Designing Forms

From Studio > Schedule, you can drag and drop design definitions from the Components panel onto the Design palette to design your Forms. You can also perform additional, display-related configuration on your Item Groups and Items in the Properties panel.

Accessing Studio

To access the Studio study design and configuration area, click the Studio tab in the primary navigation bar.

Access Studio from the Studio tab

Once you click the Studio tab, Vault opens the My Studies page, a listing of Studies in your vault. By default, this page shows automated deployment studies. You can select the Manual radio button to show your manual deployment Studies (those studies created prior to the 19R3 release that have not been upgraded to automatic deployments), or navigate to those manual studies directly from the breadcrumb menu.

Use the Automatic and Manual buttons to switch the deployment types
Use the Automatic and Manual buttons to switch the deployment types

From the My Studies page, you can click a Study Master to open the Study Instances page. Then, you can click a Study Instance to open Studio for that instance. For manual deployment Studies, clicking the Study opens the Studio area for that study right away.

How to Add Items (Questions) to a Form

An “item” represents a question, or field, on your Form. Items are grouped into Item Groups. You can add Item Groups to your Form, and then add Items to those Item Groups.

  1. In Studio > Schedule, locate the Form you want to design.
  2. Open the form layout in Edit mode:
    • If you’re using the Drag & Drop Editor, click Edit Form () on the Form. Vault opens the Form in a new Form Tab. Edit Form button

    • If you’re using the Time & Events Schedule Editor, click the Form Name to open the Drag & Drop Editor for the Form.

  3. Click Item Group to view a list of available Item Groups from your Study.
  4. Click and drag your Item Groups onto the design palette.
  5. Remove the Item Groups filter and click Items.
  6. Click and drag your Items into an Item Group. Items must be within an Item Group. You can create a two-column layout by dragging an Item to the left or right of another Item. When you can drop the item, Studio displays a green line. For example, you can place items for Systolic Blood Pressure and Diastolic Blood Pressure next to each other. Adding an Item

  7. You can click Schedule to return to your event schedule without closing a form. You can also click Close () to close your form’s tab. Close Form Tab button

When designing Forms later on, if you add an Item Group that you previously added Items to, Vault automatically adds those Items when you add the Item Group.

Progressive Display

You can use progressive display to conditionally show or enable Items based on the value entered for a codelist- or boolean-type Item on the same Form.

For example, on an Adverse Event form, you may have an Is the Adverse Event Ongoing item and an End Date item. If the event is ongoing, there is no end date to record for the adverse event. So, you can configure progressive display on the End Date item to only show it if hte user selects No for Is the Adverse Event Ongoing item.

How to Enable Progressive Display

If your Study was created after the 20R1 release (April 2020), the Progressive Display feature is already enabled. If your Study was created before the 20R1 release, you must enable this feature for your Study.

To use Progressive Display, your Study must be using the automated deployment model, and Role by Study must be enabled for your vault.

Note that you can’t enable Progressive Display if your Study contains any Disable rule definitions.

To enable Progressive Display:

  1. Navigate to Admin > Business Admin > Study Configurations.
  2. Locate your study’s Study Configuration record.
  3. Click to open the Study Configuration record.
  4. Click Edit.
  5. In the Rules Version field, enter “2”.
  6. Click Save.

Upon save, Vault does the following:

  • Adds the Progressive Display section to the Properties panel for Items in Studio > Schedule
  • Removes the Disable rule action from the Rule Editor

How to Configure Progressive Display

To configure progressive display for an Item:

  1. Navigate to your Form in Studio > Schedule.
  2. Click to open the Properties panel for the Item you want to progressively display.
  3. Click Edit.
  4. In the Progressive Display section, click Edit. Vault opens the Progressive Display dialog. Progressive Display Edit button

  5. Select a Controlling Item. Vault uses this Item value to determine whether or not to display the dependent, progressively displayed Item. Note that you can only select an Item that uses the boolean or codelist data type. Select a Controlling Item in the Progressive Display dialog

  6. Select a Controlling Item Value. When the controlling Item has this value, Vault displays the dependent, progressively displayed Item.
  7. Select a Display Type. See more details about these options below. Progressive Display dialog

  8. Click Save and close the Properties panel.

Once you click Save, Vault creates a new, system-managed rule with the Progressive Display action. Note that you can’t edit this rule from the Rule Editor. To make changes, you must edit the Item from Studio > Schedule.

You can easily identify which Items are subject to progressive display using the Progressive Display Indicator ().

Progressive Display Indicator

Progressive Display Types

There are two display types: Show and Enable.

Show When the controlling Item has the chosen value, Vault displays the Item on the form. Otherwise, the Item is completely hidden. Data entry users can’t see it.
Enable When the controlling Item has the chosen value, Vault enables the Item. When the Item is not enabled, either before a value is entered for the controlling Item or if the entered value doesn’t match the chosen value, the Item still displays on the Form but it isn’t editable.

How to Delete Progressive Display

To delete the progressive display configuration from an Item:

  1. Navigate to the Item in Studio > Schedule.
  2. Click the Item to open the item’s Properties panel.
  3. In the Properties panel’s Progressive Display section, click Edit.
  4. In the Progressive Display dialog, click Delete. Delete progressive display

  5. In the Delete Configuration confirmation dialog, click Delete.

Vault deletes the progressive display configuration from this Item. This Item will now display and be enabled automatically.

Indent Items on a Form

You can indent Items on a Form to arrange those items as a nested list. Each Item can be indented up to three (3) levels. Indentation is available for both single- and double-column layouts. For composite rows, the row’s indentation level depends on the first (leftmost) item in the row.

Using item indentation moves the data entry control from the right of the item’s label to below it.

How to Indent Items

To indent an Item using the Indent Level property:

  1. Navigate to your Form in Studio > Schedule.
  2. Click to open the Properties panel for the Item you want to indent.
  3. Click Edit.
  4. For Indent Level, select 1, 2, or 3 to set the indentation level. 1 is the least amount of indentation, while 3 is the greatest. Indent Level property with 3 selected

  5. Click Save and close the Properties panel.

Studio shows an item’s Indent Level with the Indent Level Indicator. These are stripes across the Item row, the number of which corresponds to the Indent Level. If the Indent Level Indicator is absent, this means that there is no indentation and the item’s Indent Level is 0.

Indent Level Indicator

What Data Entry Users See

See the screenshot below to see what each indentation level looks like for data entry users (investigators and clinical research coordinators).

Indented items

Conditionally Enable Item Groups & Items

If you don’t have Progressive Display enabled in your Study, you can use the Disable _rule action to conditionally enable _Item Groups and Items, based on user-entered data.

You can configure data validation rules to conditionally enable an Item or Item Group based on the entry for another Item. For example, you can configure a rule that conditionally enables the Pregnancy Test Result item based on the Gender item.

Dynamic fields only display when a user enters the correct data on a previous Item. If the user enters a different value, for example, Male for Gender, Vault disables the Pregnancy Test Result item. Vault then does not create queries or tasks related to the disabled Item.

For details about creating data validation rules to conditionally enable data entry Items, see Creating Rules in Studio.

Derived Items

You can configure Derived-type Item Definitions, which display a derived value after Form submission, based on a Set Item Value rule expression. See Creating Rules in Studio for details.

Restricted (Blinded) Forms

You can restrict (blind) a Form to hide it from users who don’t have permission to access restricted data (via the Restricted Data Access permission on their Study Role).

The Restricted Data feature is only available in Studies created after the 20R2 release (August 2020).

To restrict a Form:

  1. Navigate to Studio > Forms for your Study.
  2. Locate the Form you want to restrict in the list.
  3. Click in the form’s row to open the Properties panel.
  4. In the Properties panel, click Edit.
  5. Select the Restricted checkbox.
  6. Click Save.

The following rules govern other study configurations on restricted forms:

  • You can’t include a restricted form as visible (supplemental) data for an Assessment.
  • You can’t configure a restricted form for use in Vault Coder (via the Coding Configuration property), either as the source form or for copy Indication from link.

What Data Entry & Review Users See

Data entry users who don’t have the Restricted Data Access permission will not see any Form that is restricted. If all Forms in an Event are restricted, those users can’t see the Event. If all Events in an Event Group are restricted, those users can’t see the Event Group. If all Event Groups in the Casebook are restricted, then the user can’t see the Casebook.

For users who do have the Restricted Data Permission, they will be able to interact with the restricted form normally, whether entering data or performing review tasks. These users can identify which forms are restricted by the Restricted icon.

Study Update Restrictions

After you publish the initial version of your Casebook Definition, Vault prevents you from making certain changes in any later versions you may create. If you were to make these changes, it could cause errors during the casebook amendment process.

See Study Update Restrictions for a list of disallowed changes and available workarounds.