22R1 Fixed Issues

Learn about fixed issues in 22R1.

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 22R1. For details about fixes issues in the Vault Platform in 22R1, see the Vault Release Notes.


Intake

Category Description Issue Number
E2B Import Fixed an issue where the Primary Product was unable to be changed on an E2B imported Case. SAF-16345
E2B Import Fixed an issue where, when creating a Case from an E2B imported Inbox Item, a duplicate Case Product Substance was created. SAF-23617
E2B Import Fixed an issue where the Meddra Version was not populated with "-" when importing an E2B file to AER with a blank MedDRA Version. This resulted in the E2B Import field being set to No. SAF-25245
E2B Import Fixed an issue where, when importing an E2B(R2) file to AER, Inbox Item, or Case, the Case Seriousness (A.1.5) was mapped to all Adverse Events instead of considering the Term highlighted by the reporter (B.2.i.3) field value for each Adverse Event. SAF-25996
E2B Import Fixed an issue where, when importing an E2B(R2) file to AER or Inbox Item, the test Result (B.3.1d) and Test Result (unit) (B.3.1e) were mapped to Normal Low Value (B.3.1.1) and Normal High Value (B.3.1.2) fields. SAF-25802
E2B Import Fixed an issue where, when importing an EMA E2B(R3) file to Inbox Item, the Inbox Item was not created and the document went to Error state. SAF-27553
E2B Import Fixed an issue with E2B(R3) import, where an error appeared indicating the result_text__v value exceeded the 2000 character limit in certain scenarios when the limit was not exceeded. SAF-27287
E2B Import Fixed an issue with E2B import to Inbox Item, where if the dose frequency unit was "Cyclical," "As Necessary," or "Total", the value was not imported to the Frequency field. This issue did not impact AERs. SAF-27141
E2B Import Fixed an issue where Case Assessments and Assessment Results imported from E2B(R2) to Inbox Item were not copied to the Case upon Case promotion. SAF-27080
E2B Import Fixed an issue with E2B(R2) import, where if data element B.1.9.4b Autopsy-determined Cause(s) of Death did not match to a MedDRA term, the value was not imported. Now, the system will import the text value if it does not match to a MedDRA term. SAF-27112
E2B Import Fixed an issue with E2B(R2) import where the Reaction Recurrence (B.4.k.17.1) was not imported to Inbox Item or AER. SAF-27110
E2B Import Fixed an issue where the user was not notified when D.2.2a (Age at Time of Onset of Reaction / Event (number)) was truncated from an imported E2B file. SAF-25411
Document Intake Fixed an issue for Inbox Items created from an imported document where, when only the "Other medically important condition (specify)" checkbox was selected and extracted, an incorrect P3 Priority was suggested and a "Seriousness was not found" rationale was provided. SAF-24862
Email Intake Fixed an issue with manual Inbox Item intake from emails where the Study Arm field was hidden on the Inbox Item. SAF-26462
Email Intake Fixed an issue where some emails to vault were not creating Inbox Items due to the email subjects exceeding 100 characters. SAF-26595
Data Entry Fixed an issue where, when the Localization field was selected or updated on an Inbox Item, the localized text fields were not updated on the Inbox Item page. SAF-26684
Data Entry Fixed an issue in a sandbox environment where if a Reporter Qualification value was selected, a server error appeared and the Identifiable Reporter field was set to No. SAF-27489
Verification Fixed an issue where, when a user tried to verify the Awareness Details, a server error appeared due to duplicate entries existing for one field. SAF-24406
Verification Fixed an issue where, when a user tried to verify the Awareness Details, a server error appeared due to duplicate entries existing for one field. This is a previous fixed issue (SAF-24406) from 21R3.0.3 with a newly implemented solution. Now, if a field is updated more than once, the value reflects the most recently entered data. SAF-24535
Duplicate Detection Fixed an issue where Cases with more than two blank fields used in duplicate detection were not considered as potential matches when promoting an AER or Inbox Item. SAF-23428
Duplicate Detection Fixed an issue where duplicate detection did not return any potential matches if Matching Contents contained special characters and operators, such as " ' ( ) *. Now, special characters and operators are treated as normal characters and do not impact duplicate detection. SAF-24737
Duplicate Detection Fixed an issue where, when a Case Product or Case Adverse Event was deleted, the Matching Contents record was not updated and these records were still being considered in duplicate detection. SAF-25711
Duplicate Detection Fixed an issue with UID matching (UID, WWUID, External System UID, Case Identifier) where duplicate search was case sensitive. Thus, if an Inbox Item and Case UID matched but were not in the same Case sensivity, duplicate search did not detect this field as a match. SAF-26804
Case Promotion Fixed an issue where, when an AER was promoted to a Follow-Up Case, the Study Registration was not downloaded from the Study library and was not added to the Case. SAF-23799
Case Promotion Fixed an issue where, when promoting an E2B imported AER or Inbox Item with a narrative document to a Case, the merge fields used information from the Case as well as the AER/Inbox Item and the narrative document was linked to both the Case and the AER/Inbox Item. SAF-11415
Case Promotion Fixed an issue with domestic Case processing where the localized Patient Contact was not generated for the Case after Case promotion. SAF-23134
Case Promotion Fixed an issue where, when promoting an Inbox Item with Localization set to a non-global value, the English translation on the Case Medical History was overwritten by the reported term in the native MedDRA language. SAF-22821
Case Promotion Fixed an issue where Case Product Substances were not snapshotted upon promoting an Inbox Item. SAF-22484
Case Promotion Fixed an issue where the Race Reason Omitted field value on the Inbox Item was not copied over to the Case upon Case promotion. SAF-24660
Case Promotion Fixed an issue where, when promoting an Inbox Item to Follow-Up from the Case Compare page, the Source MedDRA Version was not set on the Follow-Up Case. SAF-24917
Case Promotion Fixed an issue where the Study-type Case Product Registration and Product fields were not populated on the Case upon promoting an E2B imported Inbox Item. SAF-23974
Case Promotion Fixed an issue with E2B(R2) and E2B(R3) imported Inbox Items and AERs where, after promoting to Case, the unknown Case Assessment records from the E2B file were not created on the Case. SAF-25006
Case Promotion Fixed an issue with system-generated AERs and Inbox Items where, if the field value for Case Contact Rank is not 1, the Primary Source in the Case Contact record was left blank upon Case promotion. SAF-25447
Case Promotion Fixed an issue where, after importing an open Study to Inbox Item and promoting to Case, the Product and Product Registration fields were blank. SAF-25765
Case Promotion Fixed an issue where an error message appeared and a Follow-Up Case was unable to be created after deleting the Product Indication and Dosage record on the Case Compare page from an initial domestic Case. SAF-24724
Case Promotion Fixed an issue where, when a case processing user attempted to mark an Inbox Item as Mark as Follow-Up on the Potential Matches page, an error appeared stating the user does not have permission. SAF-24866
Case Promotion Fixed an issue where, when a manual Inbox Item with a Study (and Study Arms) was promoted to Case, the Study Product field on the Case was blank. SAF-26306
Case Promotion Fixed an issue with creating a Follow-Up Case from an Inbox Item where, if the blank option on the Adverse Event section dropdown was selected on the Case Compare page, a blank Adverse Event record was promoted along with the other Adverse Events. SAF-26179
Case Promotion Fixed an issue where, when an Inbox Item containing two Combination Products was promoted, only one Combination Product was included on the Case. SAF-27004
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 Processing

Category Description Issue Number
Case Promotion Fixed an issue with E2B imported Inbox Items with Parent Information. When the Study field was set on the Inbox tab in list view, this resulted in only the Parent Case Study being updated upon Case promotion and not the Patient Case Study. SAF-26661
Case Promotion Fixed an issue where, after creating a Case Product Registration record for a Japanese Domestic Case and promoting the Case to Follow-Up, the Follow-Up Case did not contain the Case Product Registration record. SAF-25180
Case Promotion Fixed an issue where, when a Study Case was promoted, the Case Product name was not included in the name of the Case if there was no Study Product name. Now, if there is no Study Product name, the system includes the Primary Product name in the name of the Case, if it exists. SAF-24312
Data Entry Fixed an issue where an error message did not appear when a user exceeded the maximum character limit for the Reporting Summary app control field. SAF-23684
Data Entry Fixed an issue where, when the ISO character "Z" was included in the date field value, this resulted in an incorrect field value. SAF-24625
Data Entry Fixed an issue where Reason Omitted (nullFlavor) values were incorrectly displayed for some FDA VAERS Regional fields. SAF-25237
Data Entry Fixed an issue where the Study Number on the Case was unable to be updated after being renamed. SAF-26817
Data Entry Fixed an issue where, when a Study with a name that exceeds 1500 characters but is less than 2000 characters was selected on a Case, the Case could not be saved. SAF-22283
Case Assessment Fixed an issue where, if a serious Case Adverse Event was added to an existing Case, the system-generated Case Assessment Result for the reporter was not automatically assigned the "Source Type". SAF-26839
Narratives Fixed an issue where, when an Inbox Item with Localization set to a non-English value was promoted to Case, the narrative document was not created for the local Case. SAF-26415
Domestic Case Fixed an issue where, an additional blank Product record was created for a Localized Case upon Case promotion. SAF-24628
Domestic Case Fixed an issue where, when an Inbox Item with Localization set to a non-global value contains an Indication and references a combination product with multiple product constituents, a Domestic Case failed to create upon Case Promotion. SAF-27196
Auto-Calculation Fixed an issue where the Age (normalized) field was rounded up instead of being truncated. SAF-24609
Watchlists Fixed an issue where an error appeared when a Vault Owner tried to update the Default Seriousness field on the system-provided DME watchlist (dme__v). Now, fields such as Default Seriousness and Watchlist Exclusions can be configured for the DME watchlist. SAF-25022
Follow-Ups Fixed an issue with E2B imported Inbox Items where, after promoting to an Initial Case and, subsequently, to a Follow-Up Case, Case Assessment records were created for all concomitant medications. SAF-24430
Localization, Follow-Ups Fixed an issue where any additional updates after Case promotion made to the Follow-Up global case were not synched to the localized Case(s). SAF-26807
Localization Fixed an issue where, when the Evaluate Submission Obligations action was run on a Case created from an E2B imported Inbox Item with a registration in a foreign country, the system created a new English narrative document on the generated localized Case instead of using the existing narrative document in the local language. SAF-22746
Localization Fixed an issue with localized Cases where, when the Case narrative document was updated with text in the local language, the localized Case narrative preview was not updated to display the text in the local language and instead displayed it in English. SAF-23668
Blind Protection Fixed an issue where, when the bulk unblind operation was run, the Case was still included in the blue category (closed Cases that have not been unblinded) and a follow-up version was created. SAF-25368

Coding

Category Description Issue Number
MedDRA Fixed an issue where a cleanup operation of duplicate MedDRA records failed when the vault contained Product Datasheets which referenced a duplicate MedDRA record but was not referenced by a watchlist. SAF-21516
MedDRA Fixed an issue where, when loading a MedDRA .zip file into different vaults, an inconsistent number of records between vaults were displayed. The MedDRA Hierarchy for CMQ and Vault Reporting feature addresses this issue with a new user action to download the full active MedDRA version from the central dictionary to a vault. SAF-24576
MedDRA Fixed an issue where, when searching for certain MedDRA terms, the MedDRA browser search was not prioritizing exact matches when returning search results. SAF-26331
MedDRA Fixed an issue where, when the Terms Hierarchy was applied and a term is entered in any MedDRA language except English and Japanese, the LLT term under the hierarchy could not be found. SAF-25419
MedDRA Fixed an issue with the local MedDRA dictionary where, when the Terms Hierarchy was applied, no results were shown. SAF-25416

Aggregate Reporting

Category Description Issue Number
DSUR Fixed an issue where, when Indicate Unexpected Terms was enabled, the DSUR log sheet for Cumulative Summary Tabulation of Serious Adverse Reactions included unrelated Cases. The total number of events was not impacted in the tabulation. SAF-23459
DSUR Fixed an issue with the Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials report generation where the Expectedness calculation was not consistent. SAF-25071
PSUR Fixed an issue with PSUR reports where, when multiple Core Datasheets contained the same MedDRA term, the Expectedness was set using an incorrect or unrelated Core Datasheet. SAF-24991
PADER Fixed an issue with the PADER Summary of ADR from Postmarketing Sources report where, if the Case Assessment Expectedness was overridden, the adverse event was detected as both labeled and unlabeled in the generated report. SAF-22903
PADER Fixed an issue where, when a PADER Non-Primary Suspect Product Report was generated, an older Case version with a non-primary suspect product was included. SAF-25207

Report Generation

Category Description Issue Number
E2B Export Fixed an issue for FDA E2B(R2) combination product reports by supporting partial dates for the Case Product Expiration Date field. SAF-24626
E2B Export Fixed an issue with a Localized Case translated from a Global Case where, when an ICH E2B(R3) report was generated, Event (Reported) used data from the Localized Case instead of the Global Case. SAF-24588
E2B Export Fixed an issue with ICH E2B(R2) reports where the DOCTYPE DTD (document type definition) could not be modified. SAF-19096
E2B Export Fixed an issue with E2B(R2) export where, when a distribution with Study Content Protection set to Mask Unblinded Content was created, the masked file contained susbtance information. SAF-25502
E2B Export Fixed an issue where, when an ICH E2B(R2) regulatory report was generated, the header contained "FDA". SAF-24548
E2B Export Fixed an issue with E2B(R3) export where the Dosage Text (G.k.4.r.8) field was not truncated to 2000 characters upon export. SAF-23775
E2B Export Fixed an issue with E2B(R2) export where, when the Patient Content Protection was set to Mask PII, the Date of Birth field was not exported when it should have been exported as PRIVACY. SAF-25753
E2B Export Fixed an issue with E2B(R3) export where, when the Mask Reporter for Postmarket Non-Literature Case setting was enabled, the nullFlavor values were not masked upon generating the report. SAF-25725
E2B Export Fixed an issue where, when a transmission document was generated on a submission with Reason set to Amendement and Reason Text containing more than 200 characters, the Reason Text was still exported to B.5.1 (Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information) in the E2B(R2) files. SAF-26881
E2B Export Fixed an issue with EMA E2B(R3) export where if a Study contained a Registration Number from any EU country, the Country was updated to "EU" on the generated EMA E2B(R3) XML file. This led to submission rejections and E2B ACK warnings. SAF-27454
E2B Export Fixed an issue where, when the Patient RoA was selected on the Inbox Item, the Patient RoA TermID and Patient RoA TermID Version were not set, which led to G.k.4.r.10.2a (Route of Administration TermID Version Date / Number) and G.k.4.r.10.2b (Route of Administration TermID) not being exported to E2B(R2 and R3). SAF-26966
E2B Export Fixed an issue with E2B(R2) export where certain MedDRA data elements contained the term name in addition to the MedDRA LLT code. The system will now export the data elements with only the MedDRA LLT code. SAF-26938
E2B Export Fixed an issue with the E2B SDK extension for E2B(R2) where the <literaturereference> element was not being generated. SAF-26571
E2B Export Fixed an issue where, when exporting an XML file with a blank F.r.3.2 (Test Result value / qualifier) and F.r.3.3 (Test Result unit), an empty tag was included in the XML file, which led to a failed import. SAF-26754
E2B Export Fixed an issue where, when exporting to E2B(R2 and R3), G.k.4.r.6a (Duration of Drug Administration (number)) did not truncate to 5 characters. SAF-26277
E2B Export Fixed an issue with E2B(R2 and R3) form generation where validations were not triggered and the transmission document was successfully generated with an error notification stating the document was not generated. SAF-25912
FDA 3500A Fixed an issue where, when an FDA MedWatch 3500A form was generated, the UID/MFR Report # was not completely printed on the form for some cases. SAF-26416
FDA 3500A Fixed an issue where, when an FDA MedWatch 3500A form was generated, section B2 (Outcome Attributed to Adverse Event) only contained the primary Case Adverse Event Seriousness values and did not contain those for the non-primary Case Adverse Event. SAF-26762
FDA 3500A Fixed an issue where the FDA MedWatch 3500A form failed to generate when a narrative document was uploaded to the Case. SAF-25832
FDA 3500A Fixed an issue with FDA MedWatch 3500A form generation where if Patient Initials was blank, Section A.1 on the form (Patient Identifier) was not populated with Investigation MRN. SAF-24549
CIOMS I Fixed an issue where the CIOMS I file failed to generate due to a missing delimiter in the Case Assessment name. SAF-24669
CIOMS I Fixed an issue where an Index Out of Bounds error appeared and the CIOMS I report failed to generate for a distribution. SAF-25024
CIOMS I Fixed an issue with Date Received by Manufacturer (24c) field mapping when generating the CIOMS I form. Now, the New Info Date field will be used to populate Date Received by Manufacturer on the form for both Initial and Follow-Up Cases. SAF-25679
CIOMS I Fixed an issue with CIOMS I form generation for Cases with Combination Products where assessment results were generated for device constituents. Assessment results should only be generated for products listed in Section 14 (drug constituents). SAF-26125
CIOMS I, FDA 3500A Fixed an issue with CIOMS I and FDA MedWatch 3500A report generation where, when the Study Product dosage was blinded, the Frequency on the report was blank instead of displaying *****. SAF-26092
E2B Export, CIOMS I, FDA 3500A Fixed an issue where inconsistent timezones were used to determine the date in generated forms. Now, CIOMS I and FDA 3500A reports will use Vault's default timezone. For E2B exports, users can convert the date to use the appropriate timezone. SAF-25344

Transmissions

Category Description Issue Number
E2B Validations Fixed an issue where the EMA validation rule for G.k.9.i.2.r.1.EU.1 (EU Source of Assessment) was missing. SAF-25066
E2B Validations Fixed an issue where validation did not run when the Evaluate Regulatory Conformance action was triggered on a global Case with only E2B format submissions for localized Cases. SAF-26189
E2B Validations Fixed an issue with ICH Case-level validations where multiple records were created for the validation criteria (one record for each agency it was run for) in the summary file. SAF-24742
Validation Rules Fixed an issue where using Vault Loader to update Study Persons was unsuccessful if the First Name and Email fields were left blank. This is due to system-managed validation rules for the Person object which limit the number of characters and does not accept null fields. Now, First Name Length and Email Address Length validation rules can be edited. SAF-24993
Reporting Rules Fixed an issue where, when a Vault Owner tried to update the Distribution Rules field on the EMA ICSR Reporting Rule Set, an error appeared stating the field can not be updated. SAF-23053
Reporting Rules Fixed an issue where, when the Upgrade rule was configured for custom rule sets, the rule did not pass for an upgraded Case. SAF-25243
Reporting Rules Fixed an issue where Suspect = Yes was configured at the rule set level and could not be overridden for a Case with a Drug Role that was updated to "Drug Not Administered". As part of this fix, the Suspect = Yes rule set-level parameter was removed from the EMA, FDA, and PMDA rule sets. SAF-24953
Reporting Rules Fixed an issue where the Due in Days Override parameter was overriden when being used in a rule set that inherits a Base Rule Set. SAF-26273
Reporting Rules Fixed an issue where the most conservative product selection method was not evaluating correctly in Cases with Combination Products. SAF-27293
Reporting Rules Fixed an issue where the most conservative product selection method was generating Submissions with a mismatched Transmission Profile in Cases with Combination Products. SAF-27292
Reporting Rules Fixed an issue affecting clinical trial study cases where, in both evaluating the Expected reporting rules parameter and determining the Most Conservative Product, the system was using Local Datasheets for regional expectedness.
Now, the system will only explicitly evaluate regional expectedness for non-study and postmarket study cases.
SAF-26144
Submissions/Distributions Fixed an issue where, when the Re-evaluate Submission/Distribution action was run on a Case, a NullPointerException (NPE) error appeared if the country on the Expectedness record did not match the registration country. SAF-22897
Submissions/Distributions Fixed an issue where a submission record could not generate if the agency was missing the API name. SAF-23053
Submissions/Distributions Fixed an issue where, when upgrading a Follow-Up Case to a SUSAR, an incorrect Due Date was populated on the Transmision record (15-day instead of 7-day SUSAR). SAF-20131
Submissions/Distributions Fixed an issue where a submission to the FDA containing Northern Ireland country code "XI" was rejected. Now, submissions to the FDA will use the country code "GB" for Northern Ireland whereas submissions to all other destinations will use the 2-character country code in Vault. SAF-24493
Submissions/Distributions Fixed an issue where, after the Evaluate Regulatory Obligations action was run on a Case with Localization set to a non-global value and a distribution was created, the Substance Name was not copied to the Localized Case Product Substance. SAF-18894
Submissions/Distributions Fixed an issue where, when the Evaluate Reporting Obligations action was run on a Case containing an Investigational Study Product and a Placebo Study Product set as unexpected and related (SUSAR), submissions were still generated with the SUSAR rule. SAF-27796
Transmission Generation Fixed an issue where, duplicate Transmission records were generated for the same destination if multiple Transmission Profiles exist for the origin and destination pair. SAF-26518
Gateway Transmissions Fixed an issue where AS2 connectivity between two Safety vaults could not be established and the Distribution record was moved to Error state due to port 4080 not being open for outbound transmission. SAF-22759
Partner and MAH Distributions Vault Safety will now generate Distributions for Cases containing a Case Product or Product Registrations which were members of a Reporting Family for a Partner or MAH Distribution List when the Case has a "Report Type" of Study. Previously, Study Case could only trigger partner Distributions through matching on the Study or Study Registration. SAF-26512
Partner and MAH Distributions Fixed a limitation where the Most Conservative Product reporting rules evaluation method was not evaluating for Distributions through a Partner or MAH Distribution List. SAF-25223

System

Category Description Issue Number
Audit Log Fixed an issue where, upon importing an Inbox Item from an Intake API or E2B file, the record ID for multiple fields were displayed in the Inbox Item audit log. SAF-22865
Audit Log Fixed an issue where the Inbox Item audit trail logged the unverified Product section as "Verified" instead of "Edited" when the Study was changed in the Details section. SAF-24913
Audit Log Fixed an issue where, when some Inbox Item sections were verified and saved, certain fields were logged in the Old Value and New Value columns on the audit trail. SAF-24452
Audit Log Fixed an issue where each time the Inbox Item Details section was saved with no changes, the audit trail logged "Record saved with no changes". In addition, if the Study field was populated when saving the Details section, the audit trail logged changes from the Product section when there were none. SAF-24327
Audit Log Fixed an issue where, when any Inbox Item section or record was verified with no changes made, the old and new values on the audit trail still displayed all the fields. SAF-25025
Notification Fixed an issue where an incorrect error message was displayed when the New Info Date was blank during Inbox Item promotion to Case. SAF-25454
Lifecycles & Workflows Fixed an issue where Localized Cases were moved to Closed state upon promoting them to a Follow-Up Case. SAF-25154
Vault Loader Fixed an issue where an error appeared when a user tried to load more than 250 Case Assessment records in one batch using Vault Loader. SAF-26073
Object Administration Fixed an issue where the Result (qualifier) picklist field in the Case Test Result object contained invalid values. SAF-25032
Vault Management Fixed an issue where vaults provisioned after the 20R1 release contained at least one controlled vocabulary API name that did not match that of vaults provisioned before the 20R1 release. SAF-26091
Controlled Vocabularies Fixed an issue where some Japanese terms used in Controlled Vocabularies were incorrect or not aligned with the Health Authority. SAF-22748
Performance Fixed an issue where, after deleting an Inbox Item subsection or editing a Product Dosage record, these changes were not saved on the Inbox Item upon selecting the global save button. SAF-25762
UI/UX Fixed an issue where, when the Void Case user action was triggered, the pop-up message to indicate the user does not have permission was displayed as an error. SAF-25446