| Description |
Issue No. |
|
In some cases, distribution tasks may fail with a "Version Already Defined for Document" error.
|
DEV-495103 |
|
When updating the related document field on quality issues referencing deleted documents, users receive a "server having problems" error.
|
DEV-501545 |
|
In some cases, running an Update and Return document action results in the incorrect version of the document being returned to the Clinical Operations Vault.
|
DEV-502120* |
|
In some cases, a Subject deleted in the CDMS Vault is not correctly deleted in the Clinical Operations Vault, though the visits for the Subject are correctly deleted in the Clinical Operations Vault.
|
DEV-503860* |
|
In very rare cases, Vault calculates payment request amounts incorrectly.
|
DEV-505141 |
|
When sending to RIM, the connection does not create major versions if the previous version is Superseded and restricted through QOR.
|
DEV-505321* |
|
In some cases, Sites cannot send documents to connected Clinical Operations Vaults.
|
DEV-508278* |
|
In some cases, Vault displays an error when attempting to send an agreement using the Clinicial Operations to CDMS Vault Connection.
|
DEV-508286* |
|
After running the Generate Payment Request action, users are unable to download or review the resulting file.
|
DEV-508408* |
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Users cannot create a new Study Person record from a Study Site when the Study Site is archived.
|
DEV-508600* |
|
In some cases, Vault fails to create Document Checks for documents transferred via Site Connect.
|
DEV-508801 |
|
In cases with both Simple and Complex rulesets, Vault displays "Cannot contact initiating Vault" when attempting to accept a TMF Transfer agreement.
|
DEV-509617* |
|
When generating a CTN Document, the Remarks field is cut off in the document if it includes more than 250 characters.
|
DEV-509784 |
|
In some cases, the Agreement wizard generates an error when users try to accept a new agreement.
|
DEV-510443* |
|
If an email address in the list of recipients is longer than 50 characters, the entire safety distribution fails.
|
DEV-510991* |
|
Users without permission to the Reference Site field on the site__v object are unable to create Site records.
|
DEV-511441 |
|
When training TMF Bot, CSV validation fails for CSVs that contain newlines in any of the entries.
|
DEV-511483 |
|
Crosslinks are included in document processing batches which slows down processing and may cause users to receive errors.
|
DEV-515131 |
|
Users are unable to use the Create Subsequent CTN action to copy the remarks field on CTN Combination Product field.
|
DEV-515761* |
| Description |
Issue No. |
|
When using the Send As Link To External Users feature, Vault does not allow email addresses to exceed 50 characters.
|
DEV-473592* |
|
In some cases when the server is under heavy load, PDF validation may incorrectly fail.
|
DEV-491570 |
|
In rare cases, Vault incorrectly renders characters within XML files.
|
DEV-495317 |
|
In some cases, permalink destinations change when Vault upversions a document.
|
DEV-501583 |
|
In some cases, Vault fails to navigate to the document inbox when multiple unclassified documents are uploaded by the Google Drive integration.
|
DEV-504016* |
|
Documents successfully converted to PDF/A may display errors in the Adobe Preflight tool.
|
DEV-504313* |
|
When the EDL batch matching job is configured to exclude inactive document types and unmatches documents with these types, the Match Documents user action will still match these documents.
|
DEV-505727* |
|
In rare cases, a server error may be encountered when a user creates document drafts.
|
DEV-506788 |
|
In some cases, Vault fails to display an empty translation of a label in non-English languages.
|
DEV-507849* |
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In some cases, Vault generates non-compliant PDF/A documents when the source document contains transparent objects.
|
DEV-509116* |
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Under certain conditions, Vault fails to show the option to create from template when creating relating documents on an object.
|
DEV-509305* |
|
In some cases, detecting duplicates in the document inbox results in documents that the user does not have access to.
|
DEV-510852 |
|
In some cases, a bulk action on all documents in a binder will yield a server error.
|
DEV-513076 |
|
Some document user actions are translated incorrectly in Spanish.
|
DEV-514447 |
| Description |
Issue No. |
|
Vault may fail to report F4 and G12 validation errors.
|
DEV-443861 |
|
When importing submissions, Vault creates documents in the Published (instead of Final) state.
|
DEV-475941 |
|
When a user adds columns to the Submissions Archive Viewer, only the Name and Submission columns are preserved if the page is refreshed.
|
DEV-485765* |
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When one document is matched to different Content Plan Items and the Published Output Location (POL) is updated during publishing, Vault reverts the POL to its previous value.
|
DEV-490910 |
|
When transferring from QMS to RIM, richtext fields are being processed as regular text and are being truncated.
|
DEV-496284 |
|
Users are unable to search with special characters in the Content Plan Viewer.
|
DEV-499082* |
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When the same document is matched to multiple Content Plan Items, but the Published Output Location is different, and the Source for Published Document is different, one of the documents is not published.
|
DEV-505504* |
|
In some cases, annotations to permalinks in source documents are not updated during publishing if the target document’s Source of Published Document is updated.
|
DEV-505604* |
|
Vault fails to create Submission Validation Result records for EU 9.4 or US 2002 and 2012 on regional EDL items while continuous publishing is set to No.
|
DEV-505888* |
|
In some cases, XML renditions of submissions fail when unicode characters are included in the application's folder name.
|
DEV-507788* |
|
In some cases, Vault incorrectly executes Rules 1735 and 1736 when Rule 1734 fails, and incorrectly reports Rule 1737 as failed when a submission includes duplicate datasets with different names.
|
DEV-508064 |
|
Breadcrumbs do not display when viewing Global Content Plans and Report Level Content Plans in Business Admin.
|
DEV-509072* |
|
In some cases, users encounter a server error when running an Impact Assessment Report from Reports.
|
DEV-509148* |
|
When saving a Content Plan View, Vault inconsistently displays some UI elements.
|
DEV-509187* |
|
In some cases, references are not published in the correct order.
|
DEV-509418 |
|
In some cases, users cannot complete a Submissions Archive Bulk Export.
Internal fix published in error
|
DEV-509482 |
|
In some cases, Compliance Packages are set to Submitted even while some crosslinks are not created in RIM due to a UEM, which will cause these documents to never be transferred.
|
DEV-509919 |
|
In cases where users have custom lookup/formula fields configured on both an application and a submission/ro join with the same field name, they are unable to edit or create new submission/ro joins.
|
DEV-510026 |
|
In some cases, users are unable to save data on the Edit and Verify page when there is a non editable dependent field.
|
DEV-510153 |
|
When a Submission join record fails to copy, Vault includes duplicate rows in the downloaded CSV.
|
DEV-510378* |
|
Users encounter a server error when updating custom matched formula fields on Submission relationship records.
|
DEV-510643* |
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Users are unable to reorder matched documents correctly when all the matched documents have blank order values.
|
DEV-510935* |
|
Lookup/formula custom matching fields are extracted as part of extracted application relationships. When this occurs, the user receives an error if they try to load application joins using the extracted ones with custom matching fields populated.
|
DEV-510970* |
|
When attempting to transmit a submission, users may incorrectly receive a "Number of Published files doesn't match" message.
|
DEV-511542 |
|
In cases where a user uploads a bad util file, all future STF XMLs fail to render.
|
DEV-511937 |
|
Users are unable to transfer documents from PM to RIM that have doc types containing an "Applications" field.
|
DEV-512283 |
|
In some cases, US Rule 1697 may report a false positive.
|
DEV-512393 |
|
Vault does not deep copy records if a source Submission or Regulatory Objective relationship record has values populated for the Application Source and custom matching fields.
|
DEV-512482* |
|
When creating Submission and Regulatory Objective relationship records without an Application Source, Vault allows users to populate custom matching field values.
|
DEV-512500* |
|
Users may receive server errors when attempting to edit the Organization object record without specifying the Gateway Profile field value.
|
DEV-512809 |
|
In some cases, regional leaf may have a placeholder checksum value in index.xml instead of the correct value.
|
DEV-513315* |
|
When a document is matched to two or more Content Plan Items, Vault intermittently sets mismatching checksum values during publishing and validation.
|
DEV-514771* |
|
Bulk updating tokens on Content Plan Sections using the Update Tokens in Field action does not work correctly.
|
DEV-514966 |
|
Vault resolves all values in a multi-value matched document token instead of only the first token.
|
DEV-515181* |
|
Health Canada submissions containing file paths longer than 100 characters are rejected.
|
DEV-515540 |
The RegulatoryOne release, including all Platform fixed issues, is targeted for tentative availability on October 4, 2022.
The Safety release, including all Platform fixed issues, is targeted for tentative availability on September 29, 2022.
| Description |
Issue No. |
|
Fixed an issue where system performance was slow during the Submit to Gateway action.
|
SAF-30075 |
|
Fixed an issue where certain E2B transmission ACKs were being treated as warnings instead of errors.
|
SAF-30513 |
|
Fixed an issue where, when generating PMDA E2B(R3) reports, Result Unit (Text) data was not exported to the F.r.3.4 Result Unstructured Data (free text) data element.
|
SAF-30629 |
|
Fixed an issue where, when an E2B(R2) report was retransmitted with attachments and an ACK 2 was received, the value in the Destination Case ID field on the Submission record was removed.
|
SAF-30781 |
Fixed an issue where some units of measure in the Unified Code of Units of Measure (UCUM) dictionary were not supported on E2B(R2) export. Now, values are exported in E2B(R2) files, with overflow support for some data element limits as follows:- If the B.4.k.5.1 (Dose Value) and B.4.k.5.2 (Dose Unit) values exceed data element character limits, additional text is included in the B.4.k.6 (Dosage Text) data element, preceded by the label "DOSAGE:".
- If the B.4.k.5.6 (Cumulative Dose Value) and B.4.k.5.7 (Cumulative Dose Unit) values exceed data element character limits, additional text is included in the B.4.k.19 (Additional Information on Drug) data element, preceded by the label "CUMULATIVE DOSAGE:".
Where these values are populated, they are exported to a limit of 2,000 characters.
|
SAF-31085 |
|
This release includes the following update to the Promote to Multiple Cases action. When the Inbox Item does not include reporter, patient, or adverse event information, placeholder information is no longer applied to the primary Reporter-Type Case Contact, Patient, or primary Adverse Event records. Instead, all fields on these Case records are blank.
|
SAF-31105 |
|
Fixed an issue where, when promoting an Inbox Item to a Follow-Up Case, if the original Case had duplicate Case Assessments for an adverse event and product pair a system error occurred. Now, the system prevents the creation of more than one Case Assessment for an adverse event and product pair.
|
SAF-31182 |
|
Fixed an issue with E2B(R3) export logic for Domestic Cases, which resulted in the Localized Narrative being included in the H.1 (Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information) data element, as well as the H.5.r.1a (Case Summary and Reporter's Comments Text) data element. Now, the Localized Narrative is exported only to the H.5.r.1a data element.
|
SAF-31689 |
|
Fixed an issue with FDA MedWatch 3500A generation where the G6. If IND/PreANDA, Give Protocol # field was populated although the G5. IND # field was blank.
|
SAF-31701 |
|
Fixed an issue where, when an Evaluate Regulatory Conformance action was run at the same time that an ICSR preview document was being generated from the Case, then the case validations failed to run.
|
SAF-31710 |
Fixed an issue with which values populate the B.3.2 (Results of tests and procedures relevant to the investigation of the patient) data element on E2B(R2) export. Now, the B.3.2 data element is mapped from the following Case Test Result fields:- Test Name (LLT)
- If Test Name (LLT) is blank, the Test Name (Reported) field is mapped instead.
- Test Date
- Result (Code)
- Result (Text)
- Comments
Where these values are populated, they are exported to a limit of 2,000 characters.
|
SAF-31935 |
Fixed an issue where, when a Vault included large Watchlists and Datasheet libraries, system performance was slow during the following tasks:- Creating or editing a Case Adverse Event
- Manually creating a Case Assessment
|
SAF-31968 & SAF-31993 |
|
Fixed an issue where the SUSAR tagging logic did not consider certain situations, such as postmarket studies or clinical trials, which resulted in incorrect Case Assessment tagging.
|
SAF-32056 |
|
Fixed an issue where, when promoting an Inbox Item to a Case, the system did not snapshot the Patient RoA TermID and TermID Version to the first Case Product Dosage record for Combination Products.
|
SAF-32059 |
|
Fixed an issue where, for E2B(R2) exports, Vault Safety used the TermID and Version from the Case Product Dosage object (case_product_dosage__v) for the B.4.k.8 “Route of administration” tag in the E2B(R2) export file. In some cases, this led to an incorrect value being sent for this field. Now, the TermID code from the Route of Administration (route_of_administration__v) object populates the B.4.k.8 data element.
|
SAF-32087 |
|
Fixed an issue where, when generating HC E2B(R2) files for a Submission with a linked Localized Case, the system always exported the data from the Global Case, regardless of the Localization Scope setting.
|
SAF-32135 |
|
Fixed an issue where system performance was slow when the Re-evaluate Reporting Obligations action was run.
|
SAF-32139 |
|
Fixed an issue where, when viewing an Inbox Item imported from an E2B file prior to the 22R2 Vault Safety release, a system error occurred and the Inbox Item was not displayed.
|
SAF-32234 |
|
Fixed an issue where system performance was slow when manually creating a Domestic Case Product record.
|
SAF-32240 |
|
Fixed an issue where, when creating an AER from an E2B(R2) file, Test Name (LLT) values were not imported to the Case Test Results section.
|
SAF-32310 |
|
Fixed an issue with Localized Cases where the Case Product Indication (Reported) field was cleared after saving a MedDRA-coded term.
|
SAF-32314 |
|
Fixed an issue where, when generating E2B(R3) reports, if the Retransmit field was set to No, the C.1.6.1.r.1 Documents Held by Sender data element was not populated with the text from the Attachment Description and Attachment Description Continued fields from Case documents of the Case > Source > Attachment type.
|
SAF-32428 |
|
Fixed an issue where users could send Vault POST API Profile requests without using a certificate.
|
SAF-32455 |
|
Fixed an issue where, when an update was made to an Email Cover Letter Template that was referenced on multiple Email Profiles, when the Re-evaluate Reporting Obligations action was run, some Transmission documents failed to generate.
|
SAF-32490 |
|
Fixed an issue where, when the Evaluate Reporting Obligations was run on a Study Case that included a non-Study product, the system incorrectly evaluated the non-Study product as the most conservative product when generating Distributions.
|
SAF-32492 |
|
Fixed an issue where, after promoting an Inbox Item with a Combination Product to a Case, Product Registrations for Product Constituents were not snapshotted to the Case.
|
SAF-32523 |
|
Fixed an issue with FDA MedWatch 3500A generation where, when Study Content Protection was set to "Mask Unblinded Content" and Patient Content Protection was set to "E2B Mask", Investigational New Drug (IND) registration numbers from Study Registrations were not blinded.
|
SAF-32719 |
|
Fixed an issue where, when the Validation Criteria for ICH.D.2.1-1 was set to Always Evaluate, the system incorrectly validated imprecise dates that were missing the day.
|
SAF-32821 |
|
Fixed an issue where, when generating an FDA 3500A report for a Study Case, if the Study Registration Number was blank the report was not generated.
|
SAF-32847 |
|
Fixed an issue where, when generating Transmissions, the system did not accept the Local Expedited Criteria reporting rule when it was set to "Same as Previous".
|
SAF-32878 |
Fixed an issue where, when strict case locking was enabled, the following actions did not complete on unlocked Cases and the system did not provide an error message:- Evaluate Regulatory Conformance
- Evaluate Reporting Obligations
- Assign Due Date
- Submit to Gateway
|
SAF-32889 |
|
Fixed an issue with Case Promotion where, when copying patient information from an existing Case into a new Case, a system error occurred if Suspect/Interacting Products were selected to be copied.
|
SAF-32924 |
|
Fixed an issue on Case Product Indication where selecting "Clear" on an auto-coded MedDRA term would not remove the term.
|
SAF-32932 |
|
Fixed an issue with Case Type-based localization where, when the "Domestic Case Processing and Submission: Report Type-Based Localization" feature was enabled, the system did not consider a Localization's Case Type setting when generating foreign Localized Cases for Submissions.
|
SAF-32940 |
Fixed an issue where Vault Safety did not include the following AER-tagged EDQM Routes of Administration terms:- ROA-20085000
- ROA-20082000
- ROA-20083000
Vault Administrators must add the mappings for these EDQM terms. Mapping is managed through Business Admin > EDQM Mappings.
|
SAF-32986 |
|
Fixed an issue where, when the Localization field was set to Global, after Case promotion the value in the Case Product Indication (Reported) field was missing on the Case.
|
SAF-33006 |
|
Fixed an issue where, when generating an FDA E2B(R2) report for a Study Case with a Combination Study Product, < drug > blocks were not exported.
|
SAF-33104 |
|
Fixed an issue where, when Cross Reporting Most Conservative Submission was enabled, system performance was slow when the Evaluate Reporting Obligations action was run on a Case.
|
SAF-33122 |
|
Fixed an issue where, when the Reporter Country was edited on an Inbox Item, the Localization field was not updated. This resulted in the incorrect Localization being applied to the Case after promotion.
|
SAF-33146 |
|
Fixed an issue where, when an Inbox Item for a Domestic Postmarket Case included a Combination Product, a Localized Case was not generated after Case promotion.
|
SAF-33148 |
|
Fixed an issue where, when a Combination Product was added to a Study Case, the Product Type for Device constituents was "Study Product", instead of "Device", and the Product Name did not appear correctly.
|
SAF-33154 |
|
Fixed an issue where system performance was slow when auto-coding and saving MedDRA terms.
|
SAF-33215 & SAF-33237 |
|
Fixed an issue where blinded studies were not supported for the standalone CIOMS II line listing report. Additionally, if an administrator has configured Study Product placeholder names for a blinded Study, the CIOMS II report will now populate the placeholder name instead of the generic "Blinded" label.
|
SAF-34978 |
The Veeva Claims release, including all Platform fixed issues, is targeted for tentative availability on October 4, 2022.