Configuring Assessments

Vault EDC’s Medical Assessments feature supports the supplemental assessment and review of relevant casebook data. Selected subject casebook data is presented in the Assessments tab for medical review to inform determinations about that data. This feature can be used to support decision-making about trial data, including decisions regarding compliance, trial eligibility or continuation, and device deficiency. The Medical Assessments feature can also be used to complement an external adjudication process or a safety system such as Vault Safety for additional high-level review. Assessment decisions and rationales are stored separately from the subject’s casebook data.

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

Creating a New Assessment

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

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.

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.

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.

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?”.

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.

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).

To set the visibility for 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.

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

Once you finish defining visibility, click Complete.

Visibility Icons

The following icons represent the visibility selection:

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

Reassessment

In the Reassessment stage, you can configure an Assessment Definition to automatically trigger a reassessment when data from the selected forms is changed.

To configure Reassessment:

1. Click the checkbox next to the forms that, if changed, should trigger a reassessment.

2. In the Set As drop-down, choose Trigger to trigger a reassessment if changes are made to the checked forms.

3. Repeat the process for forms that should not trigger a reassessment if changed but choose Will Not Trigger in the Set As drop-down menu.
4. Click Save and Close.

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.

Date

Date questions collect a date.

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.

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.

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.

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.

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.

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.

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.

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.

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

Related Permissions

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.