Release Date: August 2 & August 9, 2019


The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future Vault releases.

Last Updated: August 2, 2019

Admin

Description Issue No.
In rare cases, users cannot delete sandbox vaults.   DEV-260525
When using the legacy Users functionality (rather than User object) to add an existing user to another vault, the user’s profile image does not populate in the second vault.   DEV-262223
When creating a sandbox vault, a document synchronization in progress error may display if undergoing source content migration is underway for the parent vault.   DEV-262083
When uploading a CSV file using Vault Loader, if the job fails, Vault does not report the correct number failures.   DEV-263379
In some vaults, LatestVersionDoc is a Number field while in others it is a Yes/No (boolean) field. It should always be Yes/No.   DEV-248064
Some users are experiencing server errors when using Vault Loader.   DEV-243944
Some users are unable to delete sandbox vaults.   DEV-260525

Commercial

Description Issue No.
When using Brand Portal, Vault does not add documents to the Recently Added widget.   DEV-263837

Clinical Operations

Description Issue No.
The binoculars icon may not work correctly when editing a Monitored Informed Consent Form if the Site Informed Consent field uses Criteria VQL.   DEV-263060
In rare cases, Vault encounters a “Server having problems” error when attempting to save documents.   DEV-261673
On the Study Startup page, the “Back to” link may not function properly and return a “Page Not Found” error.   DEV-261733
When sorting tasks requiring attention by due date, Vault displays records in reverse order. For example, if a user sorts records in descending order, Vault displays records in ascending order.   DEV-259762
When recalculating metrics over time, Vault does not correctly update Actual values after updating the Subject Enrolled date.   DEV-254053

Developer Features: API

Description Issue No.
When adding a user that exists in another vault via API, Vault may describe an incorrect error in the failure email message.   DEV-260965
When attempting to update a group with an invalid user ID, Vault returns FAILURE rather than EXCEPTION.   DEV-260166
API will return an HTML-formatted error when two Authorization HTTP Request headers are erroneously included on the request. Users are encouraged to pass a single Authorization HTTP Request header only.   DEV-261854

Developer Features: MDL

</tr> </table>

Developer Features: SDK

Description Issue No.
Through MDL, users are able to configure an invalid record action by referencing different objects for the record and the action.   DEV-253236
When using MDL to create a component type with more than 61 non-blank characters in DEV-240882
Description Issue No.
A Spark Messaging Integration rule with a Picklist reference lookup type may result in an error.   DEV-260217
Users cannot create a Vault to Vault connection between a Limited Release vault and a General Release vault when the vaults are on different release versions.   DEV-259351
Users cannot create a Vault to Vault connection between a Limited Release vault and a General Release vault when the vaults are on different release versions.   DEV-259351
Vault displays a server error when a user completes a task if SDK code attempts to cancel the current task being completed.   DEV-257942
Vault displays a server error if you deploy SDK code creating the only read-only participant without workflow participant permissions.   DEV-256354
Vault displays “Server having problems” message when a user with only Queue Log permission or no Queue permissions at all tries to create a trigger object for a QueueService record trigger.   DEV-251484
When a user has read-only, edit, or delete but no create permissions for queues, QueueService allows them to create messages for queues even though they should be restricted.   DEV-251477
When a new RecordAction is deployed through the auto-provisioning upgrade task, the RecordAction can be referenced by objects but sometimes does not appear in the Actions menu.   DEV-250976
The SDK debugger does not apply current user permissions to entrypoints being debugged.   DEV-249589

Developer Features: VQL

Description Issue No.
When queried from VQL, values for modified__date__v are inconsistent with the same values in the database.   DEV-255433
When queried from VQL, values for modified__date__v and created__date__v are inconsistent with the same values in the database.   DEV-255433
Some users are experiencing unexpected errors when querying for the name__v field of related objects.   DEV-248668

Documents

Description Issue No.
Vault intermittently fails to re-render images with OCR-readable text.   DEV-256431
Disabled document fields with a value may not be searchable.   DEV-252078
If all Multichannel features are disabled, Vault does not save values for Subject (subject__v) and CRM Territory (territory__v) when a user populates them during document creation or document edit.   DEV-250079
UI edit and delete functionality may be inconsistent when using MDL to create a standard (__v) Savedview.   DEV-247165
Vault occasionally fails to save automated image renditions after generating them.   DEV-246623
The Target Document field is not required when creating Link Target object records.   DEV-245385
Under certain conditions, a document search may return an incorrect version unless sorted by descending order.   DEV-240977
In rare cases, Vault cannot generate viewable renditions if a document contains unresolved merge fields.   DEV-259218

Lifecycle & Workflow

Description Issue No.
Vault erroneously allows deletion of document types, subtypes, and classifications referenced by Document Lifecycle Event Action, Conditional Overlay, and eSignature conditions.   DEV-253972
In certain configurations, the Update Document Sharing Settings step on multi-document workflows allows Vault to assign users who are not allowed to a participant role.   DEV-250825
In some cases, Vault Loader jobs fail if one or more records do not meet SDK event action conditions.   DEV-250270
Vault is experiencing performance issues when updating document fields as part of a Multi-Document Workflow.   DEV-245205
In some situations where two tasks complete simultaneously for an object workflow, the workflow gets stuck and does not complete.   DEV-238733

Localization

Description Issue No.
Collapsed sections on the object details page do not show translated labels. This can cause non-English users to see English labels in a Vault.   DEV-261487

Objects

Description Issue No.
In some cases, Vault allows users to create a layout rule referencing a deleted component.   DEV-256167
When a validation rule is configured on a field that is not included in an object record detail page, and validation fails, the validation error message displays incorrectly.   DEV-253174
When creating a new object reference field, Vault shows “documents” when selecting the Document option. This also happens for vaults that use non-English languages.   DEV-262094

Performance & UI

Description Issue No.
Some fields are not populated correctly in Create Related Record popup dialogues.   DEV-263056
In some cases, layout rules cause the value of a Record Select field to display and save incorrectly   DEV-261904
Vault sometimes displays a blank page after a user selects a value from a picklist that is compared with another picklist field as part of a layout rule.   DEV-261440
Waiting for clarification.   DEV-260610
Under certain conditions, editing the date field in an AER may not work properly.   DEV-258065
Under certain conditions, a blank page may display after selecting a value from the Age Onset Picklist when creating an AER.   DEV-256871
Adding a field to a page layout silently leaves the page in edit mode when the added filed is not enabled for the object type.   DEV-256870
The hovercard may persist after mouseover for an AER created from a document.   DEV-255804
Under certain conditions, the user is not notified if a required property type is missing.   DEV-255608
A blank page may appear if an application control and object filed are on the same page layout.   DEV-255332
When a user updates a date-time field on a record, Vault resets the second’s value to :00.   DEV-246436
Users on a Microsoft Edge browser cannot always click on bar charts across various Vault applications.   DEV-261777

Quality: Station Manager

Description Issue No.
In certain situations where the Android OS is trying to save resources, document syncing can fail if Station Manager is running in the background on a device.   VMI-3320

QualityOne

Description Issue No.
The error log contains insufficient details to help users troubleshoot the causes of failed Update Training Assignments jobs.   DEV-265072
After adding the Training Management application to Vault, the Learner User license type may be missing from the License Type drop-down when creating a user.   DEV-261761
Vault returns an unclear error message after users upload a Checklist Design Loader CSV file containing more question design records than the maximum allowable number of records per section.   DEV-254760

Regulatory

Description Issue No.
In some cases, users see a server error when attempting to expand Module 4 in the Submissions Archive Viewer.   DEV-262054
The publishing job fails for large Report Level Content Plans that contain more than 1,000 documents with over 5,000 links.   DEV-260082
In the Gateway Submission dialog, Vault doesn’t use the Submission Format field’s label in the error message if that field is blank on the Submission.   DEV-260046
In some cases, submission import fails when importing submissions via the FTP.   DEV-257569
Vault sometimes does not render XML documents from imported submissions.   DEV-255920
In some cases, users experience slower than usual performance when exporting large Content Plans.   DEV-261984
Some users are not receiving the INVALID_IMPORT_FORMAT response when importing empty submissions via API.   DEV-262089, DEV-253848
In some cases, Vault does not import folders as unreferenced even when “Import unreferenced files” is enabled.   DEV-259743
In some cases, Vault reports PDF rules after continuous validation jobs even if there is no matched document.   DEV-257929
In Vaults with in-line validation not enabled: When unmatching a document from an EDL item and running on-demand publishing, Vault may not correctly update the validation result.   DEV-257700
In some cases, Vault incorrectly reports valid bookmarks within an EDL submission as invalid.   DEV-257580
In some cases, Vault may fail to publish Report Level Content Plans with link annotations.   DEV-256862
Vault includes incorrect date and time information in the export notification when users bulk export submission dossiers in Submissions Archive.   DEV-256736
Vault does not set all Publishing Validation Result records to Inactive when an Inactive Content Plan Item within a report level content plan has an existing Publishing Validation Result record and the Inline Validation Results feature is enabled.   DEV-256336
After publishing a submission, Vault reports incorrect values under the Detailed Publishing Results for Rule 1204.   DEV-256317
The Viewer tab is slow to load applications with a high number (over 1,000) submissions.   DEV-255545
Validation Rule 9.7 for EU submissions does not report any failures if the Application UUID field is blank on the Application record.   DEV-255385
In some cases, when users match a document containing a link target to a Content Plan Item and the continuous validation job runs, Vault reports duplicate validation errors for PDF bookmark and hyperlink rules.   DEV-255330
In some cases, Vault returns inconsistent validation results for PDF documents when users run on-demand validation   DEV-254782
Vault does not verify that the publishing job is complete for non-primary submission documents when the Publishing Complete entry criteria is configured and a user changes the state of a grouped submission.   DEV-252879
When users select the Upload action from a Content Plan Item record but do not classify the document, Vault creates the unclassified document but fails to match the document to the Content Plan Item.   DEV-252712
Some labels for user actions in Regulatory vaults display in English after a user selects a non-English language in their User Profile.   DEV-252536
When there are several validation errors for a Content Plan Item with a matched PDF document, Vault erroneously populates the “Source (Matched) document URL” and the “Published Source (Matched) document URL” with the link to the PDF for non-PDF validation rules.   DEV-251996
Vault erroneously executes Rule 2002 for all Content Plan Items in a submission instead of only XML Content Plan Items.   DEV-250785
Vault should not report a validation error when the XML Title is blank for a submission’s index node.   DEV-250093
When a user deletes a Content Plan record that is part of a published submission, Vault should remove all child Content Plan Items and their associated CSV files from the Submission record.   DEV-242966
Vault erroneously reports Rule 15.8 when a Content Plan exists for a submission join record.   DEV-241230
In some cases, when users filter to a Submission in the Submissions Archive Viewer, navigate to a document, and then click the Back to Viewer link, Vault removes the filter and collapses the Tree View.   DEV-240480
When multiple Content Plan records have the same XML Element Name, some leaves don’t display correctly in the Submissions Archive Viewer after the continuous publishing job runs.   DEV-238911
In rare cases, Correspondence documents appear under the wrong submission if the submission import is in the ERROR state after being canceled.   DEV-263628
In some cases, Vault throws a server error after marking a record in a Content Plan as a favorite in the hierarchy viewer.   DEV-263582
The binoculars icon does not open advanced search when searching in the Submission Type field.   DEV-263545

Reporting

Description Issue No.
In some cases, Vault encounters a server error when attempting to run a Multi-Pass report that joins two objects with Created By filters.   DEV-261842
In some cases, blank values are included before actual values in reports.   DEV-261142
In some cases, users are unable to run reports that are configured to filter on object formula fields.   DEV-260647
Vault displays a server error when running Multi-Pass Distribution and Distribution with Documents reports.   DEV-254027
Vault may display a server error when running a report with the Document > Source Link column included.   DEV-252240
In certain reports, clicking into a record and then “Back to report” results in Vault clearing a report filter.   DEV-251121
In a Multi-Pass Report that filters on a field value with field-level security (hidden), Vault does not apply the filter correctly and shows values that should be hidden for the report user.   DEV-242701
For dashboard components that use a second grouping field, if that field is a date field, Vault sorts the categories alphabetically.   DEV-237783
Using MDL, users can join two views (Multi-Pass Report) with different data types.   DEV-237736

Safety

The Safety release, including all Platform known issues, is targeted for tentative availability on August 9, 2019.
Description Issue No.
When you start uploading a MedDRA dictionary from Business Admin > Dictionaries > MedDRA Dictionary, you cannot view MedDRA records on the Business Admin > MedDRA page until the system finishes uploading the dictionary. While the upload is in progress, the MedDRA page displays a “Page Not Found” error. The system sends an email notification when it completes the upload action.   SAF-148
During E2B import, if the file contains a value that results in a data-type mismatch with the corresponding Vault Safety picklist or codelist field, the import operation fails. This issue does not affect text fields. For example, if the E.i.6a: Duration of Reaction (unit) section contains a string value that does not map to the options in the Vault Safety Duration (unit) field, the import fails. When this issue occurs, an error similar to the following appears:
We could not complete “Extract E2B” for the following reasons: NumberFormatException [SDK_ERROR:Mapping e_i_6a_durationNumber]]
 
SAF-162
Vault Safety currently supports only English language versions of the MedDRA dictionary. When you try to upload a non-English dictionary, the upload operation fails. Vault Safety will provide multi-language support for the MedDRA dictionary in a future release.   SAF-166
On a Case source literature document, you should not be able to select a value in the Reference (reason omitted) field when you enter a value in the Reference field. However, the system currently allows you to enter values in both fields.   SAF-466
When you import an Adverse Event Report E2B file with multiple case diagnoses, the system may not import any diagnosis information. This issue occurs when multiple diagnosis MedDRA codes are separated by any character that is not a comma, such as a semi-colon (;) or other special character.
Workaround: If you experience this issue, perform one of the following workarounds:
  • Edit the E2B file to separate each MedDRA code using only a comma, and then re-import the Adverse Event Report.
  • Manually create each Case Diagnosis record on the Case in Vault Safety.
 
SAF-760
If you turn on blind protection on a Study Product record, you may see unexpected results. The Case or Study blind protection settings override the Product settings. For example, if you turn on blind protection on a Study Product under a Case with blind protection turned off, the Product is not blinded. We recommend that you only configure blind protection at the Case or Study level.   SAF-987
The WHODrug Search browser may not return results for incomplete product names. The browser searches for product names that match the exact spelling of the search input. You can search incomplete product names only when you enter the letters the name starts with. For example, if you are looking for the product Cholecap and search for lecap with the Drug Name column selected, the search returns no results. However, if you search chole, the search returns results for Cholecap. Make sure to use the correct spelling for search terms. If you must search a partial name, always search using the start of the product name.   SAF-1045
If you edit a Case field to turn on User must always enter a value (required), when you import an E2B file that does not contain a value for that field, the import operation fails without a clear failure notification.Do not change the User must always enter a value (required) option on standard Object Type Fields under the Case object if you are importing E2B files.   SAF-1057
When an E2B import action fails with multiple issues, the log file contains only the first error that the operation encountered. After encountering an issue, the system stops processing the file.   SAF-1062
When you import an Adverse Event Report E2B file with both a valid MedDRA code and MedDRA free text, the system does not map the MedDRA code to the Name (MedDRA) field. Instead, the system maps both the MedDRA code and the free text to the Name(Reported) field.   SAF-1142
When you import an E2B(R2) file with lab test results, the system may not correctly map the result unit and qualifier. Instead of populating the qualifier and test result code, the system may map the result, result unit, and qualifier information to a combined free text description in the Result (Text) field. The following known limitations cause this behaviour:
  • The system cannot interpret qualifier symbols (<, <=, >, >=) within the testresult tag
  • The system cannot interpret numeric code values in the testresult tag

If you import an E2B(R2) file with lab test results, verify that the Case contains the correct records under Lab Test Results and, if required, manually map the information to the Result and Result (qualifier) fields.
 
SAF-1151
If you import an E2B(R2) file with an invalid MedDRA code in either of the following sections, the system does not import that section to the Vault Safety Case:
  • B.1.9.2.b Reported cause(s) of death
  • B.1.9.4b Autopsy-determined cause(s) of death
 
SAF-1155
After uploading a source Adverse Event Report file to the Library, you cannot use the file to create an Adverse Event Report while the system is loading the file rendition. If you select Create AER from Document from the menu while the system is loading the rendition, a message similar to the following appears:
Failed to update Document property of Document[6_0_1], with case ID[V2B000000000108].
Workaround: Wait until the system loads the rendition before you select Create AER from Document.
 
SAF-1175
When you export a Case with lab test results as an E2B(R2) file, the system exports the test result unit as text instead of the Unified Code for Units of Measure (UCUM) numeric code. For example, for a test result with a unit of kg, the system populates the E2B file with \<testunit\>kg\<\/testunit\> instead of using the UCUM code for kg, 001.   SAF-1184
When you import an E2B(R2) file, the system imports the \<\!\-\-B.4.k.17 reaction recurrence\-\-\> section only when the \<drugrecurreadministration\> tag contains either 1 or Yes-yes. If the tag contains any other value, the system does not import the section. The system notification about the E2B import does not display a warning about losing the recurrence data.   SAF-1208
During an E2B(R2) import the system imports only MedDRA Lower-Level Terms (LLT). If you specify the Preferred Term (PT) only, the system does not import the MedDRA value. However, if you specify both the LLT and PT for a data element, the system maps only the LLT.   SAF-1226
When you import an E2B file that maps to a Study configured in Vault Safety, the imported Case is missing study registration and product information that exists in the Study library but not in the E2B file. This issue impacts the following Case records:
  • Study Registration
  • Product Substance

Workaround: If you experience this issue, deselect and reselect the Study or Product.
 
SAF-1262
If a validation error occurs when you try to save an object, such as an Adverse Event Report or Aggregate Report, the system skips ahead to the next number in the series when assigning the name. For example, if you do not specify the receipt date on the first Adverse Event Report in Vault Safety and try to save, a validation error appears. When you correct the receipt date and save the page, instead of assigning the name AER-000001, the system assigns the name AER-000002.   SAF-1338
If you edit an Adverse Event Report to remove the value in the Date of Birth field and save the page, the value in the Age Group field is cleared.   SAF-1345
If a Case references a Product record that does not specify the product registration country, the following scenarios fail with a null pointer exception error:
  • When the system calculates the Case due date.
  • When the system creates the Case Submission record.

Ensure that you set the product registration country for Case Products.
 
SAF-1388
If a blinded Study Case references concomitant Drug or Biologic type Products, you cannot keep the blind when you complete the Unblinding task. This issue does not affect External-type Products. If you select Keep the Blind as the verdict in the Unblinding task window, an error similar to the following message appears:
An error occurred while performing the action: Field [blinded__v] is not valid for Object Type [biologic__v]
Workaround: If this issue occurs, contact your Veeva Services representative.
 
SAF-1856
When you generate an FDA 3500A report from a Follow-Up Case, the system populates the Follow-up# field as 2 instead of 1.   SAF-2219
When a Case links to a Study that does not match the Study that the Case Product is associated with, the Case becomes out-of-sync and the system does not allow follow-ups. When you try to create a Follow-Up Case on an out-of-sync Case associated with a Study, the system displays the following unclear error message:
An error occured while performing the action: [Input Position [0] Error [{type=’INVALID_DATA’, subtype=’null’, message=’Invalid value [SAF- 476_DoubleBlindNull] specified for parameter [study__v}’}]]
If you see this error message, ensure that the Study under the Case matches the Study associated with the Case Product.
 
missing issue number
Vault Safety does not import case assessments and assessment results from an E2B file when there have overlapping or incorrect references.   missing issue number
When you create a copy of a Case, the Case descendant records are not copied to the new Case. The system copies only the Details, Narrative, Patient, and System sections to the new Case. You must manually add all Case descendant records.   missing issue number
In the scenario where an adverse event occurred before or on the patient’s birth date, be aware of the following limitations.
Adverse Event Report Age Calculation
In a Vault Safety Adverse Event Report, if the date entered in either the Event Onset or Receipt Date field is on or before the date entered in the Date of Birth field, the system cannot calculate the patient’s age. When this scenario occurs, the system displays an error. To save the Adverse Event Report, you must manually enter the patient’s age at the onset of the adverse event in the Age field.
Case Age Calculation
In a Vault Safety Case, if you add an adverse event with an Onset date on or before the date entered in the Patient > Date of Birth field, the system updates the value in the Patient > Age field to 0. Manually enter the patient’s age at the onset of the adverse event in the Age field.
 
missing issue number
When you generate a CIOMS I for a Case with a normalized Age at Onset value that is too long to fit in the CIOMS I Age field, the system populates age value in scientific notation. This issue occurs because the CIOMS I Age field is in years. When Vault Safety calculates an age with a partial year, the age becomes a decimal value that may not fit in the CIOMS I form. When the value does not fit in the form, the system generates the scientific notation equivalent. For example, if a patient’s Age at Onset is 12 hours, Vault Safety calculates the normalized age as 0.0014 years, which is populated as 1.4e3 in the CIOMS I Age field.   missing issue number
Vault Safety does not yet support the FDA 3500A Devices section. When you generate a FDA 3500A report, the system leaves the Devices section blank.   missing issue number
Currently, Vault Safety is limited in the number of suspect or interacting products that it can populate when generating a case report. In 19R1, Vault Safety supports exporting the following number of suspect or interacting products during report generation:
  • Only one suspect or interacting product for the CIOMS I report.
  • Only two suspect or interacting products for the FDA 3500A report.

If the number of suspect or interacting products exceeds the above limits, the additional product information is not populated on the report.
 
missing issue number
When you create custom object types on Veeva standard objects, you should not disable standard fields. If you disable standard fields on the custom object type, Vault Safety may not work as intended. You can identify standard objects and fields by the __v in the name.   missing issue number
When you disable page layout rules on a Case associated with a Study, you are able to set a non-study Product as Primary, which causes the system to clear all study-related information under the Case. If this issue occurs, set the non-study product Primary field to No and set the appropriate Study Product Primary field to Yes. Once you set a Study Product as Primary, the system restores all study information under the Case. If the Case has two or more Study Products and you try to change the Primary Product to a non-study Product, the system prevents you from saving the changes with an error message similar to the following:
We could not save “Case Product” for the following reasons: One or more Case Products dependent on this Study.
If page layout rules are enabled, the layout rules prevent this scenario from occurring.
 
missing issue number
If you configure a custom notification with a token for Vault Safety actions, the notification does not populate the token value. You cannot use Vault Safety-specific tokens in custom notifications. For custom messages, the system is limited to display only standard Vault tokens, such as Vault ID or domain. Vault Online Help website provides information on using standard Vault tokens.   missing issue number
You cannot import an E2B file to create a Follow-Up Case directly. E2B import is supported to create an initial Case only.
Workaround:
  1. Import an E2B file to create an Adverse Event Report.
  2. Create the Follow-Up Case.
  3. Manually copy over the Case updates in the imported Adverse Event Report to the Follow-Up Case.
 
missing issue number

Vault File Manager

Description Issue No.
Occasionally, Vault File Manager stops automatically opening documents as a user checks them out from Vault. Rebooting Vault File Manager corrects this issue.   DEV-260480
Vault File Manager may stop working when automatic checkout is enabled for larger files.   DEV-249272