can be unlocked to be updated with the current algorithm and task changes.

Navigate to the Plan List Screen.
Select one or more plans to unlock
Select “Unlock Plan” from the Other Actions menu. The lock symbol is removed from your plan(s) and recalculated with any updated task and/or algorithm changes in the current release of ClearTrial.

Editing Attributes of a Locked Plan

The status and long description of a locked plan can be edited from the Plan List Screen, without unlocking the plan.

To edit attributes of a locked plan:

Navigate to the Plan List Screen.
Select a locked plan to edit.
Click the Other Actions button and select “Change Attributes” from the menu. Edit the plan status and long description as needed. Click Save.

View, Print, and Export a Plan

After you enter all of your plan assumptions, you can view the results and generate reports. Plan results can be viewed on the Summary Tab. Reports can be exported and printed from the Reports Tab.

To view plan results:

Navigate to the Plan List Screen.
Select the plan for which you want to generate a report.
Click the Edit button and navigate to the Reports Tab.
Select a report and specify the information you need included. Click OK and the report will be generated. From the report screen, you can print the report, view it as a PDF, or export it to a CSV or Excel file format.

Freezing Billing Rates for a Plan

ClearTrial allows you to freeze billing rates for plans, while allowing changes to other input specifications. This should be done prior to new releases of ClearTrial if you do not want your billing rates to be updated with the release.

To freeze a plan:

Navigate to the Plan List Screen.
Click the check box for the plan(s) for which you want to freeze the billing rates.
Click the Other Actions button and select “Freeze Billing Rates” from the menu. Any updates or changes to your Service Provider billing rates will not affect the output of these frozen plans.

Recalculate a Plan with Service Provider Billing Rates

ClearTrial allows you to recalculate plans with updated billing rates by unfreezing plans that were previously frozen. Plans should be unfrozen prior to new releases of ClearTrial if you want your billing rates to be updated with the release.

To unfreeze a plan:

Navigate to the Plan List Screen.
Select the plans you want to recalculate.
Click the Other Actions button and select “Unfreeze Billing Rates” from the submenu. These plans will now use the most current billing rates for the rate year specified in the Service Provider detail page.