The issues listed below may impact Vault functionality for some users. We are actively investigating all known issues and will be providing fixes and updated information in future Vault releases.
| Description |
Issue No. |
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When an IE user has not signed in for an hour or more and attempts to upload a Google Drive file to a placeholder document, Vault fails to authenticate.
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DEV-449129 |
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When IE users perform Google Drive actions that should prompt for sign-in, Vault fails to prompt them.
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DEV-449259 |
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Vault fails to populate metadata for PDF/A renditions while metadata population is enabled.
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DEV-451606 |
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While "Allow download without overlays" is disabled, Vault gets stuck after failing to apply overlays when users attempt to download the rendition.
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DEV-452942 |
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In some cases, Vault generates XFA forms with missing pages.
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DEV-464500 |
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In some cases, the Remove icon may be missing from the Upload New Version dialog box.
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DEV-467381 |
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In some cases, applying overlays takes longer than expected.
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DEV-467536 |
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The .ZIP file downloaded from Cart is sometimes empty.
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DEV-467849 |
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In some cases, Vault fails to render .MP4 files.
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DEV-470622 |
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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.
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DEV-475716 |
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In some cases, Vault does not automatically assign DAC roles when users classify documents.
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DEV-477131 |
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The Learn More link on the document upload page redirects to the wrong page.
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DEV-480308 |
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In some cases, Vault fails to complete Formatted Output jobs.
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DEV-481780 |
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In some cases, users cannot download Formatted Outputs of audit records.
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DEV-482292 |
| Description |
Issue No. |
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In some cases, when attempting to view a page to which they do not have access, users may receive an internal error message instead of an access denied error message.
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DEV-454196 |
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In some cases, clicking on the the document panel after initiating a document workflow hides the side panel.
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DEV-457329 |
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Drag and drop upload fails when attempting to to create a draft.
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DEV-466981 |
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In some cases, when opening the application or submission record details page from the Submissions Archive Viewer, the Back to Previous Page breadcrumb is not displayed on the object record details page.
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DEV-469574 |
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In some cases, after creating a single object record, Vault fails to display the breadcrumb trail.
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DEV-473094 |
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When adding a new new user to sharing settings, the sharing settings UI does not update until the page is manually refreshed.
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DEV-474763 |
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In some cases, loading Record Detail Views for Monitoring Events takes longer than expected.
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DEV-474928 |
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The Learn More link on the Scheduled Data Export Settings page redirects to the wrong page.
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DEV-475524 |
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The Undo Acceptance action is unavailable on the Tasks page.
|
DEV-478821 |
| Description |
Issue No. |
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When changing the Person assigned on the External Collaborator field of the CAR record, the previous Person record is not inactivated; two Person records are active.
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DEV-462259 |
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When an error message appears during a Material Verification Checklist configuration, the word "Error" displays in non-English error messages.
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DEV-469663 |
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Vault fails to analyze a COA file when there is an unexpected date format.
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DEV-470030 |
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When hovering over a Why? item in a 5 Whys Diagram, the hovercard text is not readable.
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DEV-473088 |
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When running the Update Training Assignments job to create a Training Assignment for a new Learner, the Training Dashboard does not populate the new hours for the new Training Assignment and new Learner.
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DEV-476258 |
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When hovering over the Upload button in an External Training Requirement record, the tool tip displays in the middle of the record section.
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DEV-477298 |
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For users with no Read permission on the MV Response-Hazard object, Vault does not load questions in the Checklist sections.
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DEV-477737 |
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When running the Control Chart for more than 500 Inspection Sample Test Result (ISTR) records, the chart displays the latest 500 ISTR records incorrectly.
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DEV-480734 |
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An unexpected error message displays in the CSV result file when trying to upload a CSV question file in the Introduction section of a Quiz.
|
DEV-481733 |
| Description |
Issue No. |
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While using the RIM-PromoMats connection, Vault may fail to create Crosslinks due to insufficient access.
|
DEV-442674 |
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In some cases, while using the RIM-PromoMats connection, Vault does not automatically trigger the RIM to PromoMats Compliance Package Outbound job.
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DEV-442712 |
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In some cases, Vault incorrectly enables Continuous Publishing when the submission contains an active User Exception Message.
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DEV-443529 |
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In some cases, Vault reports an unexpected SDK error when creating a Submission via the Create Related Records wizard.
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DEV-450960 |
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When displaying a Global Content Plan from an Activity, Vault fails to apply the Activity filter.
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DEV-456807 |
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During Submission deep/hierarchical copy, Vault fails to copy Submission Language when the source Submission Language record references a join object of the same parent object.
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DEV-459554 |
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In some cases, Vault includes internal Vault error classes in external Vault Java SDK logs.
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DEV-462474 |
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When Content Plan records fail to create during Global Content Plan dispatch, the dispatch summary file incorrectly reports them as successes.
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DEV-464165 |
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When a user splits a Content Plan Item, the resulting audit trail indicates the event as system-generated.
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DEV-464416 |
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When dispatching a Global Content Plan, Vault fails to copy Content Plan sections which contain tokens for a Pharmaceutical Form relationship object.
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DEV-464830 |
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When dispatching a Global Content Plan for a US Submission, Vault copies Switzerland-only Event Pharmaceutical Form records.
|
DEV-464953 |
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Vault falsely errors when updating Global Content Plans from an Event.
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DEV-465574 |
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In some cases, Vault performance is degraded when importing larger Submissions.
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DEV-468023 |
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Vault displays fewer records in the Global Content Plan creation notification than were created during the operation.
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DEV-468995 |
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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.
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DEV-470251 |
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Vault fails job run time and extract performance requirements when extracting Application relationships.
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DEV-470561 |
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Vault includes unsolicited “Record saved with no changes” audit trail entries for some Content Plan actions, including Split Content Plan Item.
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DEV-472624 |
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In some cases, the Submissions Archive Viewer icon appears even if the submission has not been published or archived.
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DEV-475124 |
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While using the Submission Wizard, Vault only pre-selects applicable records on the pages that the user explicitly visits.
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DEV-475892 |
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After users update a Report Level Content Plan, created records do not inherit join field values from parent records.
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DEV-477591 |
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After a user clicks Cancel on the Regulatory Objective change warning dialog, Vault incorrectly clears selections on records.
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DEV-478847 |
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In some cases, users are unable to save edits made to gateway profiles.
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DEV-478947 |
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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”.
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DEV-479460 |
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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."
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DEV-479467 |
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The Extract Application Relationships job fails if the user who initiates the action does not have permission to Read matching Submission relationship object fields.
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DEV-482506 |
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While using the Submission Wizard, Vault only pre-selects applicable records on the pages that the user explicitly visits.
|
DEV-482549 |
| Description |
Issue No. |
|
When a Global Case has no Localization specified but includes a product that is registered in another country where the Case is also reportable, after Case Approval the narrative document is missing on the Localized Case.
|
SAF-25583 |
When creating an Inbox Item, if the Organization field is hidden from the page layout, the following errors occur:
- The Organization field is not automatically populated as expected
- Company Products and Studies do not appear in the dropdown fields
Due to these errors, Inbox Item creation is prevented.
|
SAF-26418 |
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When performing data entry or translation to a non-English language, regardless of the setting on the Language field of the User Profile, dropdown fields appear in English.
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SAF-26841 & SAF-27096 & SAF-27097 |
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When enabled, the Deep Duplicate Search feature causes a slower than expected performance during duplicate detection and Case promotion.
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SAF-26883 & SAF-28182 |
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When creating a Follow-Up Case from a global Case using the Create Follow-Up Case user action, the Localized Follow-Up Case link is not populated on the localized Narrative document. If a Follow-Up Case is created from an Inbox Item, links are populated as expected.
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SAF-26917 |
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When processing a Domestic Case with a custom dose and the Localization field set to Japanese (Japan), data elements G.k.4.r.1 and G.k.4.r.8 are excluded from PMDA E2B(R3) files.
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SAF-27081 |
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On a global Case, when trying to update the rank of a Product with a Substance to a Product without a Substance, an error appears if the Product with a Substance is on a linked Localized Case.
|
SAF-27681 |
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When Cases are imported using migration user, the Imported Cases are not automatically indexed for duplicate case detection.
|
SAF-27780 |
For Inbox Items imported from an E2B file, the system calculates a negative normalized age and displays an error message in the following scenarios:
- Patient date of birth is later than the adverse event onset date
- Patient date of birth is later than the receipt date
- Adverse event onset date is later than the cessation date
When this occurs, the system prevents Case promotion.
|
SAF-27792 |
When you create an Adverse Event Report from a non-E2B source file with a date in the Receipt Date field, the date is not applied to the New Info Date field on the Inbox Item.
Workaround: Manually add the date to the New Info Date field.
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SAF-27863 |
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When you run the Evaluate Reporting Obligations action on a Case with a product registered in multiple countries, the exported E2B files incorrectly include 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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When importing an E2B(R2) file that includes multiple Adverse Events with the same MedDRA code, the Case Assessment records are not imported correctly. For example, this situation can occur when the E2B file contains multiple adverse events sharing the same reaction MedDRA code but different verbatim terms.
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SAF-27954 |
When a Local Datasheet inheriting terms from a Core Datasheet is set to Enable Precise Expectedness and a value is set for Unexpected Seriousness Criteria on both the Core and Local datasheets, then the Case Assessment Expectedness is generated using the Core Datasheet instead of the Local Datasheet.
Workaround: There are two ways to update the Case Expectedness field. For more information, see Override Case Expectedness or Listedness.
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SAF-27961 |
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When generating Distributions for Combination Product Constituents, the Reporting Family Product is not used as the most conservative product.
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SAF-27998 |
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Adding more than ten Dosage records to a Case Product is prevented by the system.
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SAF-28074 |
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When a Case is locked, the system prevents SDK jobs from updating the Case and its child records.
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SAF-28203 |
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When an FDA submission includes combination products with device constituents, the product section in the E2B(R2) file includes extraneous blocks for non-device constituents, in addition to the required blocks for the drug and device combinations.
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SAF-28216 |
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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 are set to version 2.2, instead of 2.1.
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SAF-28256 |
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When running Evaluate Regulatory Conformance, the system determines where the Case is reportable and which validations to run based on the Product or Study Registration countries. As a result, regional validation rules may cause unnecessary validation failures on the Case.
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SAF-28392 |
For imported Inbox Items, expanding and then collapsing the Case Contact section causes a blank page to appear.
Workaround: Refresh the page. The Inbox Item appears as expected.
|
SAF-28465 |
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For an Inbox Item, if the Patient Initials field is set to a Reason Omitted, when the Promote to Mutiple Cases action is used the system overwrites the value with “PLACEHOLDER” during promotion.
|
SAF-28523 |
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When the “AE in Jurisdiction” rule parameter on a rule set is set to No, Vault Safety does not apply the Agency Rule. When the rule parameter is set to Yes, the Agency Rule is applied correctly.
|
SAF-28534 |
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On the NMPA Report Source Controlled Vocabulary type, editing the Name field is prevented by the system.
|
SAF-28619 |
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After promoting a Case with a Combination Product that has Product Registrations, the Product Registrations are not populated.
|
SAF-28665 |
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When creating an Inbox Item, if a mixture of precise dates (for example, YYYY/MM/DD) and partial dates (for example, YYYY) is used for specific field combinations, and those dates include the same year, the system prevents Inbox Item creation.
|
SAF-28723 |
When importing an E2B(R3) file, if the Date of Birth is a partial date (for example, YYYY), the Date of Birth field is blank on the Inbox Item.
Workaround: Use the Calendar pop-up tool to select a date or enter the date manually.
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SAF-28779 |
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When enabled, the Deep Duplicate Search feature causes the system to exclude Preferred Terms (PT) when comparing the Event (MedDRA) field during duplicate case detection. The system compares using only Lowest Level Terms (LLT), which may result in missing potential matches.
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SAF-29296 |
When an Inbox Item contains Case Identifiers with leading or trailing spaces (for example, “NN-ABCD-123 ”), during promotion to a Follow-Up Case, on the Case Compare page the system cannot match the Case Identifier to the record on the original Case. When Create Follow-Up is selected, an error message appears and the system prevents Follow-Up Case creation.
Workaround: On the Case Compare page, manually match the Case Identifier on the Inbox Item to the Case before selecting Create Follow-Up.
|
SAF-31206 |