| Description |
Issue No. |
|
Running the Send Document Package action can result in slow load times when large numbers of users have access to the selected documents.
|
DEV-471877 |
|
TMF documents that use a custom name format do not transfer correctly.
|
DEV-488070* |
|
Users may encounter a server error when attempting to access the Study Site page if the Site Document Exchange section is configured on the Study Site page or if the user attempting to access the Study Site page does not have Read permission for the Distribution Task.
|
DEV-509554* |
|
For some Studies, the Actual Values for Metrics Over Time are not correctly updated at the Study and Study Country levels.
|
DEV-511054 |
|
Users are unable to create milestones using the Apply Milestone to Template user action when there is a large number of template milestones to be created/applied.
|
DEV-512059 |
|
In some cases, users are unable to transfer Studies and Sites from ClinOps to RIM Vaults using the RIM-Clinical connector.
|
DEV-516145 |
|
Budget creation may fail when the name field is system-managed.
|
DEV-516925 |
|
When running the Generate Subsequent CTN action and selecting the Dev Termination type, users receive a server error.
|
DEV-517098* |
|
In some cases, Vault does not create/update payable items correctly when the payable item's lifecycle state is changed to Inactive.
|
DEV-518575* |
|
When users update a payable event date to match a different Fee Schedule, Vault does not update the existing payable item and instead creates two new payable item records.
|
DEV-518891* |
|
In some cases, Milestone Dates roll up to a Study even when Previous Milestones are not populated.
|
DEV-518903* |
|
When deleting a Subject record in CDMS for a connected Study, the Subject status is not correctly updated to "Deleted in CDMS" in the Clinical Vault.
|
DEV-518917* |
|
Vault does not correctly update the LRST in the connection page when Enable Study Level Last Successful Run is not enabled.
|
DEV-518985* |
|
When Enable Restricted Data Transfer is enabled, running the Refresh Study Connected Data action results in an error.
|
DEV-519710* |
|
In certain cases, Vault displays "Server Having Problems" when running the Review Outcome action on Monitoring Events.
|
DEV-520133 |
|
In some cases, document transfer fails without generating user exception messages.
|
DEV-520714 |
|
Vault allows users to remove the Connection Value from a Study object despite a connection being in place and continues to transfer the Study object even after removing the Connection Value.
|
DEV-521881* |
| Description |
Issue No. |
|
In rare cases, users with delegated access are able to edit the user profile of the account they are accessing.
|
DEV-506098* |
|
In rare cases, cross-domain users may be unable to view the My Vaults header.
|
DEV-508338 |
|
In some cases, Layout Rules do not apply correctly after saving a record.
|
DEV-513663 |
|
In some cases, if a controlled section comes before its controlling section in a checklist design, the Export Checklist Design action fails with no results.
|
DEV-515620 |
|
Matrix reports visualized as a control chart plot two separate data points instead of one.
|
DEV-516231* |
|
In rare cases, a user's membership status may be inconsistent between what is displayed on the Vault Users page and the Domain Users page.
|
DEV-516545 |
|
After editing and then deleting an ad hoc checklist question, the next section fails to load.
|
DEV-517243* |
|
The Start Checklist action does not populate the Ad Hoc Sections Allowed field value from the checklist design.
|
DEV-519396* |
|
Users may experience performance issues on pages with many object controls.
|
DEV-520953* |
|
Users may experience performance issues when accessing the record action menu and action bar.
|
DEV-521493 |
|
In cases involving certain VQL queries, users may experience slow performance.
|
DEV-521587* |
|
Users may see very high page counts when attempting to print certain pages.
|
DEV-521963 |
|
In some cases, Vault runs redundant queries on records, which may cause performance issues for users.
|
DEV-522122* |
| Description |
Issue No. |
|
Vault may add incorrect system audit history entries upon an Admin changing entry criteria or event action configurations on an object lifecycle.
|
DEV-513760 |
|
In some cases, in the Process Navigator's Documents section, filter drop-down menus may not correctly display filtering options.
|
DEV-514410* |
|
Vault may display an error when executing a Sibling Check Related Record State Change action which targets a Yes/No field on a high volume object.
|
DEV-514525* |
|
The Cancel Training Assignments job may display with its API name instead of its label.
|
DEV-515356 |
|
In some cases, users receive an error when attempting to remove documents from a DCC.
|
DEV-516117 |
|
Vault may display an error when a user attempts to remove a document from a Document Change Control, if a prior document version that is still linked to the DCC is missing the required "Document Link Category" field.
|
DEV-516451 |
|
Vault fails to return an error when creating quality record checks via MDL for the Quality Event: Complaints object type in a Vault with the standalone Complaints object enabled.
|
DEV-517781* |
|
Vault Validation Management may incorrectly display a server error when a user attempts to save a test step without filling in any values.
|
DEV-518178* |
|
Vault displays an error when an Admin attempts to make Test Step fields read-only via atomic security in the Completed (completed_state__v) lifecycle state.
|
DEV-518223* |
|
In some cases in Vault Validation Management, Vault may display the test execution page instead of the test review page after a user performs the Review Test action.
|
DEV-518227* |
|
In some cases, assets served from e-learning courses are not cached which can cause some courses to appear choppy or load slowly.
|
DEV-518581 |
|
When submitting XML to the health authority's gateway with Vault Product Surveillance, Vault may receive an ACK3 Rejected response with a "Health Effect Clinical Code is missing or invalid" message.
|
DEV-523503* |
| Description |
Issue No. |
|
When generating or exporting FHIR messages, the Lifecycle State column is missing a filter selection for undefined/blank values.
|
DEV-438190* |
|
The compliance_package_v and compliance_package_documents_v integration rules do not support query object relationships.
|
DEV-496887* |
|
Continuous publishing does not publish permalinks to Approved matched documents which were previously marked as not Ready for Publishing.
|
DEV-499306* |
|
Vault displays documents and the empty submission folder structure in Submissions Archive Viewer, even if all documents are merged.
|
DEV-507706* |
|
Users may experience performance issues when executing Set Leaf Operation on an EDL item whose corresponding application has a large sequence of submissions.
|
DEV-510599 |
|
Vault incorrectly reports US Rule 1500 as passed when a Content Plan Item’s Title contains a line break.
|
DEV-511403 |
|
In some cases, users may experience false positive validation failures on Submissions.
|
DEV-511442 |
|
In some cases, Vault incorrectly reports Rule 1734 as failed due to a missing ts.xpt file.
|
DEV-511924 |
|
In some cases, Content Plan record Names are vertically misaligned in the Content Plan Viewer.
|
DEV-512472* |
|
In some cases, users encounter errors during bulk record creation when the Regulatory Objective field within the Activity object is required.
|
DEV-513709* |
|
In some cases, Vault publishes documents with an uppercase file extension (e.g., testfile.XPT), resulting in Rule 1255 failure.
|
DEV-514032 |
|
When Rule 1306 fails, error detail messages do not include the invalid path.
|
DEV-514197* |
|
When a document with an uppercase file extension (e.g., testFile.XPT) and submission’s Published Output Location is set to include a lowercase file extension, Vault publishes the document with the uppercase extension, resulting in Rule 1255 failure.
|
DEV-514886 |
|
Vault incorrectly reports Rules 1306 and 1323 as passed when a Content Plan Item’s Published Output Location (xml_xlinkhref__v) begins with “/”.
|
DEV-514929 |
|
Vault incorrectly reports Rule 1737 as failed during continuous publishing when a published Content Plan Item’s Title (xml_title__v) is updated.
|
DEV-515205* |
|
Vault incorrectly reports Rule 1737 as failed during continuous publishing when a published Content Plan Item’s Published Output Location (xml_xlinkhref__v) is updated.
|
DEV-515210* |
|
In some cases, Vault cannot publish and merge Report Level Content Plans if the related Publishing Element Page Numbering field is set to “Overall Page Number”.
|
DEV-515523 |
|
Vault incorrectly reports US Rule 7 as passed when Form 1571 is missing.
|
DEV-515616 |
|
Vault incorrectly reports Rule F07 as failed when a Content Plan’s m1 section is not the first child in the tree.
|
DEV-515973 |
|
In some cases, applications with a lot of submissions take a long time to validate XMLs.
|
DEV-516105 |
|
In some cases, Vault incorrectly reports US Rule 1119 as passed when the STF DTD is missing.
|
DEV-516507 |
|
In some cases, Vault does not clear previous validation results for EU Rule 11.10 during publishing.
|
DEV-516651 |
|
The Submission Archive Viewer's migration jobs incorrectly skip inactive submissions.
|
DEV-516863* |
|
When a document is matched to two or more Content Plan Items, Vault inconsistently reports validation results.
|
DEV-516983* |
|
When the Enable Application Relationships setting is enabled, Vault does not copy custom fields from Event relationship records to Application and Submission relationship records.
|
DEV-517843* |
|
In some cases, Vault does not activate Application Inactive Ingredient records when dispatching global content plans.
|
DEV-517906* |
|
Vault incorrectly reports validation results for EUDAMED rules BR-UDID-113a and BR-UDID-113b.
|
DEV-518481* |
|
The Application Packaging object is missing the Shelf Life field.
|
DEV-519202 |
|
Vault incorrectly reports Rule C06 as passed when an item’s Published Output Location begins with a space (e.g., “ m1-leaf.pdf”).
|
DEV-520112 |
|
In some cases, during bulk publishing, overlays may show incorrect values in some fields.
|
DEV-520367 |
|
In some cases, users are unable to execute the Calculate Status Workflow action on Regulatory Objective records if the prefix doesn't start with the previously hardcoded value.
|
DEV-521661 |
|
In rare cases, Vault may experience a server error when a user attempts to create a new regulatory objective.
|
DEV-522169* |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on October 25, 2022.
The Safety release, including all Platform fixed issues, is targeted for tentative availability on October 20, 2022.
| Description |
Issue No. |
|
Fixed an issue with E2B-import where the Inbox Item Source Data pane displayed the Dose Unit (Code) in the Dose Unit (Text) row, in addition to the Dose Unit (Code) row.
|
SAF-24412 |
|
Fixed an issue with narrative import APIs where, when the localized narrative was English, import was prevented.
|
SAF-30172 |
|
Fixed an issue with EMA E2B(R3) exports where some Unit of Measure values were exported using ICH codes although EMA codes existed.
|
SAF-30326 |
|
Fixed an issue where system performance was slow during Case promotion.
|
SAF-30764 |
|
Fixed an issue where, when creating a Study Indication record, saving was prevented but no error message was displayed. Now, an error message is displayed when the Study Indication does not exist in the MedDRA dictionary version used by the Study.
|
SAF-30974 |
|
Fixed an issue where a server error appeared when more than one MedDRA dictionary was configured in the vault and prevented users from initiating certain actions. Now, the system prevents users from creating multiple dictionaries of the same type.
|
SAF-31604 |
|
Fixed an issue where, when Localization was set on an Inbox Item, the English fields for Indication, Dose Form, Patient ROA, and Event were left blank.
|
SAF-31739 |
|
Fixed an issue with Localized Case Assessments where they were not generated using the Local Datasheet for the country in the Localization field.
|
SAF-31850 |
|
Fixed an issue where system performance was slow when creating Follow-Up Cases.
|
SAF-32041 & SAF-33670 |
|
Fixed an issue with the CSV rendition of imported E2B(R2) files where the B.4.k.18.1b Reaction(s) / Event(s) Assessed data element was populated with system-generated IDs, instead of the Adverse Event name.
|
SAF-32272 |
|
Fixed an issue where, when manually generating Transmissions, distributions did not go into the the Validation Error state even when Validation Status was set to Fail or Hard Fail.
|
SAF-32666 |
|
Fixed an issue where, when importing an E2B file to Inbox Item, a calculated value for B.1.2.3 (Patient age group) was displayed on the Inbox Item even though there was no existing value in the source file.
|
SAF-32723 |
|
Fixed an issue where, when importing an EMA E2B(R3), the GB country code did not default to "United Kingdom (Great Britain)" as expected for E.i.9 (Identification of the Country Where the Reaction / Event Occurred). In addition, the XI country code was unable to be imported.
|
SAF-32724 |
|
Fixed an issue with system performance when creating a Follow-Up Case from an Inbox Item or an Open Case.
|
SAF-32756 |
|
Fixed an issue with non-English MedDRA coding on Localized Cases where, after selecting a MedDRA-coded term for Case Product Indication, the value was not populated in the field.
|
SAF-32842 |
|
Fixed an issue where system performance was slow when creating localized Follow Up Cases.
|
SAF-33054 |
|
Fixed an issue with E2B-imported Inbox Items where Case promotion failed if the primary Case Contact did not have a qualification value.
|
SAF-33075 |
|
Fixed an issue where, in some instances, Case Dosage section fields became read only.
|
SAF-33184 |
|
Fixed an issue where, when errors occurred during initial and Follow-Up Case creation, system error messages did not describe the cause of the issue.
|
SAF-33196 |
|
Fixed an issue with E2B-import where, when a Study Case included a Product with a Drug Role of Concomitant, Follow-Up Case creation failed because the system set the Primary field to No.
|
SAF-33283 |
|
Fixed an issue where, when generating FDA MedWatch 3500A forms for Study Cases with Combination Products, the G5. Combination Product checkbox was not selected.
|
SAF-33313 |
|
Fixed an issue where the cross reporting rules engine was not correctly evaluating most conservative product outside of the general reporting jurisdiction.
|
SAF-33319 |
|
Fixed an issue with PMDA E2B(R3) exports where the G.k.4.r.6a Duration of Drug Administration (number) and G.k.4.r.8 Dosage Text data elements were exported for unrelated PMDA Reporting Categories.
|
SAF-33320 |
|
Fixed an issue where, when promoting an Inbox Item to a Case, the audit trail did not record the result from the Potential Matches page for any actions other than marking the Inbox Item as a Duplicate.
|
SAF-33339 |
|
Fixed an issue with MedDRA coding on Domestic Cases where, when using a non-English MedDRA browser, the value in the Reported field was replaced with the selected MedDRA-coded term.
|
SAF-33450 |
Fixed an issue with Workflows that prevented expanding a Follow-Up Case Workflow Timeline and assigning tasks to users.
Enablement: Support
|
SAF-33453 |
|
Fixed an issue with Inbox Items received from the Intake API where selecting the suggested date in any Date field did not populate the field.
|
SAF-33489 |
|
Fixed an issue where, when manually creating an Inbox Item, if the New Info Date and Report Type fields were populated before the Organization field, a system error occurred, preventing Inbox Item creation.
|
SAF-33518 |
|
Fixed an issue with E2B-import where, when a CSV rendition was generated rows appeared for B.4.k.18.2 Source Type, B.4.k.18.3 Method of Assessment, B.4.k.18.4 Assessment Result although they were not in the imported file.
|
SAF-33531 |
|
Fixed an issue where, when promoting an E2B-imported Inbox Item with a Combination Product to a Domestic Case, a system error occurred and the Domestic Case was not created if a Constituent Product included a Substance.
|
SAF-33589 |
|
Fixed an issue where, after successful email delivery of a Transmission, the Email Transmission State did not update from "Ready" to "Completed".
|
SAF-33590 |
|
Fixed an issue where running the Evaluate Regulatory Obligations action caused system issues.
|
SAF-33622 |
|
Fixed an issue where, when a large number of users loaded pages at once, system issues occurred.
|
SAF-33623 & SAF-33631 |
|
Fixed an issue where editing units of measurement caused system issues.
|
SAF-33653 |
|
Fixed an issue where system performance was slow when exporting E2B reports.
|
SAF-33661 |
|
Fixed an issue where system performance was slow when loading Narrative previews.
|
SAF-33669 |
|
Fixed an issue where case promotion failed when attempting to create a Follow-Up Case from an E2B-imported Inbox Item containing a case assessment linking a product with an empty adverse event.
|
SAF-33700 |
|
Fixed an issue causing performance issues when loading a Case.
|
SAF-33737 |
|
Fixed an issue where system performance was slow when running the Evaluate Regulatory Obligations action on a Case with a large number of cross reporting scenarios.
|
SAF-33749 |
|
Fixed an issue where, when a Case Transmission Profile was blank, during the Void Case user action the system displayed an error message and did not generate Transmission records for all previously submitted destinations.
|
SAF-33774 |
|
Fixed an issue causing performance issues when loading Case details.
|
SAF-33778 |
|
Fixed an issue with E2B(R2) import where, if B.4.k.2.1 (Medicinal Product Name as Reported by the Primary Source) was blank and B.4.k.2.2 (Substance / Specified Substance Name)included more than 250 characters across all Substance names, the import failed. Now, if B.4.k.2.1 is blank, the system maps the first Substance in B.4.k.2.2, based on alphabetical order, to the Product (Reported) field on the Case Product object.
|
SAF-33802 |
|
Fixed an issue where, when a Localized Case did not have a Transmission, the system prevented Transmission generation for the associated global Follow-Up Case.
|
SAF-33831 |
|
Fixed an issue with the Receive E2B API endpoint where the response returned a status of 400 (failure) when the request was accepted but certain issues occurred or the E2B import was still in progress.
|
SAF-33911 |
|
Fixed an issue where generating Transmissions caused system issues.
|
SAF-34025 |
|
Fixed an issue where running SDK jobs caused system issues.
|
SAF-34033 |
|
Fixed an issue where running the Evaluate Regulatory Obligations action caused system issues.
|
SAF-34116 |
|
Fixed an issue where, when running the Evaluate Regulatory Obligations action for FDA Cross Reporting, validations failed when the most conservative Case Product was blank.
|
SAF-34124 |
| Description |
Issue No. |
|
In some cases, field values containing special characters may not display properly.
|
DEV-502938* |
|
In some cases, users receive a "These search results were truncated because there were too many matches" message when it does not apply.
|
DEV-506389 |
|
In some cases, when trying to configure a Custom Tab, the Lifecycle State filter does not have any values as options in the dropdown despite applicable values existing.
|
DEV-511505 |
|
In some cases, users are unable to edit some fields inline despite having access to edit them.
|
DEV-513429 |
|
In some cases, users may experience unexpected behavior when searching for text.
|
DEV-513500* |
|
Users cannot use a search term to filter the values of a passthrough join object property in the advanced search dialog on documents.
|
DEV-514778 |
|
When performing an Object Text Similarity request, the system may fail to recognize synonyms from imported thesaurus files.
|
DEV-516241* |
|
Text Similarity Records requests fail to take related object filters into account.
|
DEV-517753* |
|
In some cases, users are able to begin inline editing read-only fields and then receive an error.
|
DEV-518919* |
|
When using Enhanced Suggest Links, stemming does not work when searching for phrases.
|
DEV-519029* |
|
In some cases, picklist values appear out of order and only the matched values of a multi-valued picklist are displayed.
|
DEV-519566* |
|
When users add an HVO lookup field to a list view's columns, Vault may hide all of the records in the list view.
|
DEV-519922* |
|
In some cases, Admins are unable to save their changes to views.
|
DEV-521222 |
|
In some cases, users are unable to select a case in Advanced Search.
|
DEV-521879 |
The Veeva Claims release, including all Platform fixed issues, is targeted for tentative availability on October 25, 2022.