Publishing Validation Errors & Warnings

See the information below for help troubleshooting errors and warnings that occur when validating a casebook version:

Common Error Messages

You must resolve all errors before Vault EDC will allow you to publish your casebook version. See the Action column in the table below for details on how to resolve each error.

Error No. Name Explanation Action
EA-001 Assessment references a Restricted Form

The Assessment has a restricted Form selected as visible (supplemental data). Restricted Forms are not allowed as supplemental data for assessments.

  • Remove the restricted Form from the list of visible forms.

  • If the Form was marked as restricted in error, clear the Restricted checkbox on the form.

EBOS-001 Blank Event Group

The Event Group doesn’t contain any Events. The Event Group Definition - Event Def (event_group_def_event_Def__v) join object has no records related to this Event Group Definition (event_group_def__v).

  • Remove the Event Group from the casebook version.

  • Add Events to the Event Group from Studio > Schedule.

EBOS-002 Blank Event

The Event doesn’t contain any Forms. The Event Definition - Form Definition (event_def_form_def__v) join object has no records related to this Event Definition (event_def__v).

  • Remove the Event from the casebook version.

  • Add Forms to the Event from Studio > Schedule.

EBOS-003 Blank Form

The Form doesn’t contain any Item Groups. The Form Definition - Item Group Definition (form_def_item_group_def___v) join object has no records related to this Form Definition (form_def__v).

  • Remove the Form from the casebook version.

  • Add Item Groups to the Form from Studio > Schedule.

EBS-004 Blank Item Group

The Item Group doesn’t contain any Items. The Item Group Definition - Item Definition (item_group_def_item_def__v) join object has no records related to this Item Group Definition (item_group_def__v).

  • Remove the Item Group from the casebook version.

  • Add Items to the Item Group from Studio > Schedule.

ECB-001 Casebook Variable data type doesn't match assigned data type of Study Reference

The Study Reference uses a different Data Type than the one assigned to the Casebook Variable.

  • Update the data type of the casebook variable or the item

ECB-002 Invalid Study Reference assigned to Casebook Variable

The Study Reference no longer occurs on the study schedule.

  • Add the study reference to the study schedule.

  • Select a new study reference that appears on the study schedule.

ECB-003 Study Reference assigned to Casebook Variable cannot be in a repeating object

The Study Reference is inside of a repeating Event Group, Form, or Item Group. Study references must not be repeating.

  • Select a new, non-repeating study reference for this casebook variable.

ECC-003 Coding Configuration is copying indication from a linked restricted form

The Coding Configuration is copying the Indication from a Form Link that uses a restricted Form.

  • Update the Link to reference a form that isn’t restricted.

  • If the Form was marked as restricted in error, clear the Restricted checkbox on the form.

EE-001 Log Event on Repeating Event Group

The Event Group Definition (event_group_def__v) contains a Log-type Event Definition (event_def__v).

  • Remove the Log-type Event Definition from the Event Group Definition.

  • Change the event type from Log to EDC.

EF-001 Duplicate Common Event Form

The Study has more than one Log type event, and a single Form Definition is reused in 2 or more of those Events.

  • Remove the Form from all but one (1) of the Events.

  • Copy the Form for each Event.

EI-001 Duplicate System Rule 1

A system rule already exists for that validation property and Item combination.

  • Delete the duplicate system rule.

EIG-001 Item Group Display Format Invalid 1

The Item Group has more than sixteen (16) Items. Vault can’t display more than 16 Items in tabular (grid) view.

  • Remove Items from the Item Group until there are 16 or fewer Items.

EL-001 Indication Item Must be a Text Data Type 1

The Indication item cannot have a data type other than text because it is configured to store values from linked forms.

  • Change Indication item to a text field.

EL-002 Copy Item Must be Text or Codelist 1

The Copy Item used in form linking to copy into an Indication item cannot have a data type other than text or codelist.

  • Change Copy Item to a text or codelist data type.

EL-003 Copy Item's Item Group Cannot be Repeating 1

The Copy item’s Item Group used in form linking to copy into an Indication item cannot be a repeating item group.

  • Choose another Copy Item or move the Item to a different, non-repeating Item Group.

ER-001 Event Group Won't Display 1

The Event Group is on the schedule, but there is no Add Schedule rule that adds the Event Group to the schedule.

  • Create a rule to add the Event Group to the schedule.

  • Remove the Event Group from the casebook version.

ER-002 Orphan System Rule 1

The rule is system-generated (name starting with “R_QUERY”), but the referenced object definition’s Private Key doesn’t point to an object that any casebook version for the Study includes.

  • Remove the rule or the referenced object definition from the casebook version.

ER-003 Orphan Rule Criterion 1

THe rule points to an object definition (in the expression) that is no longer used in any casebook version for the Study.

  • Remove the rule from the casebook version.

  • Add the referenced object definition to your study’s design.

ER-004 Null Object in Rule Criterion 1

The rule has an identifier in the expression (set of Private Keys) that can’t be evaluated for that combination of keys in any casebook version for the Study.

  • Review and update the identifiers in the rule expression to match those used in the study.

  • Delete the rule.

ER-005 Null Object in Rule Action 1

The rule has an identifier in the action (set of Private Keys) that can’t be evaluated for that combination of keys in any casebook version for the Study.

  • Review and update the identifiers in the rule expression to match those used in the study.

  • Delete the rule.

ER-008 Invalid Data Type System Rule 1

The data type can’t have that validation (mask for date, range for text, etc.).

  • Remove the validation property from the referenced Item Definition.

ER-009 Null System Rule 1

The Item Definition record’s Private Key is null.

  • Update the rule so that it references an existing Item Definition.

ER-010 Invalid Rule 1

The expression contains an invalid function or operator.

  • Update the rule expression to only use valid functions and operators.

ER-017 Derived Value Data Type Mismatch 1

The value returned from the expression doesn’t match the targeted Item’s data type:

  • Text-type Items cannot accept any value.
  • Codelist-type Items can accept Text values.
  • Unit-type Items can accept Number values.
  • Update the rule so that it returns data of the expected type.

ER-018 Duplicate Rule Action Identifiers 1

The rule action contains a duplicate identifier. For rule types that allow you to select multiple identifiers, if all parts of a selected identifier match a previously selected identifier, Vault considers that identifier a duplicate.

  • Update the rule action so that it contains only unique identifiers.

ER-019 Form Cannot Be Repeating 1

The Form selected in the Rule Details panel for a Set Subject Status rule must not be a repeating Form.

  • Edit the rule and choose a new Form.

ER-020 Item Group Cannot Be Repeating 1

For the Set Subject Status rule action, you can’t use an Item within a repeating Item Group for the status change date.

  • Edit the rule and choose an Item that doesn’t belong to a repeating Item Group.

ER-021 Item Must Be a Date or DateTime 1

For the Set Subject Status rule action, you can only use an Item with the Date or DateTime data type for the status change date.

  • Edit the rule and choose an Item with the Date or DateTime Item Data Type.

ER-022 Referenced review plan doesn't exist 1

The Review Plan chosen for an Override Review Plan rule doesn’t exist. Likely, the Review Plan was removed.

  • Update the Rule to use an existing Review Plan

ER-023 Referenced Casebook Variable cannot be resolved 1

A rule’s expression references a casebook variable, and Vault can’t locate the Event Date or Item identified as the variable’s Study Reference.

  • Update the rule expression to reference the correct variable.

ER-024 Compare To data type doesn't match data type of the item reference 1

The Data Type for the Compare To field doesn’t match the Data Type of the Item Reference.

  • Update the Data Type for the Compare To.

  • Choose another Item with the correct data type.

ER-025 Orphan Form in Rule 1

The rule expression points to an orphan or invalid Form.

  • Update the rule expression to point to a valid Form that is included in the study schedule.

ER-026 Sequence number specified for non-repeating object 1

The rule expression specifies a sequence number, using square brackets ([]), for an Event Group, Form, or Item Group identifier that isn’t repeating.

  • Update the rule expression to remove the sequence number.

  • Update the rule expression to point to an identifier for a repeating Event Group, Form, or Item Group.

ER-027 No replacement value provided for item allowing unknown values 1

The rule expression references an Item that allows unknown values for date or time without providing a replacement value.

  • Update the rule expression to provide a replacement value for unknowns.

ER-028 A rule with this action type already exists 1

Only one rule with the Ready to Randomize rule action is allowed per Study.

  • Delete the second Ready to Randomize rule.

ER-029 Invalid identifier for the "Randomized" rule type 1

Rule expressions for Ready to Randomize rules can’t use wildcard (@) identifiers.

  • Update the rule expression to use a fully-qualified identifier.

ER-030 Referenced Category doesn't exist 1

The Category selected in the rule action no longer exists. The Category was deleted after rule creation.

  • Update the rule action to reference an existing Category.

ER-031 Referenced Subcategory doesn't exist 1

The Subcategory selected in the rule action no longer exists. The Subcategory was deleted after rule creation.

  • Update the rule action to reference an existing Subcategory.

ER-032 Referenced Severity doesn't exist 1

The Severity selected in the rule action no longer exists. The Severity was deleted after rule creation.

  • Update the rule action to reference an existing Severity.

ER-033 Date of Deviation reference must be a Date 1

The item reference chosen for Date of Deviation in the rule action isn’t of the date or datetime data type. The data type for the Item was changed after rule creation.

  • Update the rule action to reference a date or datetime Item for Date of Deviation.

ER-034 Expression is referencing a link that doesn't exist 1

The rule expression references a Form Link identifier that no longer exists. The Form Link existed at the time of rule creation, but it was later deleted.

  • Update the rule expression to remove the Form Link identifier.

ER-035 Sequence number must be specified 1

The reference chosen for Date of Deviation is in either a repeating Event Group (for Event Date) or a repeating Form or Item Group (for Item references), but there is no Sequence Number specified. The reference wasn’t repeating at the time of rule creation, but it was later made repeating.

  • Update the rule action to provide a Sequence Number for the Date of Deviation reference.

  • Update the rule action to point to a non-repeating reference for Date of Deviation.

ER-036 Rule missing required rule action 1

The rule doesn’t have a configured Rule Action.

  • Update the rule to add a Rule Action.

1 Vault EDC downgrades rule-related errors to warnings when a Rule Definition is Inactive.

Common Warning Messages

Vault EDC does not require you to resolve all warnings before publishing your casebook version. If you choose to resolve a warning prior to publishing, see the Action column in the table below for details.

Warning No. Name Explanation Action
WCB-01 Casebook Name Set to 1

The current Casebook Definition record’s Name is “1”.

  • Update the Name field on the Casebook Definition object record to a value other than “1”.

WEW-001 Circular Event Window

The Event Window contains a circular reference. For example, the Screening event references Enrollment for the Offset Event, but then the Enrollment event references the Screening event for its Offset Event.

  • Update the Event or Evnets so that there is no longer a circular reference.

WEW-002 Invalid Window on First Event

The first Event in the study schedule references an Event in the Offset Event property. This property must be blank on the first event in the schedule.

  • Clear the Offset Event property on the first Event in your study schedule.

WEW-003 Offset Event Not in Schedule

The event’s Offset Event selection is not in an Event Group on the study schedule.

  • Add the Event you chose for the Offset Event to an Event Group on the study schedule.

  • Edit the Offset Event to reference an Event that is within an Event Group on the study schedule.

WEW-004 Offset Event Not Available

The event’s Offset Event selection is within an Event Group that is only added to the schedule by a rule that won’t fire while the subject is in the Event.

  • Update the Offset Event selection to reference an Event that will be on the study schedule during the current Event.

WEW-005 Offset Event Invalid

The event’s Offset Event selection occurs later in the study schedule than the event.

  • Update the Offset Event selection to reference an event that is earlier than the current event in the study schedule.

WID-001 OID is not Unique (Study)

The External ID (formerly known as OID) for that object type in the Study.

  • Update the External ID value so that it is unique for that object type in the Study.

WID-002 OID is not Unique (Parent)

The External ID (formerly known as OID) for the object record is not unique within the parent object definition in the study design. For example, an item’s External ID is not unique within its parent Item Group when there are two Items with the External ID “I.DIASTOLIC_BLOOD_PRESSURE” in the Vitals item group.

  • Update the External ID value for those object definitions so that all of their External IDs are unique within the parent definition.

WIG-002 Item Group Tabular Display Contains Label

At least one Item in the Item Group has the Label item type. Vault doesn’t display label-type Items in tabular (grid) view.

  • Remove the label-type Item from the group.

  • Update the item’s Item Type from Label to another type.

WL-001 Form Link References a Non-repeating Form

The form link references a form that is not a repeating form.

  • Choose a repeating form to link forms.

WL-002 Form Link References an Orphan Form

The form link references a form that is not in the schedule because the Event Group containing the Form does not have an Add Schedule rule or the Form is dynamically added and does not yet exist.

  • Create an Add Schedule rule.

WL-003 Copy Item was Moved or Deleted

The Copy Item used in form linking was deleted, moved to another item group, or moved to another form and must be updated.

  • Update the Copy Item to reflect its current status.

WR-008 Orphan Object in View

The identifier (set of Private Keys) in the mapping to the column can’t be evaluated for any combination of keys in any casebook version for that Study.

  • Update the Column Binding to reference an object record that is used in any casebook version of the Study.

WR-009 Null Object in View

One or more parts of the identifier (set of Private Keys) in the mapping to the column is null or can’t be evaluated for any combination of keys in a casebook version for that Study.

  • Update the Column Definition in that View Definition to reference an object record that is used in any casebook version for that Study.

WR-011 Dynamic Flag Not Set

An Add Event or Add Form rule references an Event or Form that doesn’t have the Dynamic checkbox selected.

  • Update the referenced Event or Form and select the Dynamic checkbox property.

  • Update the rule to reference the correct, dynamic Event or Form.

WR-012 Dynamic Object Won't Display

An Event or Form that is marked as Dynamic doesn’t have a related Rule Definition that adds it to the Casebook.

  • Create an Add Event or Add Form rule that references the dynamic Event or Form.

  • Clear the Dynamic checkbox property on the Event or Form.

WR-016 Multiple dynamic rules on object

There are multiple dynamic rules (Add Event Group, Add Event, or Add Form) that add this Event Group, Event, or Form in the rule action. This can cause conflicts during rule execution, resulting in display issues.

  • Delete one or more rules until only one dynamic rule adds the Event Group, Event, or Form.

  • If one of the rules is a duplicate, update the Rule Action to add the correct Event Group, Event, or Form.

WR-017 Multiple Override review plan rules on form definition

A single Form is referenced by multiple Override Review Plan rules using the same review task (SDV or DMR).

  • If one of the rules is a duplicate, delete it.

  • If one rule was meant to use the other review task, update that rule.

WR-021 Rule evaluation might result in too many permutations

The rule’s expression contains multiple, fully-qualified identifiers on repeating objects. This might result in too many permutations for evaluation.

  • Simplify the rule expression to reference fewer repeating objects, or consider using wildcard (@) identifiers.

WSC-001 Missing SDV Review Plan

An SDV-type Review Plan doesn’t exist for this Study.

  • Create an SDV Review Plan for this Study.

WSC-002 Missing Signature Statement

There are no active Signature Definition object records that reference this Study.

  • Create a Signture Definition for this Study.

  • Edit an existing Signature Definition record to reference this Study.

WSC-003 Orphan Review Plan Object

The Review Plan references the Private Key of a definition object record that isn’t used in any casebook version for the Study.

  • Update the Review Plan to reference only used object records.

WSC-004 Null Object in Review Plan

The Review Plan references the Private Key of a definition object record that doesn’t exist in any casebook version for the Study.

  • Update the Review Plan to reference only existing object records.

WSC-005 Randomizing rules in studies without Randomization

Rules used in Randomization are triggered when Randomization is not configured.

  • Delete rules relating to Randomization or configure Randomization if available.

WSC-006 No _Ready to Randomize_ rule

Randomization is configured but there is no Ready to Randomize rule.

  • Create the Ready to Randomize rule.

WSC-007 Multiple _Ready to Randomize_ rules

There are multiple Ready to Randomize rules.

  • Delete additional Ready to Randomize rules.

WPD-001 The controlling item is not a codelist or boolean value

The Item chosen for the progressive display Controlling Item is not of the codelist or boolean (checkbox) data type.

  • Update the Controlling Item to an item using the codelist or boolean data type

  • Update the item’s data type to codelist or boolean

WPD-002 The codelist values have changed and can't be evaluated

The codelist item chosen for the Controlling Item Value (progressive display) has been updated or removed.

  • Select an existing codelist item for the Controlling Item Value

WPD-003 The controlling item cannot be evaluated

The Item chosen as the Controlling Item has been removed from the Form in the current casebook version.

  • Choose a new Controlling Item

  • Add the original Item back onto the Form

WLB-001 Invalid Study Reference for Casebook Variable Female Cycle

Labs is enabled for this Study, but the Female Cycle casebook variable isn’t mapped to an Item that uses the Female Cycle codelist.

  • Map the Female Cycle casebook variable to the Item that uses the Female Cycle codelist.

  • Update the mapped Item to use the Female Cycle codelist.

WE-001 Event contains only Restricted Forms

All Forms within this Event are restricted (Restricted checkbox property is selected). For users without the Restricted Data Access permission, this Event will display as a blank Event (having no Forms).

  • Add a Form that isn’t restricted to the Event.