The following applications may have different release dates: RegulatoryOne, Safety, and Veeva Claims.
| Description |
Issue No. |
|
In cases where there are over 500 classifications that exceed the minimum number of documents per classification, TMF bot training jobs will fail.
|
DEV-606111 |
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In some cases, users receive an error message when attempting to test a Study Metadata Extraction model.
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DEV-592373 |
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When an override EDL template applies to a Study, Vault does not properly create new milestone items for EDL items if a milestone item for that EDL item already exists.
|
DEV-591907* |
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In some cases, Vault fails to update the Milestone Document when users change the EDL Item classification that the Milestone references.
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DEV-608460* |
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In some cases, users without certain view permissions/security profiles receive a server error when creating a Study Person record, though the creation of the Study Person record is successful.
|
DEV-605954* |
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In some cases, the Rename Connection action is erroneously available on the Connection (`connection__sys`) object.
|
DEV-594971* |
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Vault fails to properly recalculate the ESL when all Subjects are removed from a date-based Study and users initiate the Recalculate Enrollment Metrics action.
|
DEV-485669* |
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In some cases, when attempting to insert Metrics Over Time records via API, users encounter an "Operation Failed" error message and the records are not inserted.
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DEV-586583 |
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When users attempt to complete a Trip Report with unresolved Review Comments, Vault displays an error message without any details about the error.
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DEV-604364* |
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When users attempt to Generate Risk Assessment for a Study using an existing Study as the source, Vault displays an error and does not copy the Study risks.
|
DEV-613793* |
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In certain cases, Vault fails to correctly generate Payable Items for a Study with a Fee Schedule Template applied.
|
DEV-593106* |
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Users may receive an error when trying to add Document Types to Site Packages.
|
DEV-606178 |
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In cases where there is no user action configured on a study's country-level lifecycle, the study site lifecycle user action will fail.
|
DEV-607955 |
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When running Document Reconciliation for a Sites monitoring event, it may delete all related Site Document Check records.
|
DEV-592217 |
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Users may receive a server error on the TMF Homepage after an envelope task is added to the My Tasks page.
|
DEV-610607 |
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In certain cases, when you archive a document in your Source Vault, it is not properly moved to the archived state in the Source Vault when it is transferred to the Source Vault.
|
DEV-585922* |
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In certain cases, an unexpected error during agreement message processing for TMF transfer can result in duplicate documents.
|
DEV-602647* |
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Users may encounter a CDX issue when attempting to transfer a placeholder document with a simple ruleset.
|
DEV-594619* |
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In some cases, when users attempt to download ePro report files, Vault does not download the ZIP file and instead displays a text file in the browser window.
|
DEV-592667* |
| Description |
Issue No. |
|
Users are unable to access Link to Content mode directly from View mode on a document in the Library.
|
DEV-607455* |
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Vault may fail to regenerate a document's name after document type reclassification.
|
DEV-610078 |
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Following bulk deletion of documents, Vault does not update the total count of documents in the Cart.
|
DEV-502500* |
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The navigation arrows within the Document Inbox may disappear once the document has reached a steady state.
|
DEV-582734 |
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Users may experience a rendering delay when migrating large batches of customs renditions.
|
DEV-602603 |
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Vault is unable to render documents with a .xlsx file extension.
|
DEV-612125* |
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PDF/A conversion fails if a document contains multiple fonts with the same names and subtypes.
|
DEV-599882* |
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In some cases, Vault fails to render PDF source files with PDF/A-1b selected in the File Rendition Settings.
|
DEV-589612 |
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In some cases, Vault fails to update the File Created By and File Last Modified By fields in the Document Properties on uploaded PDFs with the user’s current date and timezone.
|
DEV-592464 |
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When the Rendition Profile is set to Generate compliant Viewable Rendition for Source PDFs, any bookmarks in the PDF disappear after the re-rendering process. The Navigation Tab field in the PDF’s properties will still show Bookmarks Panel and Page despite the missing bookmarks
|
DEV-590862 |
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When a document with link annotations is re-rendered with the Preserve Annotations setting enabled, the annotation remains visible but the link becomes missing.
|
DEV-574422* |
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The Edit Bookmarks button is available on unlocked Protected PDFs.
|
DEV-592679* |
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f a user re-renders an encrypted PDF, the I want a rendition in PDF/A format option is available for selection in the Re-render Document dialog.
|
DEV-559831* |
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If a secured PDF is re-rendered in PDF/A format, any security on the document is removed.
|
DEV-558124 |
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Under certain circumstances, Vault fails to render large Excel files.
|
DEV-595836 |
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In some cases, users encounter an unexpected error when downloading Formatted Output documents.
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DEV-578834 |
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If a currency formula field on an object record is set to use Local Currency, and the object record is downloaded as a formatted output, the resulting document displays the Corporate Currency instead of the Local Currency.
|
DEV-591916 |
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The Title field in the Doc Info panel does not update to the latest title when a merged document is used as the source with an event action.
|
DEV-587162* |
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In some instances, generating a viewable rendition from a workflow causes a timeout with the error message: "Rendition generation is taking a while. Please refresh your page or try again later" or "Vault is unable to render this file".
|
DEV-602589 |
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Merge Field tokens fail to merge if the token includes a special character, such as /, @, [, ], and #.
|
DEV-596823 |
|
If a Rendition Status log with over 65,536 rows of data is exported to CSV, the resulting file will truncate the rows down to 65,536.
|
DEV-555301 |
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When Vault renders a document with table of contents titles longer than one line, text wrapping on the titles is lost in the viewable rendition.
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DEV-595615 |
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When Vault renders a document with the Blue Link option selected, the sub-headings in the viewable rendition’s table of contents do not render as blue.
|
DEV-605629 |
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Vault Owners receive a permissions error when attempting to download a Large Size Asset Rendition that is over 4GB.
|
DEV-594832 |
| Description |
Issue No. |
|
In some cases, users experience a server error when opening an object record audit trail.
|
DEV-608130* |
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When editing a record from the More Actions menu in list view, the fields on the record may have incorrect values when compared with editing a record from the record details page.
|
DEV-581198 |
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When checking the syntax of a formula expression for a formula mask, Vault may not display accurate number padding.
|
DEV-590544* |
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Admins may encounter two error messages instead of one when checking the syntax of an invalid validation expression.
|
DEV-607685* |
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When entering a formula field on objects, formulas that reference another formula field pass the "Syntax Check" button but error when clicking the "Save" button.
|
DEV-598565* |
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When entering a formula field on objects, if you've navigated to that formula field from a parent field, the formula passes the "Syntax Check" button but errors when clicking the "Save" button.
|
DEV-589989* |
|
Under certain conditions, Vault throws a server error when trying to save a field default value that includes a space character.
|
DEV-592788* |
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The "Allow create new reference record" setting may be incorrectly enabled for document reference fields on objects.
|
DEV-593467 |
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Users encounter an error when attempting to enable the previously disabled "Values must be unique" setting on a simple join object field.
|
DEV-596584 |
|
Using the navigation page to view related records may result in a page not found error.
|
DEV-600026 |
| Description |
Issue No. |
|
In some cases in Vault LIMS, the system may display a server error when the Generate Lab Tests action executes as a user or event action.
|
DEV-591636* |
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In Vault LIMS, when a user attempts to hierarchical copy a test definition record, the copy may not contain child records as expected.
|
DEV-590345* |
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In some cases in Vault LIMS, the system may display an error when a user attempts to create a new version of a sample plan or specification record.
|
DEV-591244* |
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In Vault LIMS test execution, the Actual amount field may be incorrectly required for Consumable inputs which don't specify an amount.
|
DEV-609720 |
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In some cases in Vault QMS, scrolling within the Risk Builder interface may cause the interface to shift up and down unexpectedly.
|
DEV-594302* |
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Vault may display an incomplete error message when the Activate External Collaborators action executes and detects a duplicate external username.
|
DEV-594107* |
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Vault may display an error when attempting to execute the Activate External Collaborators document lifecycle entry action when the Quality External User Template includes certain token combinations including the ${PersonEmailPrefix} token.
|
DEV-594566* |
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Vault may display an error while transferring data from a Clinical Operations Vault to a Study Training Vault if an object reference field rule is inactive.
|
DEV-579343* |
|
In some cases, the Study Training to Clinical Operations Vault Connection job transfers object records which do not fulfill the conditions for transfer.
|
DEV-590630* |
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In Validation Management, when a user navigates to a requirement record detail page from the Requirements Burndown View, Vault may not display a navigation breadcrumb in the top left of the detail page.
|
DEV-594833* |
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In some cases in Training, Vault may display an error when a user attempts to click the Filter icon on the Learner homepage.
|
DEV-614904* |
| Description |
Issue No. |
|
When users drag and drop Active Dossier records into the viewer and do not populate the Product field with the Inactive Ingredient field, Vault does not display the created records in the viewer.
|
DEV-544331* |
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When an Active Dossier Item Detail record references a common country (EU, GCC), users attempting to clear the Active Dossier Status receive an error.
|
DEV-600775 |
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Hovercards in the Active Dossier Viewer display an error for Common (GCC) Active Dossier Item Detail records.
|
DEV-602299* |
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The Active Dossier Viewer does not display the submitted icon and hovercard for Common (EU) Active Dossier Item Detail records.
|
DEV-602304* |
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Vault does not update the Published by Vault field when publishing a reference leaf via continuous publishing.
|
DEV-589751* |
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Users cannot lock a Content Plan (perform a hierarchical state change) when the plan contains a Content Plan Item without a published document and its XML Operation field set to “Delete”.
|
DEV-589325 |
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When a matched source document includes Vault annotations to permalinks to multiple targets, on-demand publishing does not up-version source documents and resolve the link if a target document is updated.
|
DEV-552009* |
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Permalinks to named destinations within a target document published as a viewable rendition resolve to the first page of the document rather than the named destination.
|
DEV-577927* |
|
Vault link annotations to multiple lines of target document resolve incorrectly during publishing.
|
DEV-594956 |
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During continuous publishing triggered by updating the Source for Published Document or Published Output Location, Vault up-versions matched documents which are not Ready for Publishing.
|
DEV-598716 |
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When a user sets a reference leaf and clicks Save, they must refresh the page in order to view the updated Published Output Location and Node Type.
|
DEV-605064* |
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When a Submission has multiple Clinical Study or Nonclinical Study relationship records, the Set Leaf Operation dialog does not auto-expand to the section containing both records.
|
DEV-592800* |
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When setting a leaf operation for multiple Submissions, users must apply filters for a specific Submission in order to view STF XML files in the dialog.
|
DEV-603493* |
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Depending on a user’s browser zoom level, longer leaf and section titles overlap and are not readable within the Set Reference Leaf dialog.
|
DEV-603244 |
|
Vault incorrectly reports GCC Rule 12.9 as passed when a Labeling or Cover Letter Content Plan Item contains an incorrect xlink:href value.
|
DEV-613762* |
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Vault incorrectly reports US Rule 1085 as passed when an Content Plan Item's full source file path is greater than 230 characters.
|
DEV-598738* |
|
Vault executes (instead of skips) validation checks of FDA Forms against US Rules 5005, 5020, and 5040.
|
DEV-605047 |
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Vault incorrectly reports US Rule 1255 as failed for ANDA submissions when items in sections M1-14 and M1-16 are Microsoft Word documents, reflected in the Published Output Location as .doc.
|
DEV-613765 |
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In some cases, when a Content Plan Item’s XML Operation is set to Delete, the item is not updated accordingly in the Submissions Archive Viewer during publishing.
|
DEV-602154 |
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When managing registered details, the Summary page “Finish” button is disabled when the request exceeds the number of records allowed for creation or update.
|
DEV-595772* |
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When a user splitting Activities navigates back from the Summary page to the Define Relationships page and de-selects a record, Vault directs them to a blank Define Relationships page instead of the Summary page.
|
DEV-608164* |
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Users without Read permission for the Application object are able to view but not execute the Create Registrations action.
|
DEV-610772* |
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When a user clicks the Apply button in the Managing Registered Details wizard, the lifecycle state is not applied for the Registration.
|
DEV-593089* |
|
Vault may fail to populate Acknowledgements on the Product Data Message for Investigational Medicinal Products.
|
DEV-601805 |
|
In some cases, filtering for Matched Documents within the Content Plan Viewer may return incomplete data.
|
DEV-593171 |
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When a user expands a content plan section at the bottom of the tree within the Active Dossier and Content Plan viewers, the view jumps back to the first expanded section in the tree.
|
DEV-598627* |
|
In some cases, the Create from Document user action fails to generate a matched document for the related Report-type Content Plan Item.
|
DEV-602341 |
|
When copying into a Content Plan, the success and failure counts in the resulting notification do not include the total number of matched documents.
|
DEV-596193* |
|
The Copied From field value is not set on inactive Content Plan records created from the Dispatch/Copy and From/Into Content Plan Actions.
|
DEV-580578* |
|
Leaf source file path correction is incorrectly skipped on submissions missing a value on the dossier status field.
|
DEV-609283 |
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In some cases, users may see an empty section warning in the Submissions Archive Viewer when it does not apply.
|
DEV-601177 |
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When a user without Read permission for the Submission Metadata object selects Where Used in Archive, the Submissions Archive Viewer does not load. For users with Read permission, the viewer loads but does not automatically expand to the selected location.
|
DEV-601968* |
|
For China (CN) eCTD submission records, there are typographical errors in the labels of sections 1.4, 1.4.6, and 1.8.1.
|
DEV-606182 |
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Vault does not apply overlays to viewable renditions downloaded from the Submissions Archive Viewer.
|
DEV-604498 |
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Users without Read permission on the Submission object and object types are able to view them in the Submissions Archive Viewer.
|
DEV-602110* |
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In some cases, when a user attempts to access the Viewer tab, it appears blank.
|
DEV-603271 |
|
Under certain circumstances, users receive a Page Not Found error when accessing the Viewer tab.
|
DEV-608234 |
|
Admins may encounter a deployment failure when migrating Impact Assessment Report records.
|
DEV-595936 |
|
RIM submissions encounter an error where the output generates a PDF all pages are missing after the first page. The second page includes an error: ERROR: syntaxerror OFFENDING COMMAND: –nostringval–.
|
DEV-589023 |
| Description |
Issue No. |
|
The audit trail on inbox items created from E2B files displays picklist names instead of labels.
|
SAF-42631* |
|
For unblinded Cases, changing the Study Report Type to a custom value breaks the blind on Product Names.
|
SAF-42695* |
|
Users with the Case Processing security profile are unable to view data in the Medical Review Timeline of an inbox item that has been promoted to a Case.
|
SAF-42713* |
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When Study Cases have postmarketing PMDA Reporting Categories, Localized Study Names are not exported to the C.5.2 Study Name data element on PMDA E2B(R3) reports.
|
SAF-43653 |
|
In some instances, the system times out when running Multi-Pass Reports for Non-Vault Owners.
|
SAF-44044 |
|
Reporting Rules are not evaluated correctly for Reporting Families with Product Registrations.
|
SAF-44332 |
|
In some instances, a server error occurs when Non-Vault Owner users try to view the Medical Review Timeline section of Cases.
|
SAF-44404 |
|
The system automatically voids Cases when they have no Primary Products or the "Generate Assessments for both Serious and Non-Serious Adverse Events" setting is turned off.
|
SAF-44406* |
|
In some instances, WHODrug-coded Substance Names for External Products are missing parentheses, leading to incorrect population in the B.4.k.2.2 Substance / Specified Substance Name data element of E2B(R2) reports.
|
SAF-44531 |
|
When a PMDA Case has multiple LRDs, the values entered in some J2 fields and Localized Case Comments are mapped from the wrong LRD upon export.
|
SAF-44906 |
|
Warnings don't appear when the Case Product Dosage Frequency field is missing either a unit or number value.
|
SAF-45081* |
|
When generating E2B files, Dose Forms from the Controlled Vocabulary are not truncated to 50 characters.
|
SAF-45515 |
|
When the Generate Assessments user action completes, system notifications do not appear.
|
SAF-45796* |
|
The system automatically voids Cases when there are no Primary Products or Assessments in their source E2B files, and the resulting error message does not reflect the real issue.
|
SAF-46260 |
|
The Due Date field on Localized Cases is not set to the earliest due date from their Localized Case Assessments.
|
SAF-46301* |