CDMS Design Properties Reference

Lists the number of actions associated with a rule.

• Rules

Leave this checkbox selected to keep your object as Active. Clear it to make your object Inactive. Inactive objects aren’t included in extracts or executed (for rules).

• Views
• Rules

Select one or more components (Month, Day, and Time; Day and Time; or Time) from the drop-down to allow a data entry user to enter those components as Unknown. For example, for a Date/Time item, if you choose Day and Time, data entry users will be able to mark the day and the time as unknown, but not the month. Depending on when your study was originally created, you may have Month and Day or Day selected for this property. With the 19R2 release, we updated the available options for Allow Unknown. These selections will continue to work as previously, but if you edit this property, you will only be able to select from the new set of options, detailed above.

• Items with the "Date" or "DateTime" data type

For numeric fields, this dictates how Vault handles blank field values within the formula. You can choose to handle blanks As zero or As null.

• Rules

Select a Codelist Definition for the item. You can define Codelist Definitions in Studio > Codelists.

• Items with the "Codelist" data type

Use this property to configure an EDC Form for use in Vault Coder. Once configured, Vault will create a new Code Request each time a data entry user completes the Form. This property is only useable in vaults that include the Vault Coder application.

Learn more about the Coding Configuration property.

• Forms

Select a Control Type (either picklist or radio buttons) to choose how Vault displays codelist items as selectable options.

• Items with the "Codelist" data type

Select a Data Type. This indicates what type of data the Item collects on the Form. For example, if you select Codelist, the Item displays a picklist of codelist values, or a radio button for each codelist value. Depending on which data type you select, additional properties are available.

• Items

Enter the earliest (Day Range Early) and latest (Day Range Late) possible number of days before and after the Planned Date (as defined by the Offset Event and Offset Days properties) for an Event. Vault uses these to create a window of possible dates for your Event, for example, “February 1 - February 14” instead of only “February 7”. When a user enters an Event Date that falls outside of this range, Vault shows a warning. If you don’t provide values for these properties, Vault uses a single date as the Planned Date for your Event.

• Events
  (Available when the Event is associated with an Event Group)

Use this property to allow Vault EDC to automatically create a set number of repetition sequences for this Item Group, based on the selected Codelist Items. For example, if you have a repeating Physical Exam item group, you can set the Default Data property such that Vault EDC automatically creates five Physical Exam item groups (one for each Body System codelist item) each time a user creates a Form containing this Item Group.

Learn more about the Default Data property.

• Item Groups
  (For Item Groups with the Repeating property checkbox selected)

In this free-text field, you can enter a description of your object record. This is for informational purposes only and does not display outside of Studio, except for Rules. Rule descriptions display in EDC Tools > Rules.

• Event Groups
• Events
• Forms
• Item Groups
• Items
• Codelists
• Units
• Rules
• View Sets
• Views
• Review Plans
• Assessments

Select Form or Grid to determine how repeating Item Groups display in view mode to data entry users.

Learn more about the Display Format property.

• Item Groups

Select this checkbox to use this Event or Form in an Add Event or Add Form rule. If you do not select the Dynamic checkbox, you cannot reference that object in the rule.

• Events
• Forms

Select whether to add the dynamic Event or Form to only the current Event, the current Event Group, or across all identifiers.

• Rules

Indicates whether or not the Review Plan has review required for Event Dates, whether Required or No Review.

• Review Plans

Use this field to indicate whether your Event Group represents Unscheduled events. EDC, the default selection, indicates that the event group is scheduled.

• Event Groups

Select an Event Type here (EDC, Unscheduled, Screened, Enrolled, Log). For Screened and Enrolled type Event Groups, once all forms in that group are complete for a subject, the subject moves to the Screened or Enrolled status.

• Events

This field displays the formula you used when creating your Rule. You can click edit the rule expression from the Rule Editor.

• Rules

The External ID (formerly known as OID) is a description of your object record for use in data export, data migration, and external integrations.

• Studies
• Event Groups
• Events
• Forms
• Item Groups
• Items
• Codelists
• Units
• Rules
• View Sets
• Views
• Review Plans
• Assessments

Select a Form to apply the rule to. This is only required when the rule expression or action contains @Form identifiers or the rule uses the Override Review Plan, Set Item Value, or Send Email rule action types.

• Rules

Select the Future Date checkbox to generate a query any time a data entry user enters an event date that is later than the current date.

• Events
  (Available when the Event is associated with an Event Group)

The Skip Intentionally Left Blank and Did Not Occur values checkbox controls whether Vault skips data points marked as Intentionally Left Blank or Did Not Occur when determining the previous event. This is enabled by default. If you choose Schedule for Sort Events By, you can choose to clear this checkbox.

• Rules

Use this field to provide help content for your object. This text displays as a hover card and persists in the Help Content property.

• Forms
• Items

The label you enter here displays to the right of the Item field when a user edits the Form. Once a user enters a value for that Item, this label also displays on the Form in view mode.

• Items

Use this property to set the indentation level of this Item. Select 0, 1, 2, or 3. 0 indicates no indentation, and 3 indicates the most indentation.

• Items

Select an Item Type here (EDC, Status, Header, Read-only, Derived, Reference, Lab). EDC-type Items display regularly on a Form. Header-type Item values display in the subject information header. Read-only-type Items are not editable, and only display when a Form is in View mode. Reference and Lab-type Items are specific to Labs usage.

• Items

Use this field to provide a longer, detailed name for your object. For example, enter a question as a label. Event Group, Event, Form, Item Group, and Item labels display in EDC. Codelist and Unit labels only display in the Studio area.

• Event Groups
• Events
• Forms
• Item Groups
• Items

The Label for default display is the Label as applied to the Item Definition. Use this field to provide a longer, detailed name for your object definition. For example, enter a question as an item label. This property is required.

• Event Groups
• Events
• Forms
• Item Groups
• Items

This optional Label property overrides the Label (Default Display) property. This Label applies to the relationship between the object definition and its parent (for example, Form and Event). Use this field to provide a detailed name for your object definition that is specific to this use. If you reuse this object definition elsewhere in your study design, that object definition will not reference this Label.

• Event Groups
• Events
• Forms
• Item Groups
• Items

Select a Label Type to indicate the purpose of your label item (Informational, Description, Warning, or Help).

• Items with the "Label"data type

Enter the maximum number of characters.

• Items with the "Text" data type

Enter the number of digits allowed (to the left of the decimal point).

• Items with the "Number" or "Unit" data type

Enter the maximum (latest) allowable date value for the Item.

Using this property creates a system-managed Rule. Learn more.

• Items with the "Date" or "DateTime" data type

Enter the maximum allowable value for the Item (as a number).

Using this property creates a system-managed Rule. Learn more.

• Items with the "Number" or "Unit" data type

Enter the minimum (earliest) allowable date value for the Item.

Using this property creates a system-managed Rule. Learn more.

• Items with the "Date" or "DateTime" data type

Enter the minimum allowable value for the Item (as a number).

Using this property creates a system-managed Rule. Learn more.

• Items with the "Number" or "Unit" data type

This is the value you entered in the Name field when creating the object record in Studio.

• Studies
• Event Groups
• Events
• Forms
• Item Groups
• Items
• Codelists
• Units
• Rules
• View Sets
• Views
• Review Plans
• Assessments

For Offset Days, enter the number of days that the Event is offset from the chosen Offset Event. Then, if you chose Specific Event for Offset Type, select an Event Group and one of its Events that occurs before the current Event for Offset Event Group and Offset Event. If you choose Previous Event for Offset Type, Vault uses the previous event in the schedule. Vault uses these properties to create a Planned Date for your Event (or the basis of a range of dates). For example, if your Baseline Visit event is offset by 20 days from your Enrollment Visit, Vault sets the Planned Date for the Baseline Visit to be 20 days after the actual date of the Enrollment Visit. If you would like your event’s planned date to be a range of possible dates, use the Day Range Early and Day Range Late event window properties.

Learn more about the Offset Days & Offset Event Group/Event property.

• Events
  (Available when the Event is associated with an Event Group)

Select an Offset Type to determine if you will offset the Event from a Specific Event or the Previous Event in the study schedule. If you don’t want to configure an event window, select None.

Learn more about the Offset Type property.

• Events
  (Available when the Event is associated with an Event Group)

Select Yes to have Vault automatically open a query against an Event Date that falls outside of the specified event window. Select No to not create system queries on out of window event dates. By default, this is set to Inherit, meaning that Vault will or will not create queries based on the Open Query on Out of Window Event Dates study setting.

Learn more about the Open Query property.

• Event
  (Available when the Event is associated with an Event Group and an Event Window is configured)

Enter the number of days past an event’s Actual Date that the Forms within that Event become overdue.

• Events
  (Available when the Event is associated with an Event Group)

Enter the number of decimal places allowed (to the right of the decimal point).

• Items with the "Number" or "Unit" data type

Select this checkbox to append the Display Label of your Event Group to each Event. For example, Cycle (1) - Visit 1, Cycle (1) Visit 2, Cycle (2) - Visit 1, et al. This checkbox is selected by default.

• Event Groups
  (For Event Groups with the Repeating property checkbox selected)

Use this property to configure progressive display for an Item. You can use progressive display to either show or enable an Item based on the value of another codelist- or boolean-type Item.

Learn more about the Progressive Display property.

• Items

Use this field to set a maximum number of times an Event Group, Form, or Item Group can repeat.

• Event Groups
• Forms
• Item Groups

Select this checkbox if your Event Group, Form or Item Group is repeating.’

• Event Groups
• Forms
• Item Groups

Select this checkbox to restrict a Form. When a form is restricted, only users with the Restricted Data Access permission can view it.

Learn more about the Restricted property.

• Forms

The review task, either SDV or DMR, associated with the Review Plan.

• Review Plan

When you select the Post-save Rule checkbox, this property marks a query-type rule for delayed execution. This means that Vault puts it into a queue for processing after form submission, instead of processing it right away.

Learn more about the Rule Execution property.

• Rules

Select the Within Current Event Group checkbox on an Add Event, Add Form, or Add Item type rule to add the Event, Form, or Item only within the current Event Group.

• Rules

Select this checkbox to allow this View Set to be used for generating SAS exports.

• View Sets

Enter an SDTM Name (Study Data Tabulation Model) in this field. Vault uses this value for data export and external integrations. SDTM is a standard for structuring clinical study data that is defined by the Clinical Data Interchange Standards Consortium (CDISC).

• Item Groups
• Items

The type or inteded purpose of your View Set. This property is only informational. You can use it to indicate the purpose of View Sets in the listing, but no special function is tied to any type.

• View Sets

Use this field to set a shorter or abbreviated label for your object. Short labels are mandatory fields that need to be set manually. Vault EDC displays the short label in some areas instead of truncating the Label, for example, in the Form Carousel. This is useful for longer shortnames where truncation may make the name unclear. Upon object creation, Vault truncates the Label to 40 characters for use as the Short Label. You can modify this with your own shorter labels as needed. If a user clears the Short Label field, resulting in an empty value for this property, Vault displays the full Label instead of any truncated version.

• Events
• Forms
• Items

The Short Label for default display is the Short Label as applied to the Item Definition. Vault displays this Short Label by default. Use this field to set a shorter or abbreviated label for your object. This property is required.

• Events
• Forms
• Items

This optional Short Label property overrides the Short Label (Default Display) property. This Short Label applies to the relationship between the object definition and its parent (for example, Form and Event). Use this field to set a shorter or abbreviated label for your object definition that is specific to this use. If you reuse this object definition elsewhere in your study design, that use will not reference this Short Label.

• Events
• Forms
• Items

Use this property to choose which sort order Vault uses when determining the previous Event for rules. You can sort by Event Date or by Schedule (order as designed in Studio).

• Rules

You can set an object record’s Status to Active or Inactive. While you can configure Inactive objects, only Active objects are available for use in a study.

• Event Groups
• Events
• Forms
• Item Groups
• Items
• Codelists
• Units
• Rules
• View Sets
• Views
• Review Plans
• Assessments

The Study Status indicates the status of the study as it progresses, including options such as Planning and Execution.

• Studies

Select a Unit Definition for the item. You can define Unit Definitions in Studio > Units.

• Items with the "Unit" data type

Select a Unit Type. This indicates what the unit is measuring.

• Units

Enter a value for View Grouping to display in the Grouping column of the Views listing. This property is only descriptive. You can use it to visually indicate relationships between Views, but no special function is tied to groups.

• Views

The View Set Definition containing this View Definition.

• Views

Select this checkbox to display the Label value above the Item Group in form view.

• Item Groups

Select this checkbox to display a border around the Item Group in form view.

• Item Groups

Select Yes to receive a notification when a form link is required.

• Forms