Building a Study Schedule


From Studio > Schedule, you can drag and drop object definitions from the Components panel onto the Design palette to design your study schedule and forms.

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.

Using Studio > Schedule

The Schedule page is divided into two main areas: the Components panel and the Design palette. The Components panel allows you to select from the study object records you created elsewhere in Studio (such as Event Groups and Forms). You can drag and drop those components onto the Design palette in order to build your study schedule. The order in which you place components onto the palette is the order they appear in the Casebook.

Components panel & Design palette

Add Components to the Schedule

To add a component to the design palette, click and drag it from the Components panel to the Design palette. When you can drop your component, you’ll see a green line or a green plus (+) with an orange highlight.

Dragging an Adverse Events Form onto the Design palette

To add multiple Events to an Event Group, or multiple Items to an Item Group, you can drag and drop your object definition just below the previous one, while still inside the dotted line boundary of the group.

You can reorder your object definitions by clicking the shaded top-left corner and dragging the object definition to a new location on the design palette.

Collapse & Expand

You can collapse and expand components to easily view all of your components at once. To collapse all components, click the Collapse button on the design palette. This collapses all components into their Event Groups. Click Expand to return to your regular view.

You can also collapse and expand individual components. Click the Arrow button in the component header to collapse or expand a component.

How to Build your Study Schedule

After creating all of your object definitions, you can use them to design your study schedule. Open Studio > Schedule to build your schedule and forms.

To add your Event Groups and Events to your study schedule:

  1. Open Studio > Schedule.
  2. Click Event Groups to see a list of all the Event Groups available for your study.
  3. Click and drag the first event group in your study onto the design palette. When you can drop your event group, a green plus (+) displays on your cursor.
  4. Click and drag the next event group onto the design palette. Repeat this step for each additional event group.
  5. Remove the Event Groups filter and click Events.
  6. Click and drag your first event into your first event group. An Event must be within an Event Group.
  7. Click and drag the next event onto the design palette, and then drop it onto an Event Group. To place the Event in the next Event Group, repeat step 5.
  8. Repeat steps 5 and 6 for all of your Events.
  9. Optional: Click the Trash icon to remove Event Groups and Events from your schedule. Note that this does not delete the object definitions. This only removes that object from the design palette and the study’s schedule.

Now that you have added your Event Groups and Events to your schedule, you can add Forms to each Event.

To add your Forms to your Events in your study schedule:

  1. Remove the Events filter and click Forms.
  2. Locate your first Form in the list. You can search for forms as needed. Use the Name of the Form as your search term.
  3. Click and drag your first Form into your first Event. A Form must be within an Event.
  4. Click and drag any additional Forms for that Event below the first Form. When you can drop a Form, Studio displays a green line.
  5. Repeat steps 2 and 3 for all of your Forms.
  6. Optional: Click the Trash icon to remove Forms from your schedule. Note that this does not delete the object definitions. This only removes that object from the design palette and the study’s schedule.

From Studio > Schedule, you can also design each of your forms by adding Item Groups and Items to each Form.

  1. Click the Pencil icon on a form.
  2. Click Item Group to view a list of available Item Groups from your Study.
  3. Click and drag your Item Groups onto the design palette.
  4. Remove the Item Groups filter and click Items.
  5. 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.
  6. You can click Schedule to return to your event schedule without closing a form. You can also click the X to close your form’s tab.

Once you have set up your schedule and designed all of your forms in Studio, Vault EDC uses your study design when an Investigator clicks + New Casebook.


Dynamic Study Design with Rules

You can configure rules to conditionally add Event Groups, Events, and Forms to your Casebook. For example, you can configure a rule that conditionally enables the Pregnancy Test form based on the entered value for the Gender item.

See Creating Rules in Studio for details about creating rules for dynamic study design.

Dynamic Fields

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.

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.

Users with the Vault Owner security profile or CDMS Study Designer study role can perform all actions within Studio by default. If your vault uses custom_ Study Roles_, your role must grant you access to the Studio tab and your security profile must grant you permission to create and edit records in all design and study objects.


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