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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.0 E36710-02 |
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# 7 Entering Plan Specifications for Studies

After you have created a plan and you are ready to begin entering assumptions, you can begin entering specifications for your study with the tabs on the Edit Plan Screen. The tabs allow you to specify all information related to your study, such as data collection methods, assigning service providers, entering costs, etc.

Note: Before you can begin entering assumptions, you must create a product and study. For more information, see Section 2, "Products".

## 7.1 Plan Tabs

The Edit Plan Tabs include the following: 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.

## 7.2 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.

## 7.3 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.

## 7.4 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.

## 7.5 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:

1. Login to the application.

2. Select your name on the menu bar.

3. Click Edit Profile button.

4. Choose your Preferred Edit Mode from the drop-down menu and click Save.

## 7.6 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:

1. Login to the application.

2. Select your user name in the upper right corner.

3. Click the Edit Profile button.

4. In the Preferred Home Page drop down, select your desired home page and click Save.

## 7.7 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:

1. Login to the application.

2. Select your user name in the upper right corner.

3. Click the Edit Profile button.

4. In the Preferred Locale drop down, select your desired locale and click Save.