The issues listed below are fixed in the 22R2 release.
| Description |
Issue No. |
|
Vault does not generate a notification after the Recalculate Enrollment Metrics job completes.
|
DEV-332643 |
|
In some cases, a server error displays when a Monitoring Event has multiple Trip Report Question Responses that reference the same Question.
|
DEV-456260 |
|
In some cases, Vault shows a blank page in the Review Summary section of a Monitoring Event.
|
DEV-462947 |
|
In some cases, the Vault incorrectly logs the email address of external users viewing Safety Distributions as external@user.com.
|
DEV-463654 |
|
In some cases, the TMF Homepage Quality widget takes longer than expected to load.
|
DEV-465850 |
|
In some cases, updating crosslinks in Clinical Vaults creates duplicate crosslinks in connected Regulatory Vaults.
|
DEV-467662 |
|
In some cases, inbound documents integration with a RIM Vault will fail and users will be unable to receive inbound documents in the RIM Vault.
|
DEV-468382 |
|
In some cases, Site Connect fails to generate Agreements for correctly configured connections.
|
DEV-469980 |
|
In cases where Enable Deleted Records Transfer is enabled and the Last Successful Run Date for a given integration was more than 30 days ago, updating records on the Clinical Operations side of the CDMS & Clinical Operations Vault Connection fails.
|
DEV-470728 |
|
In some cases, when attempting to add a User to a Person record, Vault displays "Server having problems."
|
DEV-471205 |
|
Vault incorrectly reports during Document Reconciliation that the Clinical Operations Vault has not received the current Steady State document from SiteVault.
|
DEV-474996 |
|
Vault incorrectly requires the Indication Code / 薬効分類番号 on CTN Combination Product records when included in a Generated CTN Document.
|
DEV-475107 |
|
While Enable Timeliness Document Field Calculation is enabled, Vault fails to update the Timeliness field if the Start Date field or End Date field is empty.
|
DEV-475716 |
|
In some cases, Monitored Subject dates do not update as expected after the related Subject records are updated.
|
DEV-476641 |
|
After successfully retrying a TMF Transfer with over 200 Transfer Failure records, Vault fails to delete more than 200 Transfer Failure records.
|
DEV-479621 |
|
In cases where a Study Person record does not have an underlying User record, updates to the Study Person record fail.
|
DEV-479953 |
|
In some cases, Vault creates multiple Transfer Failure records after the user has taken the retry action.
|
DEV-480130 |
|
Drag & drop functionality does not work for expected documents in list view.
|
DEV-480403 |
|
Users receive a server error when attempting to deactivate an agreement that does not exist in the associated Vault.
|
DEV-480674 |
|
Vault shows an unneeded period (.) in the radio button cells of the USN selection dialog.
|
DEV-480782 |
|
When Site Connect is disabled, Vault displays "Server having problems" when loading a page layout containing the Site Document Exchange section.
|
DEV-482002 |
|
Vault may double fetch data and incorrectly generate Weekly MOT records.
|
DEV-482704 |
|
Checklist creation may fail if triggered indirectly via a different workflow.
|
DEV-483736 |
|
Users are unable to mark documents rescinded in cases where the site lifecycle stage is null and the documents have been sent to multiple sites.
|
DEV-484362 |
|
In some cases, documents are incorrectly marked as in bulk queue when they are not being processed.
|
DEV-485030 |
|
In some cases, users are able to create crosslink documents without the required Study field
|
DEV-486201 |
|
Users may receive Unexpected Errors when attempting to perform document reconciliation.
|
DEV-486473 |
|
In some cases involving high volume, CDX uploads fail.
|
DEV-487368 |
|
In some cases, users experience performance degradation when performing certain VQL queries on CDMS Vaults.
|
DEV-487985 |
|
In some cases, the EDL Matching job incorrectly updates EDLs that are Inactive.
|
DEV-488153 |
|
In cases where Actual Metrics have a value of Null, the Update Metrics Job fails.
|
DEV-488431 |
|
Users may receive "Server having problems" errors when completing tasks with entry actions that modify Study Hierarchy values.
|
DEV-488967 |
|
When users update the First and Last Name fields on the User object, Vault does not apply those changes to the Study Person Name field on the Study person object.
|
DEV-489487 |
|
In some cases, hovering over the Milestone progress icon results in "server having problems."
|
DEV-491305 |
|
Reports display groupings incorrectly.
|
DEV-495541 |
|
When users delete a metric at the Study Site level, Vault does not delete the metric after running the Update Metric Job and instead sets the value of the deleted metric to 0.
|
DEV-497262 |
|
Users may receive a server error when using some date filters on Site Activation Progress Reports.
|
DEV-497979 |
|
When the Enhanced Document Update flag is Off, users cannot add a Document from a Study.
|
DEV-499905 |
|
In some cases, users receive an error when attempting to accept an agreement invitation for a clinical Vault in the site Vault.
|
DEV-500981 |
|
In some cases, users without the Manage Archive permission are unable to perform the Send for Review & Approval action on non-Archived studies.
|
DEV-501111 |
|
Users may receive a connection error when attempting to transfer some document types using certain integrations.
|
DEV-501143 |
|
In some cases where the document field maximum value for Timeliness is smaller than the Timeless calculation, Vault does not display an error message.
|
DEV-501588 |
|
Line breaks and spacing are not showing up correctly in the Comment field of the Trip Report grid when viewed in Read-only/Review mode.
|
DEV-502878 |
|
In some cases, the Content field on a document appears blank when the document is approved.
|
DEV-504353 |
| Description |
Issue No. |
|
Vault fails to render protected Microsoft Word files.
|
DEV-428489 |
|
While "Allow download without overlays" is disabled, Vault gets stuck after failing to apply overlays when users attempt to download the rendition.
|
DEV-452942 |
|
Windows users cannot open controlled copy documents containing Japanese fonts.
|
DEV-453436 |
|
In rare cases, Vault fails to render Microsoft Word files.
|
DEV-454057 |
|
In some cases, Vault fails to render .TIFF files.
|
DEV-458844 |
|
Vault returns different MD5 checksum values on Merge Fields documents depending on the retrieval method.
|
DEV-459011 |
|
In some cases, Vault displays multiple file sizes for the same viewable rendition.
|
DEV-465637 |
|
After a user approves a manual rendition of a non-renderable source file, the manual rendition no longer appears in the Renditions list.
|
DEV-466681 |
|
In some cases, Vault displays an incorrect value for the Pages field on new document versions.
|
DEV-466968 |
|
In some cases, the Remove icon may be missing from the Upload New Version dialog box.
|
DEV-467381 |
|
Vault fails to display viewable renditions for documents created using the Make a Copy action.
|
DEV-467924 |
|
After performing the Merge Anchors action, Vault does not update merged references to remaining anchors.
|
DEV-468130 |
|
Vault displays an incorrect error message when users upload attachments larger than the maximum file size.
|
DEV-468197 |
|
After updating document fields via Vault Loader, Vault incorrectly clears lookup fields.
|
DEV-468717 |
|
In rare cases, Vault fails to create a controlled document template when multiple state changes occur in quick succession.
|
DEV-470337 |
|
In some cases, users cannot perform the Download Notes action on unsupported mime type documents.
|
DEV-471486 |
|
Vault returns incorrect MD5 checksum values after Merge Fields updates.
|
DEV-472149 |
|
A rendition profile called "Custom" is available for selection when the Rendition Profile field is a dependent field in a field dependency rule.
|
DEV-472582 |
|
In some cases, users are unable to move pending (or unsaved) arrow annotations after resizing the browser window.
|
DEV-472690 |
|
In some cases, tokens incorrectly appear on documents.
|
DEV-473831 |
|
Vault incorrectly allows users to delete references on read-only Approved Claim records.
|
DEV-474173 |
|
In some cases, Vault displays an incorrect number of attachments.
|
DEV-474531 |
|
After checking in a document edited in Google Drive, the document in Vault does not display the edits.
|
DEV-475943 |
|
In some cases, asset renditions are not copied over to the file system for newly approved versions.
|
DEV-476010 |
|
The browser may freeze after a user creates a link annotation on a document with over 400 Linked Document relationships.
|
DEV-477122 |
|
In some cases, after a user searches for and selects certain documents in the Library, the "Document Not Found" page displays.
|
DEV-479112 |
|
The Learn More link on the document upload page redirects to the wrong page.
|
DEV-480308 |
|
In some cases, fonts in viewable renditions appear differently than in the source document.
|
DEV-480905 |
|
Under certain conditions, users are unable to update Major Version Number document field using a VPK.
|
DEV-482151 |
|
Find in Document fails to return results if the first word in the search is a single character.
|
DEV-482344 |
|
In some cases, Vault removes source document relationships.
|
DEV-482854 |
|
Under certain conditions, attempts to reclassify documents result in a server error.
|
DEV-484203 |
|
If users use a doc field containing '#' as an auto name, the '#' is replaced with @veevaEscapeCharacter.
|
DEV-484207 |
|
In some cases, document updates take much longer than they should, especially in Vaults with a high number of document annotations.
|
DEV-485027 |
|
Field dependency components that begin with "dep" have a Modified Date field value, but audit logs show no changes.
|
DEV-485186 |
|
In some cases, users are unable to update document fields, receiving an Unexpected Error.
|
DEV-485302 |
|
After regenerating a trip report, the status for Prior Version may be incorrect in the report and other places where the value is used.
|
DEV-485548 |
|
When a Delete Minor Version Entry Action fails, users may observe unexpected errors or documents with an incorrect version.
|
DEV-485863 |
|
In some cases, users receive a "Server having problems" error when attempting to view a document within a nested binder.
|
DEV-485930 |
|
Running the Create Presentation action on the same document fails if the values of the Lifecycle Stage and Lifecycle State Stage ID fields have changed.
|
DEV-486213 |
|
In some cases, the Review & Approve Monitoring Event workflow generates Trip Reports documents without a viewable rendition.
|
DEV-486224 |
|
When classifying or reclassifying documents, lookup fields may not populate.
|
DEV-486772 |
|
When indexing a document, Vault may index the Website field incorrectly.
|
DEV-486882 |
|
After updating a document with previously populated inactive fields, Vault sets the fields to blank.
|
DEV-487193 |
|
In some cases, certain approval workflows that update a document field do not re-render merge fields.
|
DEV-487798 |
|
After bulk updating document fields, Vault incorrectly attributes the update to a user rather than the system on the audit trail.
|
DEV-488373 |
|
In some cases, some binders may become inaccessible due to corrupted data.
|
DEV-489695 |
|
In some cases, OCR renditions show "There was an error during document processing" until a user refreshes the page.
|
DEV-490188 |
|
If users use a doc field containing '#' as an auto name and the auto name exceeds its character limit, the '#' is replaced with @veevaEscapeCharacter.
|
DEV-490554 |
|
After document creation, OCR may update shared fields, which updates the Last Modified By field, even though the shared field values have not changed and there are no audit entries.
|
DEV-490720 |
|
In some cases, users receive internal server errors when attempting to upload documents.
|
DEV-493991 |
|
With Vault File Manager enabled, when uploading a file larger than 4 GB via Create Draft or Upload New Version, users may incorrectly be allowed to use the Create button.
|
DEV-495015 |
|
After inactivating a shared document field that contains multiple values, updating the document results in duplicate values on the inactive field.
|
DEV-495275 |
|
In some cases, font processing fails for Type 3 fonts that do not have a font name, and this may result in unexpected validation errors.
|
DEV-495579 |
|
With Vault File Manager disabled, attempting to upload a file larger than 4GB may result in Vault incorrectly displaying the load screen rather than displaying an error.
|
DEV-495825 |
|
At times, documents disappear from a binder, even when previously visible.
|
DEV-496169 |
|
In some cases, Vault File Manager fails to list documents in the Checked Out tab.
|
DEV-496759 |
|
When using Vault’s File Staging Server, after classification from staged to specific document type, a large size asset file may incorrectly remain in the inbox.
|
DEV-496954 |
|
When a user selects the Today option next to a document Date field, the Apply button remains disabled until the user manually selects the date from the calendar.
|
DEV-502066 |
| Description |
Issue No. |
|
After continuous publishing, when a source document is matched across multiple submissions, some source documents are missing from submission exports or the XML, and link navigation doesn't always work.
|
DEV-340560 |
|
In some cases, when a user includes a hyperlink's source and target documents in multiple in-progress submissions, publishing only updates one of the submissions.
|
DEV-350627 |
|
When a user inputs duplicate values into Content Plan fields with the “Values must be unique” configuration, the Content Plan hierarchy viewer does not display an error message.
|
DEV-380580 |
|
The RIM Submission Publishing job clears and re-populates Submission and Application document fields, which can intermittently prevent some users from accessing documents via Dynamic Access Control.
|
DEV-385330 |
|
In some cases, Vault falsely reports warnings when validating Rule 1153 in a grouped submission.
|
DEV-415503 |
|
In some cases, Vault does not remove open validation results after a Content Plan section is inactivated.
|
DEV-430359 |
|
Vault fails to report Rule 1306 when a Content Plan Item's Published Output Location contains multiple consecutive forward slashes ("/").
|
DEV-442686 |
|
In some cases, while using the RIM-PromoMats connection, Vault does not automatically trigger the RIM to PromoMats Compliance Package Outbound job.
|
DEV-442712 |
|
If the Content Plan contains an inactive and active Module 1, the Regional XML does not ignore the inactive status, resulting in an incorrect xlink:href value.
|
DEV-455599 |
|
The Report Level Content Plan publishing job intermittently fails to run concurrently with scheduled jobs.
|
DEV-456564 |
|
When a document matches both an active and inactive Content Plan Item, Vault changes the Published Output Location of the active Content Plan Item to the value of the inactive Content Plan Item after continuous publication.
|
DEV-457968 |
|
In some cases, Submission Administrative Information may not appear when two Module 1 sections have the same XML Element Name and the user inactivates one Module 1 section.
|
DEV-458211 |
|
In some cases, regional XML files fail to render as expected.
|
DEV-461062 |
|
In some cases, Vault fails to publish ZA Regional XML when Submission Type and Efficacy are excluded from Submission Administrative Information.
|
DEV-461385 |
|
When a source and target document are matched to multiple submissions and a user publishes the submissions at the same time, some source file paths stored in Vault may be incorrect.
|
DEV-461739 |
|
In some cases, Vault includes internal Vault error classes in external Vault Java SDK logs.
|
DEV-462474 |
|
When dispatching a Global Content Plan, Vault fails to copy Content Plan sections which contain tokens for a Pharmaceutical Form relationship object.
|
DEV-464830 |
|
When dispatching a Global Content Plan for a US Submission, Vault copies Switzerland-only Event Pharmaceutical Form records.
|
DEV-464953 |
|
When there is a large load of concurrent content plan creation, users may see a delay between the completion of the creation and viewing of the hierarchy in the content plan viewer.
|
DEV-465554 |
|
In some cases, the Create Content Plan job fails for previously-published Report Level Content Plans if the plan’s object type is changed.
|
DEV-467445 |
|
When the same document is matched to different Content Plan Items with different Product Variants, Vault fails to populate Active Dossier section 3.2.P with the matched documents for both Product Variants.
|
DEV-468854 |
|
Vault displays fewer records in the Global Content Plan creation notification than were created during the operation.
|
DEV-468995 |
|
When users create a Regulatory Objective or Submission within the Submission Wizard, the resulting record does not appear in the respective object record drop-down.
|
DEV-470251 |
|
Vault fails job run time and extract performance requirements when extracting Application relationships.
|
DEV-470561 |
|
In some cases, on-demand publishing of a single Content Plan Item in a given study triggers Vault to re-publish unchanged Content Plan Items in the same study.
|
DEV-472380 |
|
When attempting to run bulk submission archive export from a report, some submission information is not generated if the exportedSubmissionIds are null or empty.
|
DEV-472515 |
|
Under certain conditions, the "Submissions Bulk Export Confirmation" dialog does not allow a user to cancel.
|
DEV-474410 |
|
In some cases, the Submissions Archive Viewer icon appears even if the submission has not been published or archived.
|
DEV-475124 |
|
While using the Submission Wizard, Vault only pre-selects applicable records on the pages that the user explicitly visits.
|
DEV-475892 |
|
In some cases, a subsequent continuous publishing job run can overwrite previously-generated validation results of US rules 2002 and 2012 and EU rules 7.4 and 9.4.
|
DEV-476524 |
|
In some cases, the submission validation result shows US 1255 CDER and CBER as failed when the submission includes a Lot Distribution Report in XML format.
|
DEV-477532 |
|
After users update a Report Level Content Plan, created records do not inherit join field values from parent records.
|
DEV-477591 |
|
In some cases, Submissions Publishing is rejected due to XML being generated with lower case HA tags.
|
DEV-478429 |
|
After a user clicks Cancel on the Regulatory Objective change warning dialog, Vault incorrectly clears selections on records.
|
DEV-478847 |
|
When an Application folder name includes square brackets (“[“ or “]”), the related Index.xml does not render.
|
DEV-478932 |
|
When a user selects ‘Commit’ in the IDMP Viewer, the resulting dialog reads “click Commit to save changes” instead of “click Continue to save changes”.
|
DEV-479460 |
|
There is a minor typo in the IDMP record generation results: “The confidentiality indicator field must be populated on the registered rite [site] role record."
|
DEV-479467 |
|
The Manage Registered Details wizard fails to load when a selected Regulatory Objective Name is an integer.
|
DEV-479983 |
|
Vault does not export files with special characters correctly, resulting in inconsistencies between the contents in the ZIP file and the XML backbone and causing validation errors.
|
DEV-480887 |
|
Vault fails to automatically populate the Application and Submission fields when importing grouped submissions.
|
DEV-480917 |
|
Users in Vaults without a configured Content Plan or Content Plan Item object lifecycle encounter a server error when applying a Type filter in the Content Plan hierarchy viewer.
|
DEV-481343 |
|
The RIM Harmonization Job ends with errors encountered when a placeholder has an invalid xlink:href path.
|
DEV-481348 |
|
The RIM harmonization job does not correct the placeholders created for some grouped Submissions.
|
DEV-481499 |
|
The Extract Application Relationships job fails if the user who initiates the action does not have permission to Read matching Submission relationship object fields.
|
DEV-482506 |
|
Under certain cirumstances, continous publishing is able to clear a user's XML Modified File.
|
DEV-483771 |
|
When Active Dossiers are populated from a Submission Content Plan, sections may be duplicated or missing.
|
DEV-484399 |
|
Vault may inaccurately return Rule 1735 failures.
|
DEV-485533 |
|
Japan submissions fail PMDA validation if the xlink:href field is blank.
|
DEV-486057 |
|
When a target document for a link is updated and Continuous Publishing is set to No, the source document is not up-versioned and the link is broken.
|
DEV-486202 |
|
Users are unable to modify notification templates that include the ${gatewayFailure} token.
|
DEV-486223 |
|
Users are unable to make changes to unverified Registration join record lifecycle states.
|
DEV-486229 |
|
When pre-selecting Application relationship records in the Submission Wizard, Vault displays only 1,000 records (instead of 2,000).
|
DEV-487018 |
|
Vault does not include the Application folder within the zip file for AS2 transmissions to Health Canada.
|
DEV-487680 |
|
When navigating back to the SA viewer from a breadcrumb on a document's detail page, documents that should be visible are hidden under a section.
|
DEV-488647 |
|
In some cases, the Manage Registered Details wizard displays a generic error message in the validation results file.
|
DEV-488881 |
|
When users open links in the Content Plan Viewer grid in a new tab, the breadcrumb trail is not displayed on the object record details page.
|
DEV-489809 |
|
In some cases, Vault creates (instead of merges) duplicate study folders in the Submissions Archive Application view.
|
DEV-490603 |
|
Vault may inaccurately return F09 errors.
|
DEV-491818 |
|
Users receive runtime errors if they have submission join records under inactive applications.
|
DEV-492201 |
|
Concurrent batch updates on the same binder cause Publishing jobs to fail.
|
DEV-495136 |
|
In some cases, a current Japanese Submission fails to publish when a previous Japanese Submission does not have a regional leaf node in the index.xml.
|
DEV-495162 |
|
In some cases, when a user navigates to and from an Active Dossier object record detail page, Vault records each instance within the breadcrumb trail.
|
DEV-496022 |
|
When creating records in bulk, Vault incorrectly reports Application join records as not created in the results file when there are multiple matching records.
|
DEV-496042 |
|
The UDI Submission Viewer grid fails to properly display search results or filtering options if the included records contain empty field values.
|
DEV-496166 |
|
When updating a Global Content Plan, Vault creates duplicate Content Plan Item records if the related Content Plan Item Template record is set to Repeat Submission Groupings.
|
DEV-497074 |
|
When the Vault RIM UUID value is blank within a Provenance Controlled Vocabulary record, Vault displays an error and prevents the Generate IDMP Elements and Generate FHIR Message actions from running.
|
DEV-497197 |
|
Submission import fails for Applications tagged with Correspondence documents.
|
DEV-498926 |
|
In some cases, users without read access to the Submission object are unable to view Content Plans and Content Plan Items via the root Content Plan record tree layout.
|
DEV-500735 |
|
When updating registered details, Vault displays object field names instead of labels on the Edit & Verify page.
|
DEV-502472 |
|
The compliance_package_v and compliance_package_documents_v integration rules do not support query object relationships.
|
DEV-502656 |
|
Users are unable to add columns for the European Medical Agency (EMA) and European Directorate to the Active Dossier Viewer.
|
DEV-502832 |
| Description |
Issue No. |
|
Fixed issues with Inbox Item localization where Inbox Item fields did not appear in the language set on the Default Localization field of the user profile, the Inbox Item Product section header was only partially translated, and some Japanese labels had incorrect translations.
|
SAF-24972 & SAF-26322 & SAF-23925 |
|
Fixed an issue where, when an adverse event was reported in English, the exported E2B files incorrectly included the language in the data elements of section E.I Reaction(s) / Event(s).
|
SAF-25044 |
|
Fixed an issue where, when E2B files were imported to create AERs or Cases, all Combination Product records were created as Base Case Product object types, and the Product field on all records was populated based on the Combination Product Registration instead of the Constituent Product Registrations.
|
SAF-25697 |
|
Fixed an issue where the CIOMS I form reported only the primary adverse event outcome for Cases with multiple adverse events.
|
SAF-25864 |
Fixed an issue with Date Received by Manufacturer (Section G4) field mapping when generating FDA MedWatch 3500A forms. Now, the Case New Info Date field (if populated) will be used for the Date Received by Manufacturer on the form for both Initial and Follow-Up Cases. If the New Info Date field is blank, the field on the form will be populated as follows:
- For Initial Cases, the Initial Receipt Date field will be used.
- For Follow-Up Cases, the date will be left blank.
|
SAF-26026 |
|
Fixed an issue where Generic Product Names were excluded from CIOMS I forms.
|
SAF-26107 |
|
Fixed an issue where, when Study Content Protection was set to "Mask Unblinded Content", Dosage admin dates and duration were masked on E2B exports.
|
SAF-26482 |
|
Fixed an issue where, after selecting Verify on one or more Inbox Item sections, if the global Edit and then Cancel buttons were selected, the sections appeared to revert to an Unverified state, though refreshing the page updated the display to the Verified state again.
|
SAF-26728 |
|
Fixed an issue where, when data entry or translation to a non-English language was performed, dropdown fields appeared in English on some Case fields regardless of the setting on the Language field of the User Profile.
|
SAF-26841 & SAF-27096 & SAF-27097 |
|
Fixed an issue where, when creating a Follow-Up Case from a global Case using the Create Follow-Up Case user action, the Localized Follow-Up Case link was not populated on the localized narrative document.
|
SAF-26917 |
Fixed an issue where, when importing an E2B(R2) file, if the Suspect or Interacting products were not listed first, the following fields were not mapped to the Case Assessment correctly:
- B.4.k.13.1a Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)
- B.4.k.13.1b Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)
- B.4.k.13.2a Time Interval between Last Dose of Drug and Start of Reaction / Event (number)
- B.4.k.13.2b Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)
- B.4.k.17.1 Did Reaction Recur on Re-administration?
|
SAF-27458 |
|
Fixed an issue where, when an Inbox Item was promoted to a Follow-Up Case, custom fields were not copied from the previous Case version. If using the Create Follow-Up Case user action, custom fields were copied as expected.
|
SAF-27559 |
|
Fixed an issue where device fields were excluded from EMA E2B(R3) Submissions for Combination Products if the Constituent Product Type was not Drug.
|
SAF-27570 |
|
Fixed an issue with E2B import to AER where the system did not populate the MPID Version value from the file on the Case Product record, instead overwriting it with "-" or the active WHODrug dictionary version.
|
SAF-27607 |
|
Fixed an issue with global Case processing where, when trying to update the rank of a Product with a Substance to a Product without a Substance, an error appeared if the Product with a Substance was on a linked Localized Case.
|
SAF-27681 |
|
Fixed an issue where, when Cases were imported using migration user, the Imported Cases were not automatically indexed for duplicate case detection.
|
SAF-27780 |
|
Fixed an issue where, when an Adverse Event Report was created from a non-E2B source file with a date in the Receipt Date field, the date was not applied to the New Info Date field on the Inbox Item.
|
SAF-27863 |
|
Fixed an issue where, when creating a localized Follow-Up Case, the child and grandchild records were moved to the Closed state.
|
SAF-27870 & SAF-29170 |
|
Fixed an issue where, when promoting E2B-imported Inbox Items, incorrect values appeared in the Source Type field on Case Assessment Results.
|
SAF-27871 |
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Fixed an issue where, when the Evaluate Reporting Obligations action was run on a Case with a product registered in multiple countries, the exported E2B files incorrectly included the country-specific registration details entered on the Case Product for all countries instead of just the registration in the target jurisdiction.
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SAF-27877 |
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Fixed an issue where, when importing an E2B(R2) file that included multiple Adverse Events with the same MedDRA code, the Case Assessment records were not imported correctly.
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SAF-27954 |
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Fixed an issue where an incorrect error message was displayed when creating a Follow-Up Case if there was an existing invalid Follow-Up Case for that Case.
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SAF-27978 |
Fixed an issue with generating E2B(R3) files where the system was missing the following field validations:
- C.2.r.2.1 Reporter’s Organisation field may not exceed 60 characters.
- C.5.1.r.1 Study Registration Number must be populated, and must conform to the format YYYY-######-##, for example 2022-123456-78.
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SAF-28032 & SAF-28218 |
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Fixed an issue where Transmission dates were incorrect on PADER Non-Primary Suspect Drug Reports.
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SAF-28049 |
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Fixed an issue where adding more than ten Dosage records to a Case Product was prevented by the system.
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SAF-28074 |
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Fixed an issue where, when a Case was locked, the system prevented SDK jobs from updating the Case and its child records.
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SAF-28203 |
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Fixed an issue where a term in the Vault Safety Designated Medical Events (DME) Watchlist did not match the EMA DME. The term Immune thrombocytopenia (10083842)* was added.
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SAF-28217 |
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Fixed an issue where, when using EMA E2B(R3) as the base document type for a custom E2B format, the Patient RoA TermID Version and Parent RoA TermID Version E2B data elements were set to version 2.2, instead of 2.1.
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SAF-28256 |
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Fixed an issue where Medical History & Concurrent Conditions records were compared during duplicate detection, though they should not be.
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SAF-28297 |
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Fixed an issue where Case Contacts assigned Rank 1 were always compared as Reporter-type Case Contacts during duplicate detection, even when the "Contact is also Reporter" checkbox was not selected.
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SAF-28328 |
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Fixed an issue where, when a Case Test Result (Text) field had more than 18 characters, all subsequent field characters were replaced with zeroes on CIOMS I and FDA 3500A forms.
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SAF-28354 |
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Fixed an issue where, when the Evaluate Regulatory Conformance action was run, the system determined where the Case was reportable and which validations to run based on the Product or Study Registration countries. As a result, regional validation rules may have caused unnecessary validation failures on the Case.
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SAF-28392 |
Fixed an issue where the Age and Weight fields were not populated on the CIOMS I form after report generation if the following setup was present on the Case:
- Age (normalized) was blank
- Weight (normalized) was blank
Now, if the Age (normalized) or Weight (normalized) fields are blank, the Age or Weight value and unit (if present) are exported and set on the CIOMS I form.
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SAF-28482 |
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Fixed an issue with promoting an Inbox Item to multiple Cases where, if the Patient Initials field was set to Reason Omitted, the system overrode the value with “PLACEHOLDER”.
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SAF-28523 |
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Fixed an issue where, when the “AE in Jurisdiction” rule parameter on a rule set was set to No, Vault Safety did not apply the Agency Rule.
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SAF-28534 |
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Fixed an issue where E2B(R3) Transmissions were not generated when the Blind Protection Relatedness Override - CIOMS I and E2B feature was enabled. This issue affected all E2B(R3) transmissions.
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SAF-28536 |
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Fixed an issue where Localized Substance records were not generated for Study Cases.
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SAF-28573 |
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Fixed an issue where, on the NMPA Report Source Controlled Vocabulary type, editing the Name field was prevented by the system.
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SAF-28619 |
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Fixed an issue where Product Registrations were not populated on Combination Products after Case promotion.
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SAF-28665 |
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Fixed an issue where the Weight field was not populated on FDA MedWatch 3500A forms after report generation if only Weight (normalized) was present. Now, if the Weight value and unit are blank on the Case, the Weight (normalized) field (if present) will be exported and set as the Weight on the FDA 3500A form.
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SAF-28687 |
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Fixed an issue where, when an Inbox Item did not have a Product assigned Rank 1 (primary), it could not be promoted to a Follow-Up Case or merged to an In-Flight Case.
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SAF-28722 |
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Fixed an issue where, when creating an Inbox Item, if a mixture of precise dates (for example, YYYY/MM/DD) and partial dates (for example, YYYY) was used for specific field combinations, and those dates included the same year, the system prevented Inbox Item creation.
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SAF-28723 |
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Fixed an issue where, when importing an E2B(R3) file, if the Date of Birth was a partial date (for example, YYYY), the Date of Birth field was blank on the Inbox Item.
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SAF-28779 |
Fixed an issue with migrated Cases where the country was not populated on CIOMS I or FDA 3500A forms after report generation. Now, the fields will be populated as follows:
- CIOMS I: The 1a. Country field is mapped from one of the following Case fields, ordered by priority: primary Adverse Event Country, primary Reporter Country, non-primary Reporter Country.
- FDA 3500A: The E.1. Name and Address > Country field is mapped from the Case primary Reporter Country.
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SAF-28781 |
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Fixed an issue with migrated Cases where if either the Normal Low Value or Normal High Value fields were blank on the Case, the normal range for the test was not populated on CIOMS I or FDA 3500A forms after report generation. Now, if one field is blank, the missing part of the range is populated as "Unknown". If neither the Normal Low Value nor the Normal High Value is populated on the Case, the normal range for the test is not included on generated reports.
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SAF-28782 |
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Fixed an issue where, on CIOMS I reports in the 14. Suspect Drug(s) field and FDA 3500A reports in the C1.1 Name and Strength and D1 Brand Name fields, the Product (Coded) field was populated when the Product (Reported) field was expected. Now, when the Product (Reported) field is populated, it will be exported by default. To change the default export to the Product (Coded) field, contact Support.
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SAF-28783 |
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Fixed an issue with imported Cases where the Case Assessment Record ID was exported to the Assessment Name field on CIOMS I forms. Now, the field will be populated with the Case Adverse Event Name and Product Name.
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SAF-28784 |
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Fixed an issue where open-label products were masked on blinded forms.
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SAF-28785 |
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Fixed an issue where, when there was a non-conditional Lifecycle Event Action that triggered a State change, the system prevented Inbox Item creation.
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SAF-28807 |
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Fixed an issue where, when the Create Revision or Create Follow-Up action was selected for a Case containing a custom child record without a lifecycle state, a non-descriptive error message appeared.
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SAF-28809 |
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Fixed an issue where the Expectedness auto-calculation was not the same on linked Global and Foreign Localized Cases.
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SAF-28835 |
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Fixed an issue where expectedness was not evaluated correctly when cross reporting to a study for the same product.
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SAF-28890 |
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Fixed an issue with validating E2B(R3) files where the D.9.2.R.2 Reported Cause(s) of Death (free text) was required if D.9.2.R.1 Reported Cause(s) of Death was populated. Now, in accordance with EMA Business Rules, the field is always optional.
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SAF-28917 |
Fixed the following issues with global (ICH) Validation Criteria:
- Changes to editable fields were prevented by the system.
- An incorrect error message appeared when a user tried to edit protected fields.
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SAF-28919 & SAF-29580 |
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Fixed an issue where, when the Sender's Organisation field included more than 60 characters, a system error prevented the Evaluate Reporting Obligations action from running for PMDA E2B(R3) reports.
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SAF-28951 |
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Fixed an issue where, when promoting an Inbox Item with Localization to a Follow-Up Case, the narrative document was not attached to the global Follow-Up Case.
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SAF-28956 |
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Fixed an issue where, when a Localized Case was linked to a global Case, the system prevented editing the Product and deleting Substance records on the global Case.
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SAF-28957 |
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Fixed an issue where, when an Inbox Item was created from a non-E2B source file, the Origin field was blank after Case promotion.
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SAF-28973 |
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Fixed an issue where Validation Results could not be processed and saved.
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SAF-28979 |
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Fixed an issue where, when on the Potential Matches page if a user selected a Case for which they did not have Read permission in the left pane and then selected Create a New Case, the system displayed an error message. Then, after the action was cancelled, the Inbox Item was promoted to a new Case.
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SAF-29000 |
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Fixed an issue where, when a Case was missing a UID, the List of Subjects Who Died During the Reporting Period was not generated, preventing DSUR report creation.
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SAF-29033 |
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Fixed an issue where the most conservative product selection was not limited to products defined within the Product Parameter.
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SAF-29045 |
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Fixed an issue with E2B import to Inbox Item where a Product on the Drug History record was created as a Case Product when there was a Product in the library with the same name.
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SAF-29125 |
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Fixed an issue where, when a Case Test Result value and unit were blank, the system prepended a zero to Case Test Result (Text) fields on CIOMS I and FDA 3500A forms.
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SAF-29165 |
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Fixed an issue where, although the Inbox Item included the Patient Date of Birth and Product Dosage First Admin Date, the Age at Vaccination was not auto-calculated on the Case after promotion.
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SAF-29210 |
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Fixed an issue where, when the Deep Duplicate Search feature was enabled, the system excluded Preferred Terms (PT) when comparing the Event (MedDRA) field during duplicate case detection. The system compared using only Lowest Level Terms (LLT), which may have resulted in missing potential matches.
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SAF-29296 |
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Fixed an issue with CIOMS I generation by displaying the earliest onset date for the 4-6 Reaction Onset field instead of the onset date for the primary Adverse Event.
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SAF-29299 |
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Fixed an issue where, after importing an Inbox Item from a non-E2B source document, if you manually changed the New Info Date on the Inbox Item, the Receipt Date was being populated incorrectly upon Case promotion.
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SAF-29301 |
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Fixed an issue where, when importing an E2B file through a System Gateway, the system did not create Inbox Items, and instead created AERs.
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SAF-29432 |
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Fixed an issue where, when a new PADER report was generated, previous versions of the report changed to the "Generating" state.
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SAF-29529 |
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Fixed an issue where, if an E2B file included Parental Medical History or Parental Drug History details but did not include Parent Case information, the system prevented both importing the file as an Imported Case and promoting the imported Inbox Item to a Case. Now, upon initiating either action, the system creates the Parent Case for the associated child records.
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SAF-29588 |
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Fixed an issue with EMA Submissions where the Transmission Lifecycle reverted to the "MDN Received" state after the "ACK Accepted", "ACK Rejected", or "ACK Warning" state.
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SAF-29634 & SAF-30876 |
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Fixed an issue where, when merging an Inbox Item to a Follow-Up Case, Assessment Tags were not correct on the Case name, though they were correct on the Case.
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SAF-29723 |
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Fixed an issue where, if a manual Inbox Item was saved and then edited to add a Source document, the Save button had to be selected twice to save the Inbox Item.
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SAF-29772 |
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Fixed an issue where, when the Case Assessment Expectedness was blank on a Study Case, the system did not correctly evaluate the most conservative product and assessment.
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SAF-29911 |
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Fixed an issue where the Event (Reported) - English field for the primary Adverse Event record was not being compared in duplicate detection.
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SAF-29913 |
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Fixed an issue where, if a previous Transmission to a destination was Downgraded, the system did not correctly evaluate the One Last Time Reporting Rule.
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SAF-29919 |
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Fixed an issue where the Investigational New Drug (IND) registration number was not populated on FDA MedWatch 3500A files when the Product Registration was not linked to a Study Product. Now, for Study Cases, the IND data element (G.5) is populated from the Study Registration Number field on the associated US Study Registration.
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SAF-29949 & SAF-31756 |
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Fixed an issue where, when importing an E2B(R2) file, the system created a Parental Case when no parent information was present.
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SAF-29967 |
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Fixed an issue with generating FDA MedWatch 3500A forms for imported Cases where, if the Name field on the Organization record was changed from "FDA" to "US FDA", "Foreign" was selected in the Report Source field (G.3) on the form even when the Case Primary Reporter Country was set to USA.
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SAF-29968 |
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Fixed an issue where, if custom Case Assessment fields were not configured on the Case Compare Page Layout, those were reset to blank after promoting an Inbox Item to a Follow-Up Case.
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SAF-30122 & SAF-31154 |
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Fixed an issue where the localized narrative document was not always generated for Domestic Cases.
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SAF-30151 |
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Fixed an issue with imported Cases where, if the Case included any partial dates (for example, YYYY) that were not populated in both the normalized and text Date fields, the system prevented the creation of a Follow-Up Case from the Case Compare page.
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SAF-30185 |
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Fixed an issue where Expectedness was not auto-calculated after changing seriousness criteria on Case adverse events.
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SAF-30226 |
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Fixed an issue where, when an Inbox Item was created manually and then merged to an in-flight Case, an additional Narrative document was created on the updated Case.
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SAF-30227 |
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Fixed an issue where, when evaluating expectedness during cross reporting for Investigational to Marketing or Marketing to Marketing scenarios, Study Core Datasheets were considered incorrectly. This resulted in unnecessary Submissions being generated.
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SAF-30237 |
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Fixed an issue where, when Reaction Recurrence was blank, the Doesn't Apply checkbox was not selected in the C.10. Event Reappeared After Reintroduction? field on FDA 3500A forms after report generation.
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SAF-30245 |
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Fixed an issue where, when generating FDA E2B(R2) reports, the XML header was populated with "http" instead of "https" for the Document Type Definition (DTD).
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SAF-30388 |
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Fixed an issue where, when the Re-evaluate Submission/Distribution action was run on a Case, a NullPointerException (NPE) error appeared if a Case Assessment record was not linked to an adverse event.
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SAF-30478 |
Fixed an issue with generating EMA E2B(R3) files where the system was missing the following field validations:
- For submissions to EVCTM, medicinal products classified as suspect or interacting (G.k.1 = 1,3) should have at least one EU Method of Assessment (G.k.9.i.2.r.2.EU.1) for each event or reaction reported in the ICSR.
- EU Result of Assessment (G.k.9.i.2.r.3.EU.1) is required if the EU Method of Assessment (G.k.9.i.2.r.2.EU.1) value is "1".
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SAF-30485 |
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Fixed an issue where, when more than 2,000 characters were entered in the Product Dosage Text field on a global or localized Case, the system would display either an incomplete or no error message, and did not save the record.
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SAF-30520 & SAF-30325 |
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Fixed an issue where Follow-Up Rule questionnaire emails were not sent for a Case if any related Correspondence record did not include a Correspondence Document.
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SAF-30769 |
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Fixed an issue where, when an imported Inbox Item included a Product Dose value without a unit, the system prevented the Promote to Case action but did not display an error message.
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SAF-30799 |
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Fixed an issue with E2B import to Inbox Item where the Age of Parent (normalized) value was not auto-calculated after Case promotion.
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SAF-30873 |
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Fixed an issue where the Age of Parent was exported on EMA E2B(R3) files when there was no normalized value.
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SAF-30874 |
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Fixed an issue where, when a Case included an Adverse Event with no value in the Primary field, the Interval Line Listing was not generated, preventing DSUR report creation.
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SAF-30883 |
Fixed an issue where, when custom values were entered in the Patient RoA and Parent RoA fields, the following issues occurred in the B.4.k.8 Route of Administration and B.4.k.9 Parent Route of Administration data elements on E2B(R2) exports:
- On ICH E2B(R2) files, the data elements were missing.
- On HC E2B(R2) files, code "065" for Unknown was exported, incorrectly.
Now, for custom routes of administration, code "050" for Custom is exported.
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SAF-30950 |
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Fixed an issue where, if Case Assessments for the non-primary product were deleted from a Case, the system prevented the creation of a Follow-Up Case.
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SAF-30963 |
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Fixed an issue where missing Clinical Trial Application (CTA) numbers in the Study Name data element (A.2.3.1) caused submissions to Health Canada to be rejected.
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SAF-31025 |
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Fixed an issue with E2B import to Inbox Item where, when the B.1.7.1d Continuing and B.1.10.7.1d Continuing data elements were populated with "3", the system incorrectly mapped them to "Not Asked" instead of "Unknown".
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SAF-31373 |
Fixed an issue with E2B import to Inbox Item where, if multiple MedDRA codes were included as comma separated values in the B.5.3b Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code) data element, no Diagnosis Records were created on Case promotion. Now, the Case Diagnosis record is populated as follows:
- When a single eight-digit code is imported, the MedDRA term and code are populated in the Name (MedDRA) field.
- When multiple codes are imported, they are populated as text in the Name (Reported) field.
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SAF-31472 |
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Fixed an issue where, when a Transmission email included an attachment, the Email Transmission state did not change to Sent or Completed.
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SAF-31707 |