Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
The following fixes are introduced in 22R2. For details about fixed issues in the Vault Platform in 22R2, see the Vault Release Notes.
Intake
| Category | Description | Issue Number |
|---|---|---|
| Case Promotion | 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 |
| Case Promotion | Fixed an issue where, when promoting E2B-imported Inbox Items, incorrect values appeared in the Source Type field on Case Assessment Results. | SAF-27871 |
| Case Promotion | 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”. | SAF-28523 |
| Case Promotion | Fixed an issue where Product Registrations were not populated on Combination Products after Case promotion. | SAF-28665 |
| Case Promotion | 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. | SAF-29000 |
| Case Promotion | 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. | SAF-29210 |
| Case Promotion | 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. | SAF-28722 |
| Data Entry | 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 |
| Data Entry | 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. | SAF-28723 |
| Data Entry | Fixed an issue where, when there was a non-conditional Lifecycle Event Action that triggered a State change, the system prevented Inbox Item creation. | SAF-28807 |
| Document Intake | 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 |
| Document Intake | Fixed an issue where, when an Inbox Item was created from a non-E2B source file, the Origin field was blank after Case promotion. | SAF-28973 |
| Document Intake | 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. | SAF-29301 |
| Duplicate Detection | Fixed an issue where, when Cases were imported using migration user, the Imported Cases were not automatically indexed for duplicate case detection. | SAF-27780 |
| Duplicate Detection | 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. | SAF-29296 |
| Duplicate Detection | Fixed an issue where the Event (Reported) - English field for the primary Adverse Event record was not being compared in duplicate detection. | SAF-29913 |
| Duplicate Detection | Fixed an issue where Medical History & Concurrent Conditions records were compared during duplicate detection, though they should not be. | SAF-28297 |
| E2B Import | 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 |
| E2B Import | 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. | SAF-27954 |
| E2B Import | 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. | SAF-28779 |
| E2B Import | 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. | SAF-29125 |
| E2B Import | Fixed an issue where, when importing an E2B file through a System Gateway, the system did not create Inbox Items, and instead created AERs. | SAF-29432 |
| E2B Import | Fixed an issue where, when importing an E2B(R2) file, the system created a Parental Case when no parent information was present. | SAF-29967 |
| E2B Import | 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. | SAF-29588 |
| E2B Import | 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:
|
SAF-27458 |
| E2B Import | 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 |
| E2B Import | 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. | SAF-28328 |
| E2B Import | Fixed an issue with E2B import to Inbox Item where the Age of Parent (normalized) value was not auto-calculated after Case promotion. | SAF-30873 |
| E2B Import | 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. | SAF-30799 |
| E2B Import | 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". | SAF-31373 |
| E2B Import | 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:
|
SAF-31472 |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Auto-Expectedness | Fixed an issue where Expectedness was not auto-calculated after changing seriousness criteria on Case adverse events. | SAF-30226 |
| Auto-Expectedness | Fixed an issue where the Expectedness auto-calculation was not the same on linked Global and Foreign Localized Cases. | SAF-28835 |
| Blind Protection | Fixed an issue where open-label products were masked on blinded forms. | SAF-28785 |
| Data Entry | 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 |
| Data Entry | Fixed an issue where adding more than ten Dosage records to a Case Product was prevented by the system. | SAF-28074 |
| Data Entry | Fixed an issue where, when a Case was locked, the system prevented SDK jobs from updating the Case and its child records. | SAF-28203 |
| Data Entry | 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. | SAF-28957 |
| Data Entry | 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. | SAF-30520,
SAF-30325 |
| E2B Export | 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. | SAF-28951 |
| Follow-Ups | 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. | SAF-28809 |
| Follow-Ups | 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. | SAF-29723 |
| Follow-Ups | 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. | SAF-30185 |
| Follow-Ups | 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. | SAF-30963 |
| Follow-Ups | 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. | SAF-30122,
SAF-31154 |
| Follow-Ups | 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 |
| Follow-Ups | 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. | SAF-27978 |
| Localization | 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 |
| Localization | Fixed an issue where Localized Substance records were not generated for Study Cases. | SAF-28573 |
| Narratives | 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. | SAF-28956 |
| Narratives | Fixed an issue where the localized narrative document was not always generated for Domestic Cases. | SAF-30151 |
| Narratives | 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. | SAF-30227 |
| Narratives | 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 |
| Watchlists | 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. | SAF-28217 |
Report Generation
| Category | Description | Issue Number |
|---|---|---|
| CIOMS I | Fixed an issue where the CIOMS I form reported only the primary adverse event outcome for Cases with multiple adverse events. | SAF-25864 |
| CIOMS I | Fixed an issue where Generic Product Names were excluded from CIOMS I forms. | SAF-26107 |
| CIOMS I | 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:
|
SAF-28482 |
| CIOMS I | 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. | SAF-28784 |
| CIOMS I | 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. | SAF-29299 |
| CIOMS I, FDA 3500A | 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. | SAF-28354 |
| CIOMS I, FDA 3500A | 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:
|
SAF-28781 |
| CIOMS I, FDA 3500A | 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. | SAF-28782 |
| CIOMS I, FDA 3500A | 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. | SAF-28783 |
| CIOMS I, FDA 3500A | 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. | SAF-29165 |
| E2B Export | 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. | SAF-27877 |
| E2B Export | Fixed an issue with generating E2B(R3) files where the system was missing the following field validations:
|
SAF-28032,
SAF-28218 |
| E2B Export | 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. | SAF-28256 |
| E2B Export | 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 |
| E2B Export | 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 |
| E2B Export | 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). | SAF-30388 |
| E2B Export | Fixed an issue where the Age of Parent was exported on EMA E2B(R3) files when there was no normalized value. | SAF-30874 |
| E2B Export | 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:
|
SAF-30950 |
| FDA 3500A | 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:
|
SAF-26026 |
| FDA 3500A | 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. | SAF-28687 |
| FDA 3500A | 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. | SAF-29949,
SAF-31756 |
| FDA 3500A | 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. | SAF-29968 |
| FDA 3500A | 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. | SAF-30245 |
Transmissions
| Category | Description | Issue Number |
|---|---|---|
| E2B Validation | 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. | SAF-31025 |
| Email Distributions | Fixed an issue where, when a Transmission email included an attachment, the Email Transmission state did not change to Sent or Completed. | SAF-31707 |
| Reporter Email Follow-Ups | 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. | SAF-30769 |
| Reporting Rules | 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. | SAF-28534 |
| Reporting Rules | Fixed an issue where expectedness was not evaluated correctly when cross reporting to a study for the same product. | SAF-28890 |
| Reporting Rules | Fixed an issue where the most conservative product selection was not limited to products defined within the Product Parameter. | SAF-29045 |
| Reporting Rules | 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. | SAF-29911 |
| Submissions/Distributions | 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 |
| Submissions/Distributions | 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. | SAF-30478 |
| Submissions/Distributions | 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. | SAF-30237 |
| Submissions/Distributions | 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. | SAF-28536 |
| Transmission Generation | 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. | SAF-29919 |
| Validation Rules | 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. | SAF-28392 |
| Validation Rules | 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. | SAF-28917 |
| Validation Rules | Fixed an issue where Validation Results could not be processed and saved. | SAF-28979 |
| Validation Rules | Fixed an issue with generating EMA E2B(R3) files where the system was missing the following field validations:
|
SAF-30485 |
Aggregate Reporting
| Category | Description | Issue Number |
|---|---|---|
| DSUR | 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. | SAF-29033 |
| DSUR | 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. | SAF-30883 |
| PADER | Fixed an issue where Transmission dates were incorrect on PADER Non-Primary Suspect Drug Reports. | SAF-28049 |
| PADER | Fixed an issue where, when a new PADER report was generated, previous versions of the report changed to the "Generating" state. | SAF-29529 |
System
| Category | Description | Issue Number |
|---|---|---|
| Controlled Vocabulary | Fixed an issue where, on the NMPA Report Source Controlled Vocabulary type, editing the Name field was prevented by the system. | SAF-28619 |
| Localization | 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. | SSAF-24972,
SAF-26322, SAF-23925 |
| Lifecycles & Workflows | 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. | SAF-29634,
SAF-30876 |
| Object Administration | Fixed the following issues with global (ICH) Validation Criteria:
|
SAF-28919,
SAF-29580 |
| UI/UX | 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. | SAF-29772 |
