Configuring Assessments


Medical monitors and other users in similar roles can perform clinical assessments from within Vault EDC. Before a user can perform a clinical assessment, you must first create an Assessment Definition from Studio > Assessments, add questions to the assessment, and define visibility for supplemental data.

This feature is only available in vaults where Role by Study is enabled. If Role by Study is not enabled in your vault, contact your Veeva Services representative.

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.

Assessment Types

In the current release, Assessment Types are purely informational. These can serve as a reference for you when managing your assessment configuration.

Creating a New Assessment

There are three phases to creating an Assessment: Definition, Design, and Visibility. You can easily identify which stage of assessment creation you are currently from the Stages Chevron panel.

Assessment Design Stages Panel

Definition

In the Definition stage, you’ll create your Assessment Definition. This contains the configuration for your assessment’s design and visible supplemental data.

To create your Assessment Definition:

  1. Navigate to Studio > Assessments.
  2. Click + New Assessment. New Assessment button

  3. Enter a Label for your Assessment Definition.
  4. Optional: Edit the Name. Vault automatically creates the Name to match your Label.
  5. Select a Type. You can create a new Type by clicking + New Assessment Type in the drop-down menu. New Assessment Type option

  6. Enter a number of days for Due. This sets the Due Date of each Assessment to this number of days after the Form is submitted.
  7. Optional: Enter an External ID.
  8. Optional: Enter a Description.
  9. Click Save and Next to move to the design stage. Save and Next button

  10. Optional: Click Save to save your changes to the Assessment Definition without moving to the next stage.

Design

In the Design stage, you’ll create the questions to display on the assessment’s questionnaire. When you first enter the Design stage, Vault lists any existing Questions here.

To add questions to your Assessment:

  1. Click + New Question. New Question button

  2. Enter a Caption for your question. This is a label that displays above the question field. Typically, the Caption should be your question text. For example, “Was the Adverse Event correctly marked as Serious?”. Question dialog

  3. Click to select a Data Type. See Question Data Types below to see details about each available data type.
  4. Depending on your data type selection, different configurations are required. Fill the required fields for your question.
  5. Optional: Select the Required checkbox to mark a Question as required.
  6. Click Save.
  7. Optional: Click Save and New to save this Question and immediately create another.

Once you’ve created all of the Questions for your Assessment, you can drag and drop them to reorder them in the Questions listing. Click and drag Questions to move them.

Visibility

In the Visibility stage, you can select which Forms from the Casebook will be visible to the assessor. For example, with an Adverse Event assessment, you’ll want to make sure that the assessor is able to view the originating Adverse Event form.

To set visibility at the Form level:

  1. Select one or more Forms by selecting the Form checkbox or clicking anywhere in the form’s row.
  2. Optional: You can click the All Forms checkbox in the header to select all Forms. Select All Forms checkbox

  3. In the Set As drop-down, choose Visible to set the selected Forms as visible, or choose Hidden to set the selected Forms as hidden (not visible). Set As menu for Visibility

To set the visibility of specific Items and Item Groups on a Form:

  1. Click a Form to open it.
  2. To change the visibility of all Items at once, click the Visibility radio button in the Item Group header. Marking an Item Group as Visible

  3. To set an Item as Visible, select the Visible radio button. To mark it as Hidden, click the Visible radio button again. Marking an Item as Visible

Once you finish defining visibility, click Complete.

Visibility Icons

The following icons represent the visibility selection:

Icon Meaning
Visible icon
  • All Items on the Form are visible.
  • The Item is visible.
Some Items are Visible icon
  • Some Items on the Form are visible, but at least one Item is hidden.
Hidden icon
  • No Items on the Form are visible.
  • The Item is not visible.

Question Data Types

The following data types are available for assessment questions:

Label

Label questions are informational labels to display to assessors. These do not collect any information.

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
Label Type Select Select Informational, Description, Warning, or Help. The label displays differently depending on your selection.
Informational type label
Description type label
Warning type label
Help type label

Date

Date questions collect a date.

Date question

The following configuration options are available for date-type questions:

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
External ID Text An external ID for the question
Required Checkbox Indicates that this question is required. If selected, assessment editors will not be able to complete the assessment without answering this question.

DateTime

DateTime questions collect a date and a time.

DateTime question

The following configuration options are available for DateTime-type questions:

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
External ID Text An external ID for the question
Required Checkbox Indicates that this question is required. If selected, assessment editors will not be able to complete the assessment without answering this question.

Text

Text questions collect text-based data via a text entry field.

Text question

The following configuration options are available for text-type questions:

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
External ID Text An external ID for the question
Required Checkbox Indicates that this question is required. If selected, assessment editors will not be able to complete the assessment without answering this question.
Length Number Enter the maximum number of characters allowed for this question’s answer.

Number

Number questions collect numerical data.

Number question

The following configuration options are available for number-type questions:

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
External ID Text An external ID for the question
Required Checkbox Indicates that this question is required. If selected, assessment editors will not be able to complete the assessment without answering this question.
Length Number Enter the maximum number of digits allowed.
Decimal Number Enter the maximum number of decimal places allowed.

Radio Buttons

With a radio button question, assessment users can select one option from a set of options using a radio button control.

Radio Button question

The following configuration options are available for radio button-type questions:

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
External ID Text An external ID for the question
Required Checkbox Indicates that this question is required. If selected, assessment editors will not be able to complete the assessment without answering this question.
Selection Options Text Enter an option for the question. Click + Add New Choice to add additional options.
Inactive Checkbox Select the Inactive checkbox on a selection option to mark it as Inactive. Inactive options do not display to assessment users on new Assessments and display as disabled on existing Assessments.

Picklist

With a picklist question, assessment users can select one option from a set of options using a picklist (drop-down menu) control.

Picklist question

The following configuration options are available for picklist-type questions:

Field Type Description
Name Text A unique name for the question containing only alphanumeric characters and single underscores (_)
External ID Text An external ID for the question
Required Checkbox Indicates that this question is required. If selected, assessment editors will not be able to complete the assessment without answering this question.
Selection Options Text Enter an option for the question. Click + Add New Choice to add additional options.
Inactive Checkbox Select the Inactive checkbox on a selection option to mark it as Inactive. Inactive options do not display to assessment users on new Assessments and display as disabled on existing Assessments.

Editing Assessments

You can edit an Assessment Definition, even when your Study is already in progress. Assessment Definitions are not subject to casebook versioning.

If you edit an Assessment Definition while your Study is in progress, your changes apply to existing Assessments. Take care when making mid-study updates.

You can make high-level changes to your configuration from the Properties panel. See below.

To edit an Assessment:

  1. Navigate to the Assessment you want to edit in Studio > Assessments.
  2. Either click the hyperlinked Name or number of Questions to skip to the Design step.
  3. Make your changes.
  4. Click Save.

Assessment Editable Properties

The following are editable properties in the Properties panel for Assessments. See the Design Properties Reference for more details.

Property Description
Name A unique name for your Assessment Definition record
Type An informational grouping of Assessment Definitions
Overdue Days The number of days after the assessment’s Created Date that the Assessment becomes overdue (Field labelled Due during assessment creation)
Description A text description of the Assessment Definition (Optional)
Status The Status of your Assessment Definition record. If an Assessment is Inactive, Vault does not create new Assessments based off of this definition.

Creating Add Assessment Rules

Vault uses rules to create Assessments based on user-entered data. For example, the Deetoza study contains an Add Assessment type rule to add the “Serious Adverse Event Assessment” whenever a user selects “Yes” for “Was this adverse event serious?” on the Adverse Event form.

Create a new Rule with the Add Assessment action type for each Assessment you create. Vault will not create Assessments unless there is a rule to add them.

Inactivate & Reactivate Questions

Vault allows you to inactivate assessment questions. Once you inactivate an Assessment Question, Vault no longer creates that question when creating assessments. Any existing Assessments will continue to include that question until they are reset. Upon reset, Vault removes the inactive question. If you reactivate a question, Vault creates that question in new assessments, but does not add it to existing assessments until reset.

To inactivate an Assessment Question:

  1. Navigate to Studio > Assessments > Design.
  2. Locate the Assessment Question that you want to inactivate.
  3. From the Actions menu, select Inactivate Question. Inactivate Question action

  4. Vault inactivates your question. Inactive questions are disabled in the question list. All new Assessments will not include this question. Once any existing Assessments are reset, Vault will remove this question.

To reactivate an Assessment Question:

  1. Navigate to Studio > Assessments > Design.
  2. Locate the Assessment Question that you want to reactivate.
  3. From the Actions menu, select Reactivate Question. Reactivate Question action

  4. Vault reactivates your question. All new Assessments will include your question. Once any existing Assessments are reset, Vault will add the question.

Users with the Vault Owner security profile or CDMS Study Designer study role can perform the actions described above by default. If your vault uses custom Study Roles, your Study Role and Security Profile must provide permissions to access Studio, as well as create, edit, and delete records in the following objects:

  • Assessment Definition
  • Assessment Question Definition
  • Assessment Def - Question Def
  • Choice Definition
  • Choice Item Definition
  • Supplemental Data Object Definition

Learn more about Study Roles.