Working with Casebooks

Vault EDC uses two objects to manage participants in a study: Subject and Casebook. A Subject record represents an individual subject participating in a Study. That subject’s Casebook object contains all other records related to the Subject for that Study.

Creating a Casebook

Creating a Casebook automatically creates a new Subject, as well as Events, Forms, and Items related to the Study. Note that the Subject ID is defined during study design.

  1. Navigate to the Casebook listing page. Casebook Listing Page

  2. Click + New Casebook. New Casebook button

  3. In the Create Casebook confirmation dialog, click Create.
  4. Vault creates the new Casebook record and opens it in the casebook schedule.

From the Casebook, you can define dates for events in your study, as well as open and fill forms.

Deleting a Subject Casebook

If you create a new subject casebook accidentally, you can easily delete it before entering any data. Note that Vault will not allow you to delete a Casebook containing data (including Event Dates).

To delete a Casebook:

  1. Navigate to the Casebook you want to delete.
  2. Verify that there is no data within the Casebook, including Event Dates.
  3. From the casebook-level Actions menu, select Delete Subject. Delete Subject action

  4. In the Delete Subject dialog, select a Reason. Delete Subject confirmation dialog

  5. Click Continue.
  6. In the confirmation dialog, type “DELETE”.
  7. Click Delete.

Vault deletes the Subject record, the Casebook, and all associated object records. This action cannot be undone.

Admin: How to Enable Casebook Deletion

By default, no roles have permission to delete a casebook. You can create or edit a Study Role (provide the Delete Casebook permission) or create a custom Security Profile and Permission Set (with the Objects: Subject: Delete permission) to allow users with that role or profile to delete subject casebooks. For details about configuring specific reason options for subject deletion, see Configuring Reasons for Change.

Viewing a Casebook

You can access existing casebooks in the Casebook listing page.

To view existing casebooks:

  1. Navigate to the Casebook listing page.
  2. Click a Casebook in the list to open.
  3. Vault opens the Casebook. You can now sort the schedule, collapse and expand Events, and click into Forms to enter data.

Casebook Header

The casebook header spans the casebook page, just below the breadcrumb navigation. The header typically displays demographic information, like Subject ID, Date of Birth, Gender, Race, and Subject Initials. Certain fields populate the header. These fields are defined and configured during study design. Hover over the Information (i) icon next to the Subject ID to see the current casebook version.

Sorting Events in a Casebook

You can sort the Events in the casebook schedule by the Planned (from the Study definition) or actual Event (user-entered) date. Use the Schedule and Event Date order options to reorder Events on your casebook schedule. Events can be expanded or collapsed through the Schedule Header in version 2 of the Data Entry UI.

Data Entry UI Version 1: Sort Events Version

Data Entry UI Version 2: Expand all Events Version 2

No matter which sorting method you use, the Event or Planned Date display along with the Event in the same manner. Note that the order of Events in the breadcrumb drop-down menu always matches the Schedule order.

Casebook Schedule

Each Casebook contains all Events and Forms for a given Subject. The Casebook displays these events and forms chronologically in the casebook schedule. Vault EDC displays Event and Form records in a tree view from Start of Study to End of Study. The casebook schedule displays only records you have permission to view.

Casebook Schedule Actions

You can perform actions on a Casebook record using the casebook schedule’s Actions menu.

  • Freeze Subject allows you to freeze the Subject.
  • Lock Subject generates a blank PDF of all forms in the casebook schedule.
  • Export Blank PDF generates a blank PDF of all forms in the casebook schedule.
  • Export Detail PDF generates a detail PDF of all forms in the casebook schedule.
  • Casebook Audit Trail opens an audit trail for the Casebook.

Sign a Casebook

Click the Sign button at the top of the page to select and sign all Completed forms. See details here.

Event Status Icons

Events in the casebook have status indicator icons. The table below orders icons by priority, from highest to lowest. For example, the Overdue status will appear on an Event in the casebook schedule, even if the Event also has the Open Query status. If you hover your mouse over any icon in the application, Vault EDC displays text with the icon’s meaning.

Icon Name Status
Overdue The Event’s due date has passed and at least one form has the Planned status.
Open Query At least one Form in the Event has an Open Query (at the form- or item-level). Vault EDC adds an Open Query badge to the Event status icon.
In Progress The Event has an Actual Start Date, and at least one form is not Submitted or has at least one task. This status can also indicate that at least one but not all Forms in the Event are frozen or locked.
Submitted All Forms in the Event are submitted and no forms have a Planned or Blank status.
Blank The Event has an Actual Start Date, but all forms are in the Planned status.
Planned The Event has no Actual Start Date.
Did Not Occur The Event is marked as Did Not Occur.

Form Status Icons

The Forms displayed in the casebook schedule also have status indicator icons. The table below orders icons by priority, from highest to lowest. If you hover your mouse over any icon in the application, Vault EDC displays text with the icon’s meaning.

Icon Name Status
Overdue The Form is in Planned status and the Event due date has passed.
Open Query Badge Icon Open Query There is at least one Open Query on an Item in the Form. Vault EDC adds an Open Query badge on top of the Form status icon.
Submitted The Form has been submitted and there are no open tasks.
In Progress Icon In Progress The Form has not been submitted since the last data change or there are tasks not completed on the Form. 
Blank The Form has not been submitted, and has no queries, autosaves, or fields left blank.
Intentionally Left Blank Icon Intentionally Left Blank A data entry user marked this Form as Intentionally Left Blank.
Locked All Items in the Form are Locked.
Frozen All Items in the Form are Frozen.

Event Actions

When viewing the casebook schedule, you can perform several actions on your events.

  • Enter and change an Actual Start Date for an Event.
  • Add an Unscheduled Event to the casebook.
  • View the Event History (audit trail).
  • Provide an eSignature.
  • Freeze and unfreeze all Forms in an Event.
  • Lock and unlock all Forms in an Event.

You can also perform actions directly on forms.

Reset an Event

Resetting an Event removes all entered data, removes the Forms associated with the Event, clears the Event Date, and closes any open queries.

To reset an Event:

  1. Navigate to the Casebook containing the Event.
  2. Locate the Event in the casebook schedule.
  3. From the event’s More Actions menu, select Reset Event. Reset Event action

  4. In the Reset Event dialog, select a Reason. Select a Reason for Event Reset

  5. Click Continue.
  6. In the confirmation dialog, type “RESET”. Type Reset in the confirmation dialog

  7. Click Reset.

Planned and Actual Dates

Before you or another user has defined an Actual Start Date for an Event, each Event displays a date range in the casebook schedule: Planned No Earlier Than to Planned No Later Than. For example, the Baseline Visit event displays the range ‘5/1/2017 - 5/5/2017.’ If there is only one planned date and not a planned range, the Event displays a single date.

To define an Actual Start Date for an event, click Enter Date and select the date from the calendar. You can also define the Actual Start Date by clicking the Down arrow on your keyboard and entering the date in the field.

Did Not Occur

If for some reason an event in your study did not occur, you can click Did Not Occur in the casebook schedule. Vault prompts you to enter a reason. Once you have marked an event as Did Not Occur, Vault does not create any forms for that event, and you can proceed to the next event in the casebook schedule.

Mark an Event as Did Not Occur

Note that you can change this status by selecting Enter Date from the event’s More Actions menu.

Changing an Event Date

To change an Event date:

  1. Select Edit Event Date from the event’s More Actions menu in the casebook schedule.
  2. Select a Reason for Change.
  3. Click OK.

Events with No Overdue Date

Events can be configured so that no Forms in that Event ever become overdue. These Forms don’t display as overdue in the task bar.

Adding New Events

Depending on your study design, Casebooks may allow for cycles, or repeating Event Groups. Repeating Event Groups allow you to add an Event Group to a Casebook multiple times. Each time you add that Event Group, it contains the same collection of Forms and Items as the previous. Each new Event Group may have a customized label, and often incremented labels, such as Visit 1, Visit 2, Visit 3, etc.

Each instance of the repeating Event Group is an Event Group sequence.

To add a new Event Group sequence:

  1. Navigate to the casebook schedule.
  2. Click + New Event.
  3. The New Event dialog opens. Select the repeating Event Group.
  4. Click Add {#} Events..
  5. Vault creates a new Event Group sequence and adds Forms to each of its Events.

You can continue to add Event Group sequences until you reach the configured Repeat Maximum (by study design).

You can delete an unscheduled event if all of the forms are blank. Choose Delete Event from the unscheduled event’s More Actions menu to remove it.

Unscheduled Events

You may need to document events that weren’t planned. You can easily create an Event record from the casebook schedule. Vault automatically creates forms for the new event. These forms are based on your study design.

To add an unscheduled event:

  1. Navigate to the casebook schedule.
  2. Click + New Event.
  3. The New Event dialog opens. Select an Event.
  4. Enter the date of the unscheduled Event.
  5. Click Add {#} Events.
  6. Vault creates a new, unscheduled Event record and adds log forms to the event.

You can delete an unscheduled event if all of the forms are blank. Choose Delete Event from the unscheduled event’s More Actions menu to remove it.

Note that adding an unscheduled event may create a single event or an event group, based on your study design. The number in the Add Events button reflects the number of events Vault creates.

Dynamic Event Groups

Your study may include data validation rules that automatically add Event Groups to a Casebook based on data that you enter.

During a study, you may enter data incorrectly or a subject’s status may change. Updates to Form values may change which Event Groups are needed for the Casebook. When the data validation rule that added the Event Group is no longer true, Vault automatically removes the Event Group if all Forms in the Event Group are blank. If any of those Forms is not blank, you must use the Reset Form action to reset the Form status to blank. Once you have reset the necessary Forms, return to the first Form with the data validation rule. Submit the Form with updated values.

Completing Tasks from a Casebook

You can easily navigate to Event and Form records associated with your Casebook from the casebook schedule.

  • Clicking on an Event opens the first incomplete Form in that Event.
  • Clicking a Form opens that Form. Once you submit a Form, Vault EDC returns you to the parent Casebook.

Once you enter a form, you can navigate to other forms in the casebook from the breadcrumb menu or from the form carousel. The form carousel displays all forms in an event. You can scroll horizontally through the form carousel by clicking the arrow buttons on each side. Click on a form to open it. The form carousel also provides links to common forms for quick access.

Form Carousel

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard CDMS Principal Investigator, CDMS Sub Investigator, and CDMS Clinical Research Coordinator application roles can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab Data Entry Tab

Ability to access the Data Entry tab

Functional Permission Add Casebook

Ability to add new Casebooks

Functional Permission Delete Casebook

Ability to delete subject Casebooks and related object records

Functional Permission Data Entry

Ability to enter study execution data

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Profile Permissions

These actions are available for the EDC Clinical Research Coordinator and EDC Investigator security profiles.