The issues listed below are fixed in the 20R2 release.
| Description |
Issue No. |
|
When a user hovers over or clicks the Display Rules link in an Object Record page's Sharing Settings, Vault does not properly display values for Matching Sharing Rules.
|
DEV-308655 |
|
In some cases, updating a security profile label does not update the "Profile Name."
|
DEV-324684 |
|
Under certain conditions, a user can access a vault as an Application Owner by getting delegate access to the Application Owner user.
|
DEV-312399 |
|
The Microsoft Edge browser User Agent is incorrect in the Login Audit History log.
|
DEV-288707 |
|
When the principal user's vault is disabled or deleted, delegated users may still appear in the UI even after the delegation has been removed or the user has been inactivated.
|
DEV-320113 |
|
Users are unable to create a second Checklist Type on the same Target Object for object types.
|
DEV-324988 |
|
Users are unable to deploy configuration migration packages containing an object, object lifecycle, and object workflow without manually reordering components due to missing dependencies caused by Vault incorrectly ordering the components.
|
DEV-326984 |
|
When a Test Data type migration package contains a field that references the User object, and no value is entered for that field, Vault incorrectly populates the field with the value of the Test Data User field.
|
DEV-327775 |
|
VPK deployment is blocked when a target component's label contains a comma.
|
DEV-322593 |
|
If component comparison fails during the Review and Select Steps step of Configuration Migration Package deployment, Vault displays a server error instead of the correct error in the Comparison and Dependencies dialog.
|
DEV-331412 |
|
When a user imports a migration package with a custom Objecttype component and a Checklistype component that depends on the object's base type, the Checklistype step is blocked.
|
DEV-320362 |
|
In some cases, files larger than 4GB are not removed from the FTP staging server inbox after they have been transferred to Vault.
|
DEV-317443 |
|
Users may receive a server error when attempting to view EDC Jobs from Admin > Operations.
|
DEV-320197 |
|
Under certain conditions, disabling and then enabling the unique setting for a field may result in a server error.
|
DEV-286621 |
|
Users receive a server error when trying to save a Checklist Design record with an empty picklist matching field.
|
DEV-324304 |
|
In some cases, certain fields are not available as tab filters when editing tab configuration.
|
DEV-292117 |
|
For active connections between a general release and a limited release vault, changing the connection to Pending in the limited release vault returns a server error.
|
DEV-328497 |
|
If an external connection URL leads to a 404, the Vault UI shows "Exception occurred: Unable to connect/send data to url" rather than "Http Resp Code: 404".
|
DEV-310777 |
|
When an Admin selects an option from the Actions menu for a web action on the Admin > Configuration > Web Actions page, nothing happens.
|
DEV-334213 |
|
When creating a custom tab, the lower Save button is disabled and users can only access the upper Save button.
|
DEV-307349 |
|
Some users experience a failure when generating Vault Configuration Reports that include Document components.
|
DEV-314724 |
|
In some cases, groups may not correctly display in the Users & Groups tab of the Admin section.
|
DEV-325263 |
|
The value for "system_owned_user__sys" is null for existing users.
|
DEV-286742 |
|
User license limit error messages may inappropriately appear in a sandbox environment.
|
DEV-319933 |
|
When creating a new object field with the Text field type, Vault does not allow users to set the Maximum Length above 255, although the limit should be 1,500.
|
DEV-319715 |
|
When a user edits an Outbound Configuration Migration Package to include Vault Java SDK code, clicking Save results in an error.
|
DEV-313374 |
|
In some situations, loading a VPK that generates a placeholder for an object lifecycle removes role permissions assigned by default.
|
DEV-319977 |
|
Admins cannot delete a signature page referenced by a deleted lifecycle.
|
DEV-315009 |
|
Vault Compare shows differences between two vaults, but these differences are only in private keys, not meaningful differences.
|
DEV-307338 |
|
The package comparison report shows differences for workflows configured prior to 20R1.0, even when the workflows have not been modified.
|
DEV-317392 |
| Description |
Issue No. |
|
In certain ca Study field of a document in Draft state is unexpectedly updated upon updating it to a steady state when the related Study Person record is in Proposed state.
|
DEV-326982 |
|
In some cases, Vault shows an inbound Job Status of Errors Encountered after a Product Family has been successfully transferred between Vaults.
|
DEV-302804 |
|
In some lifecycle state entry action configurations, updating the Quality Issues field on a document can cause the Export File Name field to become blank.
|
DEV-303617 |
|
In some vaults, the Study Person object is missing the external_id__v field.
|
DEV-319568 |
|
In vaults using the Clinical to RIM Spark integration, rerunning a failed job fails without an explicit error message if there is a typo in the document type configuration.
|
DEV-308624 |
|
The Recalculate Enrollment Metrics user action does not delete Metrics Over Time records as expected.
|
DEV-311914 |
|
In some scenarios, milestone rollups do not correctly populate the finish date in the related milestone dependency records.
|
DEV-318919 |
|
Upserting object records sometimes fails with an "unexpected error."
|
DEV-324975 |
|
Users are able to configure circular milestone dependencies.
|
DEV-309621 |
|
When creating milestones from a Template Milestone Set, Vault is not creating Clinical User Tasks for all sites.
|
DEV-321455 |
|
If the Block Automatic Updates field is is blank on a Milestone record, planned and actual finish date values do not rollup into the next Milestone or Milestone Dependency records.
|
DEV-333121 |
|
Unable to set the standard Study Role (study_role_clin) picklist on the Study Person object to inactive.
|
DEV-302656 |
|
Under certain conditions, Vault allows the creation of duplicate Study Person records.
|
DEV-324961 |
|
In some scenarios, CRF Import is vulnerable to Cross-Site Scripting (XSS).
|
DEV-309255 |
|
The Bulk Loader job fails when the batch size exceeds 200 sites.
|
DEV-320163 |
|
Bulk document transfer for Clinical Network is experiencing some performance issues.
|
DEV-286770 |
|
The Recalculate Enrollment Metrics user action does not delete Metrics Over Time records as expected after changing milestone dates.
|
DEV-316889 |
|
Under certain conditions, classification is not maintained on transferred documents.
|
DEV-327465 |
|
Under certain conditions, users experience a server error when executing the Send Agreement Invitation user action.
|
DEV-330052 |
|
Users without the Read permission for Queues are unable to save files after upload.
|
DEV-321350 |
|
Saving a Rule Set Document Where Clause Override record results in an error and the record is not created.
|
DEV-328451 |
|
Vault does not send Agreeements that are linked to Rule Override Owner types of rule overrides
|
DEV-328446 |
|
Vault allows multiple adhoc asynchronous jobs to run concurrently, creating duplicate EDL Items for milestones.
|
DEV-313970 |
|
When updating a Subject record linked to an archived study, Vault shows a server error (inline edit), sets the Study value to NULL (detail page edit), or shows an UNEXPECTED ERROR (API update).
|
DEV-311016 |
|
In some configurations, completing an eSignature task for a Monitoring Event results in an error.
|
DEV-335177 |
|
The "Back to Monitoring Events" breadcrumb takes users back to the record creation page, instead of the Monitoring Event record.
|
DEV-320302 |
|
In certain situations in CTMS when a Study is using Arm-Based Metrics, milestone jobs fail to complete due to a server error.
|
DEV-307054 |
|
Remarks may be out of order in a newly created CTN document.
|
DEV-312027 |
|
The Study Country field may not populate in a newly created CTN document.
|
DEV-311726 |
|
Executing the Create Subsequent CTN user action copies the Submission Date / 当該治験計画届出年月日(ctn_submission_date_v) field rather than the Submission Date / 届出年月日(submission_date_v) field to the new CTN record.
|
DEV-330621 |
|
Under certain conditions, some Vault messages may not appear properly.
|
DEV-312011 |
|
Automatch with a large number of placeholders causes performance issues.
|
DEV-314313 |
|
If "Enable automatic placeholders on new file upload" is active, users uploading new documents may be asked to identify placeholders even though a predefined placeholder exists.
|
DEV-314338 |
|
Under certain conditions, some Vault notifications are not displayed on the Home page.
|
DEV-315108 |
|
Vault removes all Product and Study values from original documents after snapshot versions have been archived.
|
DEV-328977 |
|
When Vault blocks study archive, the downloadable CSV does not include important information: Checked out Document ID or Milestone ID.
|
DEV-302857 |
|
Vault does not create new documents that include a document field that is configured as read-only and has a pre-save default value when the Enable Dynamic Document UI Defaulting feature is enabled.
|
DEV-334046 |
|
The Product field is blank on copied documents if the field is read-only.
|
DEV-334803 |
|
The Clinical to RIM Connection does not support field rules that contain a blank Query Field field and a populated Field Default field.
|
DEV-325609 |
| Description |
Issue No. |
|
In some scenarios, users cannot delete groups with and receive an error message stating the group is in use in document sharing settings, even though the group does not appear in any document sharing settings.
|
DEV-316855 |
|
In some cases, users see a server error when attempting to update a document that has an invalid Currency/Cost combination.
|
DEV-316030 |
|
Audit-trail export failures during a Binder Bulk Export or Document Bulk Export may result in an unexpected error.
|
DEV-301148 |
|
When viewing a document in the mini browser window, the note position and filter options are not functional.
|
DEV-308487 |
|
Vault doesn't include resolved annotations in filter counts, including the Resolved filter
|
DEV-339050 |
|
Vault doesn't include resolved annotations in filter counts, including the Resolved filter.
|
DEV-339050 |
|
In some cases, when a user exports highlight annotations, only the last character is highlighted.
|
DEV-324115 |
|
Vault sometimes places annotations incorrectly when importing offline annotations.
|
DEV-320292 |
|
When running an Import Annotations action, the process continued running without showing that it completed. After refreshing the document, users found that Vault had imported the annotations multiple times.
|
DEV-310722 |
|
Vault applies incorrect highlighting when a user views a document in comparison mode.
|
DEV-323208 |
|
When comparing certain documents, users are seeing more changes reported than expected.
|
DEV-306950 |
|
When comparing certain documents, users are seeing more changes reported than expected.
|
DEV-306950, DEV-312338 |
|
Vault attaches Large Size Asset rendition files to staged documents rather than the intended documents when users upload via FTP Inbox.
|
DEV-319954 |
|
Make a Copy may fail if the document contains annotations with replies. It may also misplace annotations and not copy annotation tags if the document contains area annotations. Re-rendering documents, or merging fields, may drop annotations until the document is re-rendered again if the document contains annotations with replies.
|
DEV-314262 |
|
Under certain conditions, incorrect page size values for rotated pages (90 or 270 degrees) that have a coordinate system with non-zero origins can impact the accuracy of a number of features that depend on page sizes (e.g. BFA, cross-doc navigation, etc.), as well as some bookmark navigation to rotated pages.
|
DEV-327558 |
|
After using the Suggest Links function, Vault may incorrectly indicate that Suggested Links have been added before the job has finished processing.
|
DEV-286280 |
|
Vault does not show a warning when a user removes the last reference from an Approved Claim.
|
DEV-308145 |
|
When adding references to a claim, users see an error message if they select anchors with over 128 characters in the title.
|
DEV-313771 |
|
When selecting anchors for a link annotation, Vault does not correctly show a red minus icon on already-selected anchors if the target document has over three anchors.
|
DEV-310686 |
|
When using the Bring Forward Annotations action, Vault does not bring forward link annotations if the user does not have access to view the linked documents.
|
DEV-307079 |
|
When using the Import Document Links document action, users see a blank screen while Vault loads the data. Users will now see a spinning icon to indicate the action in progress.
|
DEV-308633 |
|
When a video is over 1 hour long, users cannot add a time-stamped comment beyond the 1-hour point.
|
DEV-312394 |
|
In some cases, attempting to archive CrossLink documents may fail.
|
DEV-328550 |
|
When viewing supporting documents, the non-viewable archived and active documents count is incorrect.
|
DEV-333808 |
|
Uploading an attachment with long filenames that include non-English characters may result in a "server having problems" error.
|
DEV-306084 |
|
Documents using many matching sharing rules may result in reduced performance.
|
DEV-302161 |
|
When creating a document from a placeholder, automated language changes based on the document language do not show up in the audit trail.
|
DEV-304095 |
|
When exporting more than 100 documents where there are duplicate documents, the export summary may contain duplicate entries.
|
DEV-308440 |
|
When editing a Binder in the List View, attempting to perform actions after deleting a newly created sibling section results in a server error.
|
DEV-313712 |
|
For vaults using Collaborative Authoring with MS Word, Vault may display an error when a Check Out user clicks Save to Vault for a document checked out prior to the 20R1.3 release.
|
DEV-329365 |
|
Using Collaborative Authoring to check out and then check in the same document may result in an "Unable to check in from Microsoft Office" error due to a permissions issue with Microsoft servers.
|
DEV-302506 |
|
In some cases, users cannot create a binder through bulk action.
|
DEV-307283 |
|
Users with the Edit Relationship permission on the Doc Info page can see the expand icon for the Renditions section.
|
DEV-302512 |
|
When viewing the Doc Info page, an old Template Document Type may show in the UI even after the Template Document Type has been updated.
|
DEV-306749 |
|
Under certain conditions, the Document Relationship Type may be incorrect when performing a comparison.
|
DEV-235588 |
|
Deleting a document version also deletes the document template even when the document version is unrelated to the template.
|
DEV-312025 |
|
In some scenarios, putting a document into steady state with a Template Document Type configured does not create a Controlled Document Template for that document.
|
DEV-303602 |
|
An error may occur if Vault is restarted while a bulk document rendition process is running.
|
DEV-301532 |
|
Copying a document with an inactive or deleted relationship type results in an error.
|
DEV-314407 |
|
In some cases, users cannot upload files larger than 4GB via FTP as Large Size Assets.
|
DEV-313015 |
|
In some cases, documents utilizing the "Add links to Endnotes and Footnotes" option may fail to render.
|
DEV-319052 |
|
Vault fails to send a notification after a Large Size Asset rendition has been uploaded.
|
DEV-297366 |
|
Hidden text in headers and footers which contains hyperlinks may incorrectly display as unhidden in MS Word renditions.
|
DEV-317397 |
|
Under certain conditions, making a copy of a previously copied document may fail and redirect the user to the original document.
|
DEV-310861 |
|
Users are unable to create or update field dependencies when using Vault in the latest version of Chrome.
|
DEV-321662 |
|
In some cases, migrating documents to Vault from an FTP results in an error.
|
DEV-334701 |
|
In some cases, users see an error when attempting to select a related object record from a document field on the Doc Info page.
|
DEV-321513 |
|
In some cases, document checkout headers are not displayed when editing a checked out document in a different browser.
|
DEV-321369 |
|
In some cases, users see a server error when they attempt to update document fields.
|
DEV-313406 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-260841 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-249731 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-246844 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-290446 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-304060 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-273220 |
|
In some cases, Microsoft PowerPoint documents contain formatting issues.
|
DEV-258850 |
|
In some cases, Microsoft PowerPoint documents contain formatting issues.
|
DEV-306295 |
|
In some cases, Microsoft PowerPoint™ documents contain formatting issues.
|
DEV-280907 |
|
In some cases, Vault may fail to export annotations for PDF files with unused images.
|
DEV-288036 |
|
Microsoft Word™ document rendition contains formatting issues.
|
DEV-303848 |
|
Microsoft Word™ document rendition contains formatting issues.
|
DEV-272909 |
|
Microsoft Word™ document rendition contains formatting issues.
|
DEV-276875 |
|
Microsoft Word™ document rendition contains formatting issues.
|
DEV-276746 |
|
Microsoft Word™ document rendition contains formatting issues.
|
DEV-308141 |
|
Source documents are re-rendered when a viewable rendition is manually uploaded.
|
DEV-305860 |
|
Uploaded rendition documents display a size of 0.
|
DEV-279718 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-260187 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-260909 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-259871 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-259218 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-259514 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-253458 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-251131 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-263397 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-241996 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-240914 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-233227 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-288422 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-301100 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-294526 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-308939 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-308239 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-306255 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-303835 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-312185 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-295619 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-272760 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-284817 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-283941 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-274322 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-283034 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-307291 |
|
When rendered with advanced overlays, links within documents are inactive in downloaded viewable renditions.
|
DEV-302018 |
|
Fonts fail to render as expected in a Microsoft Word™ document.
|
DEV-260260 |
|
In rare cases, documents utilizing Merge Fields may not correctly merge upon initial rendering and may require a field update to correct the rendition.
|
DEV-271258 |
|
In some cases, adding a product to a binder results in an error.
|
DEV-313393 |
|
In some cases, merge field tokens in viewable renditions are not generated.
|
DEV-315279 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-279117 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-275583 |
|
In some cases, documents are not updated to reflect changes made after re-rendering.
|
DEV-328797 |
|
In some cases, applying an overlay to a document with fillable fields may remove the values of said fields.
|
DEV-290381 |
|
In some cases, eSignature pages are missing from downloaded viewable renditions.
|
DEV-317262 |
|
In some cases, eSignature pages are not correctly applied to viewable renditions.
|
DEV-297441 |
|
In some cases, PDF/A compliant documents fail to render.
|
DEV-328056 |
|
In some cases. PDF/A compliant documents fail to render.
|
DEV-331214 |
|
Microsoft Word™ document rendition contains formatting issues.
|
DEV-291210 |
|
Vault fails to render Microsoft Word™ document.
|
DEV-235058 |
|
In rare cases, a valid document does not appear in the Library but can be accessed directly through the document URL.
|
DEV-289119 |
|
In some cases, fonts appear squished or collapsed after applying an advanced overlay.
|
DEV-321822 |
|
In some cases, user see a message like "Successfully created 49 of 49 document(s)" when uploading a single document via EDL.
|
DEV-309561 |
|
In Veeva Claims vaults, Vault is unable to add a CrossLink document to an object record.
|
DEV-300817 |
|
In some scenarios, Vault does not replace the major version of a document after executing the Delete Minor Versions action.
|
DEV-322444 |
|
When archiving staged documents, Vault displays "success" to users even though the documents are not archived, as staged documents cannot be archived.
|
DEV-300163 |
|
In some scenarios, automatic document tagging does not tag all of the required documents.
|
DEV-318664 |
|
In some cases, creating a shared document field results in an error.
|
DEV-317134 |
|
Users see an error when performing Create Draft on a CrossLink document if there is an event action configured.
|
DEV-321170 |
|
Timeline View does not display events in the same order as the Audit Logs.
|
DEV-324981 |
| Description |
Issue No. |
|
Exporting Expected Document List hierarchies has decreased performance.
|
DEV-287484 |
|
The Welcome to Veeva Vault email contains a broken link when accessed in Safari.
|
DEV-321693 |
|
In some scenarios, retrieving a document's audit history has slow performance.
|
DEV-309403 |
|
Users receive a server error when creating or removing a related object for Checklist Design objects when there is no specified completed state type for the Checklist Design lifecycle.
|
DEV-301791 |
|
When opening a MS Office file uploaded as an attachment, users see a blank window while Vault generates a rendition.
|
DEV-310898 |
|
Users see a blank screen after uploading a related document from an object record.
|
DEV-315654 |
|
In some cases, validation jobs take longer than expected.
|
DEV-332975 |
|
In some situations, certain elements do not display the translated text in Vault's UI.
|
DEV-308664 |
|
Some vaults may experience poor performance due to an underlying server caching issue.
|
DEV-311810 |
|
In some cases, Vault incorretly reports an error that the maximum token length has been exceeded.
|
DEV-299562 |
|
Exporting to an Excel template takes longer than expected.
|
DEV-325637 |
|
When using the Study Selector in combination with Study/Site filters and document type filters in Tabular view, navigations arrows do not appear.
|
DEV-261367 |
|
Vault performance is sometimes slow when loading lists of object records.
|
DEV-322351 |
|
The lifecycle status indicator in supporting document pop-up dialogs may appear with an incorrect size.
|
DEV-327735 |
|
Under certain conditions, document view metrics may be inaccurate.
|
DEV-275747 |
|
Cells in related record sections may incorrectly display with additional space around the cell content.
|
DEV-327900 |
|
Control icons such as edit, close, and add within sections on object page layout configuration pages may not display as expected in IE11.
|
DEV-315398 |
|
Exporting a large report to an Excel template takes longer than expected.
|
DEV-319811 |
|
For some users, the Product Announcements and Service Availability notification options may inadvertently change when saving their profile.
|
DEV-317355 |
|
Horizontal scrolling in related record sections may be slow for sections with a large number of columns.
|
DEV-331133 |
|
Hovering over a field in a related record section of an object details page may incorrectly display an additional border line.
|
DEV-327901 |
|
In some cases, clicking on the link to an attachment from the document viewer takes the user to their Home tab instead of to the attachment.
|
DEV-320344 |
|
In some cases, flash reports take longer than expected.
|
DEV-316078 |
|
In some cases, the "Back to <object>" navigation link may not correctly appear when navigating from a related record section to a document page.
|
DEV-323245 |
|
Under certain conditions, some users are unable to login after creating large vaults from an export package.
|
DEV-313693 |
|
Users may experience reduced performance when resizing columns in related record sections.
|
DEV-331018 |
|
In some view configurations, tasks in custom task views may not be clickable as expected.
|
DEV-313292 |
|
Generating formatted output and exporting binders may take an inordinate amount of time.
|
DEV-314835 |
|
The left and right arrow keys do not correctly scroll horizontally in the updated record picker dialog.
|
DEV-315008 |
|
In some cases, the Unsaved Changes warning prompt does not appear upon leaving an edited record page.
|
DEV-319537 |
|
The `ls` command fails to list files and hangs for some FTP client directories.
|
DEV-303671 |
|
In certain situations, the "Name" field is missing from the related object records grid and users cannot access the Actions menu.
|
DEV-317559 |
|
Users see a server error, rather than an informative error message, when trying to perform an action that will result in an entry action on a document to which they don't have access.
|
DEV-321737 |
|
Creating a binder from a template may take longer than expected.
|
DEV-317128 |
|
When entry actions or entry criteria are configured on the Quality Event Lifecycle, Vault is slow to complete tasks that result in state changes.
|
DEV-302712 |
|
A query may fail if started while Vault is already processing a very large job, such as reconciling contextual fields on a very large number of documents.
|
DEV-286073 |
| Description |
Issue No. |
|
In some scenarios, a published STF may appear duplicated in the published output.
|
DEV-318982 |
|
Sometimes, Vault does not create the expected number of sections when copying a content plan.
|
DEV-222148 |
|
When users create object lifecycle state entry actions, Vault incorrectly includes the "Resubmit spark message" option in the list of available actions.
|
DEV-314251 |
|
In some scenarios, Vault does not display documents after clicking on a bookmark in the Submissions Archive Viewer.
|
DEV-314076 |
|
In the new Content Plan Hierarchy Viewer, users experience slow performance when expanding content plan sections with many children.
|
DEV-299753 |
|
In some cases, device-specific fields that are hidden from users prevent users from creating Registered Packaging records through the Manage Registered Details wizard.
|
DEV-315984 |
|
In some cases, Vault does not update the Regulatory Objective field when a user performs the Manage Registered details action.
|
DEV-319303 |
|
Submissions-specific change related active object lifecycle state configuration does not work with Conditions on Related Records, resulting in Vault displaying a server error.
|
DEV-318377 |
|
Users experience an error when importing submissions if the XML contains a reference preceded by "./".
|
DEV-318607 |
|
In vaults with the QMS to Registrations Spark Connection configured, Vault incorrectly truncates some Long Text fields when creating object records in the target vault.
|
DEV-323527 |
|
In some cases, users can't create Regulatory Objective or Submission records in the Create Related Records wizard because filters in the wizard conflict with custom Criteria VQL on certain fields.
|
DEV-309036 |
|
In some cases, users receive an error when attempting to import a dossier to a Submission record.
|
DEV-321570 |
|
Vault changes the capitalization of the Leaf ID in the stf.xml file after a submission is published.
|
DEV-312993 |
|
Vault does not support multi-value picklist fields in the Create Registrations wizard.
|
DEV-318455 |
|
If an Admin has modified the Lifecycle State field label, Vault doesn't show the updated label in the Update Fields dialog within the Manage Registered Details wizard.
|
DEV-309632 |
|
In the Manage Registered Details wizard, users are unable to double click the Lifecycle State field in the grid to open the Update Fields dialog for some Registered Details records.
|
DEV-303151 |
|
In the Manage Registered Details wizard, users cannot create Registered Drug Product join records for a Registration that has related complex drug products and simple drug products.
|
DEV-301395 |
|
In the Manage Registered Details Wizard, users see an error when they click the Update Fields button if records are selected but the Country row is collapsed.
|
DEV-307399 |
|
Some users experience slow performance when bundling regulatory objectives.
|
DEV-302695 |
|
The Summary page in the Manage Registered Details wizard appears blank when users select Registration records with no selected records in the Product Variant or Product fields.
|
DEV-309362 |
|
Users can't clear object-type fields using inline editing in the Manage Registered Details wizard grid panes.
|
DEV-328186 |
|
Users without the Read permission on the Event Regulatory Objective object see an Errors Encountered result when they attempt to create Regulatory Objective records via the Create Related Records wizard.
|
DEV-309811 |
|
Vault sometimes creates the same leaf twice in a submission rather than replacing the file.
|
DEV-307422 |
|
When Dynamic Access Control is configured, Vault includes records on which users lack the Read permission in the Add: Registered Details dialog within the Manage Registered Details wizard.
|
DEV-319603 |
|
When users add new details in the Manage Registered Details wizard, the blue information icon doesn't appear next to updated records to allow users to view or modify their changes.
|
DEV-330845 |
|
When users run the Create Related Records wizard and create activities with the Activity Scope Level set to Country, Vault relates too many registrations to each activity.
|
DEV-322379 |
|
In some cases, the XEVMPD bulk update process fails when multiple Medicinal Products are linked to a Vault document.
|
DEV-302280 |
|
Vault fails to create a Product Report with 500 or more Product Report Item records at the same level in the hierarchy.
|
DEV-327959 |
|
When generating a product report, users receive an error for the Presentation Name Element if Language Codes are not capitalized.
|
DEV-303390 |
|
In some cases, users experience slow performance when creating a Content Plan.
|
DEV-307723 |
|
When creating a Submission record from the related object section on the Regulatory Objective object record detail page, and vice versa, users now see the Create button instead of the Add button.
|
DEV-338971 |
|
When creating a Submission record from the related object section on the Regulatory Objective object record detail page, and vice versa, users now see the Create button instead of the Add button.
|
DEV-338971 |
|
After continuous publishing or the Manage Submission Administrative Information job, Vault incorrectly changes the STF_Info on an Australian Submission from Informational to Fail.
|
DEV-303427 |
|
After initially failing during validation, Vault deletes some Submission Validation Result records rather than updating them to the Pass status when validation runs again.
|
DEV-311952 |
|
After publishing a submission, clicking the View Document link the Detailed Publishing Results section opens the document in both the current page and a mini-browser window.
|
DEV-329306 |
|
After unmatching a document, continuous publishing does not update the submission metadata, and the incorrect checksum results in Vault reporting Rule 1374 for the content plan item.
|
DEV-328188 |
|
After users set criteria to inactive, running on-demand publishing does not update validation results.
|
DEV-322939 |
|
In some cases, after publishing a submission, Vault doesn't populate submission metadata on STF leaf nodes.
|
DEV-302100 |
|
In some cases, the checksums for published documents are incorrect after continuous publishing runs.
|
DEV-328075 |
|
In some RIM vaults, the Workflow Timeline section is missing from some Regulatory Objective object type page layouts.
|
DEV-317066 |
|
In the Set Leaf Operation Target dialog, sections with long names display incorrectly.
|
DEV-326717 |
|
In the Submission Administrative Information viewer, Vault should display excluded values at the bottom of the screen.
|
DEV-274059 |
|
In the Submissions Archive Viewer, when users apply filters and then select All in that filter, Vault doesn't return to the root level and instead displays the section that was open previously.
|
DEV-318158 |
|
The Select Leaf Operation Target dialog sometimes appears blank, and users can't select a leaf target from the imported submission.
|
DEV-330318 |
|
Vault does not trigger continuous publishing and update the EU Regional XML when a user deletes a Submission Drug Product record and the Dossier Status field on the related Submission is set to Publishing Active.
|
DEV-233061 |
|
Vault doesn't report rule CA F09 as Fail if a user updates the Sequence Description to a different letter case in the Submission Administrative Information viewer.
|
DEV-305989 |
|
Vault doesn't update the binder structure correctly when a user sets an STF XML Content Plan Item record to Inactive.
|
DEV-275240 |
|
Vault fails to report EU rule 16.BP10 when the PDF contains JavaScript in a bookmark or hyperlink.
|
DEV-262038 |
|
Vault incorrectly publishes documents that are matched to Content Plan Items with the XML Operation field set to Delete.
|
DEV-325703 |
|
When a published CH submission has a Submission Country join record, the Agency and Article 13 TPA fields appear blank in the XML and in the Submission Administrative Information viewer.
|
DEV-303623 |
|
When a submission includes more than 1,000 documents, Vault only publishes the first 1,000 documents.
|
DEV-323222 |
|
When a user excludes overrides on one submission, Vault does not exclude them when users save overrides on subsequent submissions.
|
DEV-323159 |
|
When a user sets or clears the Continuous Publishing field to enable or disable continuous publishing, Vault takes more than 30 minutes to process the change.
|
DEV-328041 |
|
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 |
|
When users publish a submission, Vault includes inactive Submission Country records in the Submission Administrative Information envelope.
|
DEV-305885 |
|
When users set the Continuous Publishing field to "No", Vault incorrectly runs the continuous validation job.
|
DEV-307559 |
|
When users update the Continuous Publishing field from "No" to "Yes" for the Index.xml Content Plan Item on a published submission, continuous publishing fails to publish the Index.
|
DEV-267467 |
|
While attempting to set the XML operation to append, delete, or replace and attempt to use the Set Leaf Operation on a Content Plan Item, users receive an error message stating, "Your vault has experienced a network issue. Please refresh your browser and try again. If this error continues to appear, contact Veeva Support."
|
DEV-324083 |
|
After a user removes a matched document from the Content Plan Item record detail page, it still appears in the Content Plan Hierarchy Viewer when users expand the parent Content Plan record until the page is refreshed.
|
DEV-301121 |
|
After merging PDF documents part of report level content plan publishing, the link in the Vault notification takes the user to a blank page with a Page not Found error instead of the Hierarchy Viewer.
|
DEV-317486 |
|
After users select a document in the Dossier Review Panel, Vault navigates them back to the top of the panel.
|
DEV-314661 |
|
In some cases, publishing fails when there is a bookmark or link to an invalid named destination across the application.
|
DEV-314657 |
|
In some cases, the Create Content Plan action may not create all of the expected Content Plan Items on all Content Plans.
|
DEV-190723 |
|
In some cases, users experience slower than usual performance when exporting large Content Plans.
|
DEV-261984 |
|
Report level publishing fails with a "No target document found for this permalink" error when a document link points to two different target documents.
|
DEV-303994 |
|
Sometimes, the Actions menu for a record in the Hierarchy Viewer grid doesn't open the first time the user clicks the gear icon.
|
DEV-291283 |
|
Users experience slow performance when filtering on Matched Document fields in the new Content Plan Hierarchy Viewer.
|
DEV-303754 |
|
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 |
|
Vault doesn't set the name of the root Content Plan record correctly if a user selects the Create Content Plan action or the Copy Content Plan action and content plan creation fails.
|
DEV-261886 |
|
Vault fails to create and publish a merged PDF as part of report level content plan publishing when a user only has the Editor role on one of the merged documents.
|
DEV-314423 |
|
When a user deletes the root Content Plan record in the Content Plan Hierarchy Grid Viewer, Vault does not return the user to the related Submission record or Report Level Content Plan record.
|
DEV-310617 |
|
When copying a content plan for an EU submission from a content plan for a US submission, the content plan structure is incorrect.
|
DEV-243072 |
|
When copying a content plan, Vault fails to create a Content Plan Item record if it was excluded under an inactive parent Content Plan record in the source Content Plan.
|
DEV-309287 |
|
When users filter by a Matched Document field in the new Content Plan Hierarchy Viewer, the icon for the matched document's Content Plan Item record in the name column appears collapsed instead of expanded.
|
DEV-306234 |
|
In some cases, Vault appends extra characters to imported submission files.
|
DEV-318226 |
|
In some cases, Vault doesn't export files when users perform bulk submission exports.
|
DEV-308089 |
|
The "Show eCTD Metadata Mapping to users on submission import" enablement checkbox does not appear on the Admin > Settings > Application Settings page.
|
DEV-311028 |
|
The Job Status for the Submissions Archive Bulk Export job shows as Running when the job has completed with an error.
|
DEV-302156 |
|
The Manufacturer attribute doesn't appear in the Viewer for published submissions.
|
DEV-241316 |
|
Users receive an error when attempting to import a submission to a Submission record that has a blank required custom field.
|
DEV-299286 |
|
Users see an error when they open and expand the Dossier Review Panel from the Submissions Archive Viewer.
|
DEV-303752 |
|
Validation rule EU 15.BP3 reports as Pass incorrectly for certain filenames.
|
DEV-320919 |
|
Vault does not include all forms when a user exports a grouped US submission.
|
DEV-310750 |
|
Vault fails display applied filter values under the header in the Submissions Archive Viewer when users select a single filter value.
|
DEV-303695 |
|
After importing a submission dossier using Vault File Manager, hyperlinks and bookmarks in the submission content lead to a "Document Not Found" page.
|
DEV-329420 |
|
In some cases, Vault reports an error when users import a submission via the FTP.
|
DEV-309439 |
|
Submission imports succeed even when the Submission record has an empty required field.
|
DEV-323720 |
|
Users do not see a warning in the Vault notification when they attempt to bulk import the same submission to multiple submissions within the same application.
|
DEV-283943 |
|
Users experience slow performance when importing submissions in bulk.
|
DEV-308645 |
|
Vault fails to import a subsequent submission when documents have the same href attribute but different checksums across the submission.
|
DEV-306973 |
|
Vault includes an unnecessary warning after users import a submission that contains a document that already exists in Vault.
|
DEV-302948 |
|
When the "Show eCTD Metadata Mapping to users on submission import" setting is not enabled on the Application Settings page, Vault does not display the submission mapping page when users import a grouped submission.
|
DEV-306706 |
|
When users upload an eCTD submission folder from Vault File Manager, Vault does not import it properly.
|
DEV-327907 |
|
In the Dossier Panel, Vault automatically expands sections that were recently collapsed when users select a document in a different section.
|
DEV-313951 |
|
In the Submissions Archive Viewer, users can duplicate files when viewing All Submissions.
|
DEV-310879 |
|
Users experience slow performance when they click Expand All in the Submissions Archive Viewer.
|
DEV-303399 |
|
Users with the Read permission on the Submission Metadata object cannot add a filter in the Submissions Archive Viewer.
|
DEV-304140 |
|
When the Show Correspondence in Viewer setting is enabled, Vault does not append the Submission name to the document name in the Submission Archive Viewer.
|
DEV-323840 |
|
In configurations where the Relate Multiple Records setting is enabled on the Submission Inactive Ingredient object, Vault shows a server error when users add an inactive ingredient to a submission product.
|
DEV-323151 |
|
After initially failing during validation, Vault deletes some Submission Validation Result records rather than updating them to the Pass status when validation runs again. This fix includes additional cases not included in DEV-311952 from 20R1.0.8.
|
DEV-318423 |
| Description |
Issue No. |
|
Fixed an issue where the Date Picker did not close after selecting a Receipt Date on the AER.
|
SAF-3954 |
|
Fixed an issue where, when tabbing out of the Dose and Indication selection in Case Product, the fields were being cleared.
|
SAF-4702 |
|
Fixed an issue where the combined MedDRA control could not be created or updated in the Case Product Indication Section Control.
|
SAF-5079* |
|
Fixed an issue that was causing a “ProtectedRollbackException” error when promoting an AER to a Follow-Up Case.
|
SAF-5444* |
|
Fixed an issue where Follow-Up Cases promoted from a non-E2B AER did not have the Case Number populated.
|
SAF-5501* |
|
Fixed an issue where a "Product record not found" error appeared when promoting an E2B AER with a high number of Case Products with dosages.
|
SAF-5526* |
|
Fixed an issue where, if a preconfigured Study Site had a blank Registration field, a NullPointerException error was appearing when users tried to complete the Triage task.
|
SAF-5620 |
|
Fixed an issue where the Age at Onset field was not being recalculated correctly on Cases imported from an E2B file with multiple Case Adverse Event records.
|
SAF-5632 |
|
Fixed an issue where a State name was misspelled on the Aggregate Template Lifecycle.
|
SAF-5662 |
|
Fixed an issue where the “Transmission Profile already exists” error was displaying incorrectly.
|
SAF-5662 |
|
Fixed an issue where a descriptive error message did not appear below the MedDRA field when a non-primary MedDRA term was selected for a Case Adverse Event.
|
SAF-5735* |
|
Fixed an issue where the AESI Watchlist Tag was unable to be added on Study cases.
|
SAF-5741* |
|
Fixed an issue where, when a Dosage is marked for deletion, the delete overlay of Dosages is misplaced on the screen after expanding or collapsing the above subsection.
|
SAF-5759* |
|
Fixed an issue where users could create duplicate Cases by clicking “Back to the previous page" after promoting an AER to a Case.
|
SAF-5781 |
|
Fixed an issue where the Case Expedited field was being populated when the Event MedDRA was on the DME watchlist and the Product Registration Agency was FDA.
|
SAF-5802 & SAF-5795 |
|
Fixed an issue where, when three keywords were inputted in the MedDRA search bar, no results were shown.
|
SAF-5827* |
|
Fixed an issue where the selected MedDRA term was not shown in results upon exiting and re-entering the browser.
|
SAF-5828* |
|
Fixed an issue where, when an AER was promoted to Case with an empty Seriousness field, the Expectedness field on the resulting field was set to Yes if there were no preconfigured Product Datasheets.
|
SAF-5834 |
|
Fixed an issue where the coded value of the MedDRA term was not shown in results upon exiting and re-entering the browser.
|
SAF-5850* |
|
Fixed an issue where, when a MedDRA term was coded to a non-primary SOC, the term was not shown in results upon exiting and re-entering the browser.
|
SAF-5854* |
|
Fixed an issue where users were unable to open links to documents or Cases from vault notifications.
|
SAF-5874 |
|
Fixed an issue where, when Adverse Events on Study and Literature Cases did not have a Case Assessment, they were not counted on the PSUR Summary Tabulation.
|
SAF-5875* |
|
Fixed an issue where the Binoculars icon next to the Event (Reported) field was missing on MedDRA control.
|
SAF-5893* |
|
Fixed an issue where, when the Case Product registration was updated, the system set the Expedited flag to NO instead of leaving the Expedited flag as-is.
|
SAF-5904* |
|
Fixed an issue where a server error appeared when a user assigned the Lock Manager role tried to create an AER.
|
SAF-5907* |
|
Fixed an issue where Null appeared on CIOMS II listings when Event MedDRA was not provided on the case.
|
SAF-5921* |
|
Fixed an issue where, when trying to change the MedDRA Query Level, the record did not update and an incorrect success message appeared instead of displaying a valid error message.
|
SAF-5929 |
|
Fixed an issue where PSUR reports failed to generate when a non-serious case has the Expectedness field left blank.
|
SAF-5933* |
|
Fixed an issue where the Adverse Event was exported with Event MedDRA instead of in format Event Reported (Event MedDRA) when generating PSUR Summary Tabulations.
|
SAF-5950* |
|
Fixed an issue where a Study Case Product on Open case went to Unblinded lifecycle state instead of Open lifecycle state.
|
SAF-5968* |
|
Fixed an issue where the user was unable to change the state of the case to Approved once the user locks the case.
|
SAF-5985* |
|
Fixed an issue where the system was automatically generating Submission records for non-SUSAR and non-SAE Follow-Up Cases.
|
SAF-5988 |
|
Fixed an issue where, when evaluating reporting obligations, the Case Adverse Event was not being filtered based on agency country.
|
SAF-6003* |
|
Fixed an issue where the selected MedDRA term was not displayed on the first page after re-opening the browser.
|
SAF-6038* |
|
Fixed an issue where users could select invalid Reason Omitted (nullflavor) values from combined control fields during data entry.
|
SAF-6043 |
|
Fixed an issue where the Case page could not load when the Medical Review Timeline section control was added to the Case page layout.
|
SAF-6049* |
|
Fixed an issue where users were not receiving a warning notification when uploading a Narrative Document in an unsupported format.
|
SAF-6055 |
|
Fixed an issue where “highcharts.com” was displayed at the bottom right corner of the Medical Review Timeline section.
|
SAF-6075* |
|
Fixed an issue where, when using B.4.k.5.3 in an E2B (R2) file, product dosages were aggregated on import.
|
SAF-6078 |
|
Fixed an issue where the Medical Review Timeline Header was not displayed correctly when the Case Adverse Event contained a start and end date.
|
SAF-6079* |
|
Fixed an issue where, when the Case Adverse Event had the same start and end date, the Medical Review Timeline bar was empty instead of displaying a Milestone Marker.
|
SAF-6080* |
|
Fixed an issue where the Date Range field for the Medical Review Timeline was misplaced on the screen when the user tried to edit it.
|
SAF-6094* |
|
Fixed an issue where the Medical Review Timeline hovercard only displayed the year value when the Onset date of the Case Adverse Event was the first day of any month.
|
SAF-6095* |
|
Fixed an issue where different Expectedness values were being populated on initial Cases and their corresponding Follow-Up Cases.
|
SAF-6096 |
|
Fixed an issue where the End date was calculated incorrectly when the Case Adverse Event contains an Onset date and Outcome is Unknown or left blank.
|
SAF-6103* |
|
Fixed an issue where the Date values in the Medical Review Timeline hovercard were displayed incorrectly when the Case AE contains an Onset or Cessation date and Duration < 1 day.
|
SAF-6116* |
|
Fixed an issue where, when the Case Adverse Event had Onset Date and Outcome: “recovered/resolved” or “recovered/resolved with sequelae”, the Timeline bar is empty instead of displaying the Milestone Marker.
|
SAF-6119* |
|
Fixed an issue where after you manually changed the auto-calculated Expected field to set the value to Yes (Overriden), the system updated the Expedited field to No instead of leaving the Expedited field as-is.
|
SAF-6123 |
|
Fixed an issue where a server error appeared when a Case Product Dosage did not have a Frequency Value and a First Admin Date.
|
SAF-6124* |
|
Fixed an issue where the Dosage Details on the Medical Review Timeline contained extra decimals compared to the Dosage Details of the Case Product.
|
SAF-6125* |
|
Fixed an issue where generated CIOMS I forms showed both the two-letter country code and the country name in the address fields. Now, the system populates the country name only without the country code.
|
SAF-6138 |
|
Fixed an issue where the Assessment Result of an AER did not copy over when a user opened a new Study Case.
|
SAF-6144* |
|
Fixed an issue where you could not create a Follow-Up Case from a Case containing multiple Case Product or Case Adverse Event records with identical names.
|
SAF-6157 |
|
Fixed an issue where a server error appeared when multiple dosages are updated or created on Case Product and result in auto-calculation.
|
SAF-6168* |
|
Fixed an issue where a system error appeared when trying to create a follow up Adverse Event Report from potential matches with a different Adverse Event MedDRA.
|
SAF-6179* |
|
Fixed an issue where the Title field for Case Narratives was not being populated correctly.
|
SAF-6223* |
|
Fixed an issue where a SOC product in a blinded study case was getting created as Blinded instead of Open.
|
SAF-6255* |
|
Fixed an issue where a duplicate Case Adverse Event record was created on the follow-up case when the auto-calculated Expected value was updated on the original case.
|
SAF-6257* |
|
Fixed an issue where Non-Expedited Closed Cases with SAE tags changed to Expedited upon creating Follow-Ups.
|
SAF-6341 |
|
Fixed an issue where the audit log recorded that the system created Follow-Up Cases instead of the user who triggered the action.
|
SAF-6344 & SAF-6535 |
|
Fixed an issue where the system was not automatically calculating the Latency field on Case Assessment records after a Case was created from an imported E2B file.
|
SAF-6374 |
|
Fixed an issue where the system was incorrectly populating Relatedness as "Unknown".
|
SAF-6447 |
|
Fixed an issue where a descriptive error message did not appear when Follow-Up Case creation failed due to a Case field referencing an inactive Controlled Vocabulary record.
|
SAF-6449 |
|
Fixed an issue where E2B (R3) files were failing to import if a Case Product was linked to a different Organization than the E2B document in the vault library.
|
SAF-6484 |
|
Fixed an issue where, when importing EMA E2B (R3) where Assessment Results use E2B Codes instead of plain text, values from the file were not always mapped to the respective default E2B code.
|
SAF-6528 |
|
Fixed an issue where cumulative case calculations were not considering the correct start date when generating aggregate reports.
|
SAF-6605 |
|
Fixed an issue where the interval column did not include the latest New Info Date in range for PBRER Number of Product Reactions by Term for Postmarketing Sources table.
|
SAF-6648 |
|
Fixed an issue where an error message appeared without stating the actual cause of the error after creating a Follow-Up Case with two open Case versions.
|
SAF-6669 |
|
Fixed an issue where a Submission record was not automatically generated for Follow-Up Cases when the initial imported Case did not have a Submission.
|
SAF-6672 |
|
Fixed an issue where a failure notification did not appear when a user tried to generate an FDA 3500A form from a Case where a Device-type Product is the only and primary Case Product.
|
SAF-6794* |
|
Fixed an issue where a Read-only Value field was left blank in Case Product when its Unit field was blank. Now, the system will issue an “Invalid” icon when a Unit field is left blank.
|
SAF-6804 |
|
Fixed an issue where EMA EVWEB XSD validation failed after selecting “Cyclical”, “As Necessary”, or “Total” for Frequency instead of a value.
|
SAF-6806 |
|
Fixed an issue where a server error appeared when a user without permissions to read User security tried to create records on Safety objects with an api_name field.
|
SAF-6828 |
|
Fixed an issue where a server error appeared when a user tried to view Case Product page from VMC > View Configuration.
|
SAF-6832 & SAF-6158 |
|
Fixed an issue with Study Report Types where Submission records were being created on Follow-Ups if the initial Case had a completed Submission, even if it was not tagged as SUSAR. This fix does not affect the current behaviour for Post-Market Report Types.
|
SAF-6834 |
|
Fixed an issue where blank EMA E2B (R3) fields were included in the XML file and caused an EMA submission failure.
|
SAF-6923 |
|
Fixed an issue where, when a new Adverse Event was added to a Case, the system was not automatically calculating the Latency field.
|
SAF-6927 |
|
Fixed an issue where you could not use the pagination input box in the MedDRA browser to navigate to a different result page.
|
SAF-7041* |
|
Fixed an issue where, when a non-primary Adverse Event or Product was updated to primary, Case level Expectedness was not updated.
|
SAF-7042* |
|
Fixed an issue where a system error appeared when trying to create a Distribution from Combination Products with a registration and reporting Organization set.
|
SAF-7098* |
|
Fixed an issue where the Product Code in Combination Products with Device Constituents was not getting exported in the FDA E2B (R2) file.
|
SAF-7125* |
|
Fixed an issue where the Combination Products’ Device Constituent fields were getting exported in the Health Canada E2B (R2) file.
|
SAF-7132* |
|
Fixed an issue where, when using MedDRA Auto-code to search for a term, the term is coded as “Non-Primary”.
|
SAF-7142* |
|
Fixed an issue where the acknowledgment failed to generate when importing E2B files through Vault API or AS2 Gateway.
|
SAF-7169* |
|
Fixed an issue where, when a user navigated to the next page in the MedDRA browser and then changed the filter level (i.e. from SOC-level to LLT-level), no results were shown.
|
SAF-7182* |
|
Fixed an issue where the Manufacturer tag was missing in E2B (R2) files generated for Cases regarding a combination Product with Device Constituent.
|
SAF-7231* |
|
Fixed an issue where a user could successfully edit the Name (Reported) field when their Edit Object Field permission was disabled.
|
SAF-7232 |
|
Fixed an issue where a user could successfully delete an Object when their Delete permission was disabled.
|
SAF-7236 |
|
Fixed an issue where a server error appeared when navigating to the Case page after Read permission was removed from the Name (MedDRA) field in the Indications subsection.
|
SAF-7242 |
|
Fixed an issue where an error appeared when uploading an EMA E2B (R3) XML file to EVWEB and submitting the same file through EMA Gateway.
|
SAF-7279 |
|
Fixed an issue where a console error appeared when a user entered a numeric value in a Unit Picker field.
|
SAF-7319 |
|
Fixed an issue where the Frequency text and drop-down fields remained visible on screen after deleting the Dosage overlay.
|
SAF-7320* |
|
Fixed an issue where, when a Case contained more than one Case Assessment with the same outboundRelationship fields populated (i.e. Start and End Date, Recurrence), the outboundRelationship fields were exported in an incorrect order in the generated E2B (R3) file.
|
SAF-7322 |
|
Fixed an issue where, when a user navigated to the next page in the MedDRA browser and then searched for a new term, no results were shown.
|
SAF-7336* |
|
Fixed an issue where, when Malfunction was selected for Device Report Type, both Adverse Event and Product Problem were selected in the FDA 3500A form instead of Product Problem only.
|
SAF-7356* |
|
Fixed an intermittent issue where Transmission documents were not automatically generated from FDA and EMA Submissions.
|
SAF-7357* |
|
Fixed an issue where an E2B import failed when importing an E2B file with an invalid Date of Birth value.
|
SAF-7360 |
|
Fixed an issue where the Medical Review Timeline did not display the Case Product and its respective Product Dosage.
|
SAF-7389* |
|
Fixed an issue where the text was not fully displayed in the Remedial Action-Other field on the FDA 3500A form generated from a Transmission.
|
SAF-7404* |
|
Fixed an issue where the MedDRA Dictionary was not being consolidated with previously loaded versions, resulting in duplicate entries in the DME List.
|
SAF-7424 |
|
Fixed an issue where Adverse Events were not being included in Case headlines upon E2B Import if a MedDRA Event was not selected.
|
SAF-7439 |
|
Fixed an issue where reporting rules were generating additional Submissions and Distributions on Follow-Up Study Cases when the Study was not associated with those reporting rules.
|
SAF-7445 |
|
Fixed an issue where Transmission records were being created for all products and studies regardless of registration, country, or agency. Now, Transmission records are only created when studies or products are registered in association with Cases.
|
SAF-7453 |
|
Fixed an issue where the audit log was not turned on for Admin objects.
|
SAF-7474 |
|
Fixed an issue where users were unable to save Case Product when they entered a custom Dosage unit.
|
SAF-7500 |
|
Fixed an issue where, when generating an ICH or EMA E2B (R3) file, the Start and End date fields in the Case Adverse Event record were exported as invalid E2B values in section E when these fields had nullflavors. Also, when the Case Adverse Event record contained only the End date and Duration values, the corresponding Section E data elements were exported in an incorrect order.
|
SAF-7502 |
|
Fixed an issue where the audit log was not turned on for system-managed objects.
|
SAF-7540 |
|
Fixed an issue where Case Products could not be saved if the Dosage subsection was populated with a custom entry.
|
SAF-7550 |
|
Fixed an issue where the Gender field value was not appearing on AER or Cases for non-Vault Owners when it was marked as deprecated by a Vault Owner.
|
SAF-7602* |
|
Fixed an issue where, when multiple Dosages overflowed from Section C.3 of FDA 3500A forms onto an additional page, this page would go missing.
|
SAF-7840 |
|
Fixed an issue where, when Adverse Events on Study and Literature Cases did not have a Case Assessment, they were not counted on the PSUR Summary Tabulation.
|
SAF-7887 |
|
Fixed an issue where Superseded initial versions of Cases were not being included in cumulative PBRER and PADER reports.
|
SAF-7897 |
|
Fixed an issue where, when an Administrator changed the active MedDRA version, the MedDRA version was not appearing on Cases.
|
SAF-7966* |
|
Fixed an issue where any user was able to edit or delete records associated with the Device Code Object.
|
SAF-8023 |
|
Fixed an issue where the Organization field was not required on the MedDRA Criteria object.
|
SAF-8334 |
|
Fixed an issue where Patient Initials/ID instead of Investigational MRN was appearing as Patient ID on DSUR Line Listings and Appendix if both fields were populated.
|
SAF-8484 |
|
Fixed an issue where the “Determine Due Date” action was calculating the Case Due Date incorrectly.
|
SAF-8501 |
|
Fixed an issue where the Patient RoA field was not being exported correctly for HC E2B (R2) exports.
|
SAF-8519 |
|
Fixed an issue where Cases with Start Dates/End Dates after Receipt Dates were not being included in PSUR reports.
|
SAF-8596* |