Publishing Validation Errors & Warnings

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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

• Delete the duplicate system rule.

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.

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.

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.

The Copy item’s Item Group used in form linking to copy into an Indication item cannot be a repeating item group. This error occurs when the Item Group was changed to repeating after the form link was set.

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

The Form Link Item’s display items are no longer valid due to being removed or set as repeating.

• Remove the linked item or remove the items from the link that are no longer available.

The Form Link Item no longer has a Linked Form populated. This error may occur if the form is deleted from the study.

• Remove the linked item or point it to a form that is available in the casebook.

The Form Link Item references a restricted form from a non-restricted form. This error occurs if the form was made restricted after the item was created.

• Remove the linked item or point to a non-restricted form.

The Form Link Item is referenced in a Coding Configuration, which is not supported.

• Update the coding configuration to point to another item on the form instead of the Form Link Item.

The form used in the Form Link is not available in the study definition.

• Remove the linked item or point it to a form that is available in the casebook.

There is a linked form but no display items. This error may occur if the form design changed on the source form and the items were removed from that form or Item Group.

• Update the form link to select items to display.

The Sex casebook variable must be associated with an item referencing the Sex codelist.

• Update the Sex casebook variable so that it’s associated with an item.

The Birth Date casebook variable must have a Date data type.

• Change the Birth Date casebook variable data type to Date.

The Birth Year casebook variable must be have a Number data type.

• Change the Birth Year casebook variable data type to Number.

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.

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.

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.

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.

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.

System rules (edit checks) are usually tied to properties that are specific to a given data type. If you update an item’s data type in a way that the property is no longer associated (for example, going from number to text removes the Minimum Value property), Vault doesn’t automatically remove the rule.

• Remove the validation property from the referenced Item Definition.

• Delete the rule.

The Item Definition record’s Private Key is null.

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

The expression contains an invalid function or operator.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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

• Delete the second Set as Ready to Randomize rule.

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

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

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.

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.

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.

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.

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.

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.

The rule doesn’t have a configured Rule Action.

• Update the rule to add a Rule Action.

An Item is changed to derived after it’s already been used in a rule. Derived items can only be used with the Set Derived Value rule action.

• Update the rule to use the Set Derived Value rule action when using derived items.

The derivation version is set to cross-form but Set Item Value rules are configured.

• Use Set Derived Value rules for cross-form derivations.

The derivation version is set to single form but Set Derived Value rules are configured.

• Change the derivation version to cross-form.

• Use Set Item Value rules for single form derivations.

A Set Derived Value rule on a verbatim or related item for Coder cannot reference forms other than @Form, the derivation target form.

• If a derived item is used as a related or verbatim item for Coder, the Set Derived Value rule(s) with Action on that derived item must only reference @Form (the target form).

The rule action contains an invalid identifier for the referenced form.

• Update the rule action to include a valid identifier.

The rule expression contains an invalid identifier for the referenced form.

• Update the rule expression to include a valid identifier.

This E2B ID must be mapped to an Item that is not in a repeating Item Group because Allow Multiple SAEs per Safety Case is set to No. This includes the following E2B IDs: E.i.3.1, E.i.3.2a, E.i.3.2b, E.i.3.2c, E.i.3.2d, E.i.3.2e, E.i.3.2f, E.i.4, E.i.5, E.i.6a, E.i.6b, E.i.7, E.i.8, E.i.9, G.k.9.i.2.r.3, and G.k.9.i.4.

• Update the mapping of the E2B ID to be in a non-repeating Item Group

• Move the Item mapped to this E2B ID into a non-repeating Item Group

This E2B ID must be mapped to an Item that is in the same repeating Item Group as the Item mapped to E.i.1.1a. This includes the following E2B IDs: E.i.3.1, E.i.3.2a, E.i.3.2b, E.i.3.2c, E.i.3.2d, E.i.3.2e, E.i.3.2f, E.i.4, E.i.5, E.i.6a, E.i.6b, E.i.7, E.i.8, E.i.9, G.k.9.i.2.r.3, and G.k.9.i.4.

• Update the mapping of the E2B ID to be in the same Item Group as E.i.1.1a

• Move the Item mapped the E2B ID to be in the same Item Group as E.i.1.1a

This E2B ID (G.k.8) must be mapped to an Item that is not in a repeating Item Group.

• Update the mapping of the G.k.8 E2B to be in a non-repeating Item Group

• Move the Item mapped to G.k.8 into a non-repeating Item Group

An Event Group, Event, Form, Item Group, or Item referenced by the Safety Configuration is not available in the latest casebook version.

• Update the Safety Configuration to reference a different object

• Add the object back into the schedule

A definition relationship (study schedule or form layout) between these two objects is referenced by the Safety Configuration but does not exist in the latest casebook version.

• Update the Safety Configuration to reference different objects

• Add the relevant objects back into the schedule

The Form directly referenced by the Rule and the Integration Definition must match.

• Update the Form for the Rule or the Integration Definition so that the two match.

The Integration Definition references study objects that don’t exist in any casebook version.

• Update the Integration Definition to reference existing study objects.

A required column (field) isn’t defined on the Integration Definition.

• Enter a value in the required column.

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”.

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 Events so that there is no longer a circular reference.

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.

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.

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.

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.

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.

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.

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.

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

• Choose a repeating form to link forms.

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.

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.

Local Labs is enabled but the Female Cycle casebook variable isn’t associated with an item referencing the Female Cycle codelist.

• Update the Female Cycle casebook variable so that it’s associated with an item that references the Female Cycle codelist.

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.

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.

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.

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.

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.

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.

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.

The Rule references an orphaned or invalid Form.

• Update the form identifier in the rule to point to an existing, valid Form.

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

• Create an SDV Review Plan for this Study.

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.

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.

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.

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

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

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

• Create the Set as Ready to Randomize rule.

There are multiple Set as Ready to Randomize rules.

• Delete additional Set as Ready to Randomize rules.

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.

Any repeating object definitions (event groups, forms, or item groups) in the Set Subject Status rule action identifiers must have a sequence number specified.

• Edit the rule and specify a sequence number.

Derived rules are creating a circular reference between items.

• Edit relevant rules to prevent derived rules from linking back to the form that initiated the update of derived values.

The Subject Status rule action identifier cannot contain “this event group”, “this event”, or “this form”.

• Update the Subject Status rule action to specify an Event Group, Event, or Form.

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

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

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

This Item is configured to hide/show inside of an editable grid. Due to this, Vault will display this Item as enable/disable.

• Update the Display Type to Enable.

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.

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.

Two or more Events have the same Label in the casebook. This may cause an issue when generating blank PDFs or in how the casebook displays to users.

• Update the Label of at least one Event so that the labels are unique.

Two or more Event Groups have the same Label in the casebook. This may cause an issue when generating blank PDFs.

• Update the Label of at least one Event Group so that the labels are unique.

The Length for the Item associated to the Codelist is longer than the longest Code value in the Codelist.

• Update the item’s Length to match the lenth of the longest codelist Code.

There is a Form Definition mapped to the E2B section, but the section is missing the respective E2B ID to Item mappings.

• Add Item mappings to the E2B section

• Remove the Form Definition mapping from the E2B section

There is a Form Definition mapped to the Study Drug E2B section, but there are no E2B ID to Item mappings for that Form.

• Add Item mappings to the Form in the Study Drug section

• Remove the Form Definition mapping to the Study Drug E2B section