Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.
Note An asterisk (*) next to the issue number denotes an internally found defect filed during the development of Limited Release features.
Coding
| Category | Description | Issue Number |
|---|---|---|
| MedDRA | Fixed an issue where the MedDRA control was not showing up correctly on the Case Product Indication page. | SAF-4637* |
| MedDRA | Fixed an issue where a gear icon was appearing when you hovered over a result in the MedDRA Browser. | SAF-4599* |
| MedDRA | Fixed an issue where users were unable to move to a specific page of search results on the MedDRA Browser. | SAF-4551* |
| MedDRA | Fixed an issue where the coded MedDRA term was being populated onto the Event (Reported) field rather than the Event (MedDRA) field if the Event (Reported) field was blank. | SAF-4546* |
| MedDRA | Fixed an issue where users could not create Adverse Event Reports if the MedDRA auto-code control was enabled and Case Products could not be created or edited if the Indication section control was enabled. | SAF-4404* |
| MedDRA | Fixed an issue where some auto-created DME records were being duplicated during MedDRA imports. | SAF-3840* |
| WHODrug | Fixed an issue where the Esc and Enter keys were not producing the expected reactions of exiting and showing search results on the WHODrug Browser. | SAF-4943 |
| WHODrug | Fixed an issue where a trailing space or double space in the Product (Reported) field was causing issues with automatically populating and running the WHODrug search query. | SAF-3337 |
| Data Entry | Fixed an issue where the Frequency control in the Dosages tab was not behaving correctly when more than one product was added. | SAF-4756* |
Case Processing
| Category | Description | Issue Number |
|---|---|---|
| Data Entry | Fixed an issue with Case child records that have unit value controls where values without normalization fields were showing up as null. | SAF-4942* |
| Data Entry | Fixed an issue where age, weight, and height values were not appearing in normalized formats on the AER. | SAF-4925* |
| Data Entry | Fixed an issue where the Expedited flag was not being updated when a Case was updated to add Case Adverse Event MedRA term that matched the AESI Watchlist. | SAF-4901* |
| Data Entry | Fixed an issue where an error was appearing when saving a Case Product Substance. | SAF-4895* |
| Data Entry | Fixed an issue where Age appeared as -10 years on FDA 3500A forms when the value entered on the Case was 0 decades. | SAF-4849* |
| Data Entry | Fixed an issue where Dosage information was not appearing correctly when Dose Unit was left blank but Dose Unit Text was populated on FDA 3500A and CIOMS I forms. | SAF-4819* |
| Data Entry | Fixed an issue where Study Registration was not being copied over from a Study to an E2B-imported open Case if the E2B files did not contain the Study Registration. | SAF-4773* |
| Data Entry | Fixed an issue where, when both Age Value and Age Unit were entered, only the Age Unit was appearing on the AER. | SAF-4772* |
| Data Entry | Fixed an issue where, if text was entered in the Medical History Text field on the original Case but Reason Omitted was entered on the Follow-up, both text and Reason Omitted were appearing on the Follow-up Case. | SAF-4755* |
| Data Entry | Fixed an issue where users with an assigned User Role were seeing an error on the Case Products page when Dosage or Indication section controls were enabled. | SAF-4639* |
| Data Entry | Fixed an issue where the Receipt Date field was not appearing highlighted to indicate that it is a required field on AER, Case, and Imported Case. | SAF-4525 |
| Data Entry | Fixed an issue where Frequency was not being displayed correctly and expected notifications were not being sent if the value in the Dose Text field exceeded 3 digits. | SAF-4326* |
| Data Entry | Fixed an issue with the Case Product Dosage subsection where the Reason Omitted fields were not being replaced by disabled Time/Time Zone fields unless the user entered a complete date for the First or Last Admin Date. | SAF-4058* |
| Data Entry | Fixed an issue where a system error appeared if the Event Onset Date was before the patient's Date of Birth on an Adverse Event Report. | SAF-3553* |
| Data Entry | Fixed an issue where the Frequency field in Product Dosage Details was not appearing correctly on Microsoft Edge. | SAF-3549* |
| Data Entry | Fixed an issue where the dropdown menu for Reason Omitted in the Patient Initials/ID field was not appearing correctly. | SAF-3544* |
| Data Entry | Fixed an issue where the system was saving a blank Product Indication after the user deleted the text entered. | SAF-3497* |
| Data Entry | Fixed an issue where, if some text was entered into an Indication record, it remained open on the Case Product Page even after the user selected Cancel. | SAF-3478* |
| Data Entry | Fixed an issue where users were unable to add new Drug Products to a Case because the page would not load with Indication Section Control was enabled. | SAF-3476* |
| Data Entry | Fixed an issue where the Age Group was disappearing if the Date of Birth on an Adverse Event Report was removed. | SAF-1345 |
| Security Profiles | Fixed an issue where users with the Case Processing security profile were encountering an error when trying to view the Case Product Dosages screen. | SAF-4839* |
| Record Naming | Fixed an issue when opening a Follow-Up Case, where Case Adverse Events from the initial Case were being renamed with a name differentiation suffix instead of those records on the Follow-Up Case. | SAF-4705 |
| Duplicate Case Detection | Fixed an issue where you could not create a Follow-Up Case from a potential match if the Worldwide UIDs were capitalized differently. | SAF-4352* |
Safety Data Exchange
| Category | Description | Issue Number |
|---|---|---|
| E2B Import | Fixed an issue where Dose Unit Text was being populated with {} if no value was entered and {non standard} if a custom unit was entered in E2B (R2) imported files. | SAF-4757* |
| E2B Import | Fixed an issue where a warning appeared about rounding the Dose value to an acceptable number of characters when a custom Dose Unit was used in E2B (R2) imported files. | SAF-4718* |
| E2B Import | Fixed an issue where, during an E2B import, the correct TermID Version was not being mapped when there was an RoA TermID match. | SAF-4683* |
| E2B Import | Fixed an issue where blinded E2B (R2) files were not being imported successfully. | SAF-4359* |
| E2B Import | Fixed an issue with E2B imports where the most recent New Info Date was not being mapped onto the Date Received by Manufacturer field on CIOMS I and FDA 3500A forms. | SAF-4106 |
| E2B Import | Fixed an issue where, during an E2B import, an assessment method and result were used to populate two Case Assessments when the second assessment was missing the method and result. | SAF-3740 |
| E2B Import | Fixed an issue where generating multiple Transmission records for the same Case, such as a Submission and a Distribution, sometimes lead to the same E2B file being attached to each Transmission. | SAF-3498* |
| E2B Import | Fixed an issue with content-protected E2B R2 files where the patient's Date of Birth field was empty instead of being masked when a Reason Omitted was entered. | SAF-3486* |
| E2B Import | Fixed an issue with content-protected E2B R2 files where the Continuing field in Medical History was not being masked. | SAF-3484* |
| E2B Import | Fixed an issue where an Illegal Argument Exception was reported if a product did not have a placeholder in a case with a Blinded Arm. | SAF-3474* |
| E2B Import | Fixed an E2B import issue where the Case Receipt Date was set to the date when the E2B file was uploaded instead of mapping the Date of Creation from the E2B file. | SAF-3458 |
| E2B Import | Fixed an issue where form generation was failing when a Case Narrative Template included a merge field token that exceeded the field's character limit on FDA 3500A forms. | SAF-3039 |
| E2B Import | Fixed an issue where, when importing an E2B file from a Gateway Transmission or the Receive E2B API, the transmission message name format on the Inbound Transmission was incorrect. | SAF-2332 |
| Aggregate Reports | Fixed an issue where PADER Summary tabulations counted Cases with a New Info Date set outside of the aggregate report reporting period. | SAF-4827* |
| Aggregate Reports | Fixed an issue with DSUR table generation where all cases were included in line listings, regardless of relatedness. Only cases with Adverse Events related to the suspect product will now be included. | SAF-4532 |
| Aggregate Reports | Fixed an issue where Aggregate Report line listings did not include follow-up cases that had New Info Dates within the Reporting Period. | SAF-4239* |
| Aggregate Reports | Fixed an issue where the Case was not being counted in DSUR and PBRER aggregate reports if the Study Blinded field was not set to a value (Yes or No). | SAF-3466 |
| Aggregate Reports | Fixed an issue where Unblinded Cases with blind-protection enabled were not being counted in DSUR and PBRER aggregate reports. | SAF-3404 SAF-3394 |
| Aggregate Reports | Fixed an issue where a server error was appearing when generating the next Aggregate Report if the IBD and Reporting Period were not populated on the Reporting Family. | SAF-1784 |
| Aggregate Reports | Fixed an issue where users who were assigned the Safety Writer application role could only generate aggregate reports using workflow tasks and not with the Generate Report Tabulations user action. | SAF-1729 |
Submissions
| Category | Description | Issue Number |
|---|---|---|
| FDA 3500A/CIOMS I | Fixed an issue where codes were being populated instead of simplified descriptors when users selected Reason Omitted values for Start and End dates on FDA 3500A and CIOMS I forms. | SAF-4005 |
| FDA 3500A/CIOMS I | Fixed an issue where test result ranges were not appearing in Section B6 of FDA 3500A forms and Section 7+13 of CIOMS I forms if data was entered in the Result (text) field. | SAF-3964 SAF-3959 |
| FDA 3500A/CIOMS I | Fixed an issue where country codes were being used instead of full country names in Section G.1 of FDA 3500A forms and Section 24a of CIOMS I forms. | SAF-3847 |
| FDA 3500A/CIOMS I | Fixed an issue where concomitant product generic names were not populated on the FDA 3500A and CIOMS I forms. | SAF-3738 |
| FDA 3500A/CIOMS I | Fixed an issue where the global manufacturer name and address were not populated on FDA 3500A and CIOMS I forms when generated to preview the Case. This issue did not affect FDA 3500A and CIOMS I forms generated for Distributions and Submissions. | SAF-3736 |
| FDA 3500A/CIOMS I | Fixed an issue where only country codes were being used in Sections E.1 and G.1 on FDA 3500A forms and Sections 1a and 24a on CIOMS I forms. The system will now populate these fields with both the country code and the full country name. | SAF-3733 |
| FDA 3500A/CIOMS I | Fixed an issue where calculated ages were populated as a decimal number instead of a whole number on the FDA 3500A and CIOMS I forms. | SAF-3732 |
| FDA 3500A/CIOMS I | Fixed an issue where blank dates were populated as question marks (???) on FDA 3500A and CIOMS I forms. To improve clarity, blank dates are now populated as dashes (---). | SAF-3727 SAF-3726 |
| FDA 3500A/CIOMS I | Fixed an issue where narrative text describing the Adverse Event was not cropped when the 100K character limit was reached on the FDA 3500A and CIOMS I forms. | SAF-3537* |
| FDA 3500A | Fixed an issue where the Case name was being cut off when it exceeded 20 characters in Section G9 of FDA 3500A forms. | SAF-4061* |
| FDA 3500A | Fixed an issue where the patient’s weight in Section A.4 was being rounded off on FDA 3500A forms. | SAF-4013 |
| FDA 3500A | Fixed an issue where Dose amounts in Sections C.2 and C.3 were being rounded off on FDA 3500A forms. | SAF-4009 |
| FDA 3500A | Fixed an issue where the initial Receipt Date instead of the New Info Date was mapped to Section G.4 on FDA 3500A forms. | SAF-3957 |
| FDA 3500A | Fixed an issue where the form title and the space between Sections C.8 and D was misaligned on FDA 3500A forms. | SAF-3880 |
| FDA 3500A | Fixed an issue where incorrect report type checkboxes were populated for SAEs and Serious Cases on FDA 3500A forms. | SAF-3879 |
| FDA 3500A | Fixed an issue where single-digit dates were being populated in an incorrect format in Section A.2 of FDA 3500A forms. | SAF-3875 |
| FDA 3500A | Fixed an issue where, in the absence of information about the product being compounded, Section C.6 was populated with No on FDA 3500A forms. | SAF-3867 |
| FDA 3500A | Fixed an issue where the reported (verbatim) event text was not populated before the MedDRA term on the FDA 3500A form. | SAF-3730 |
| FDA 3500A | Fixed an issue where the Foreign checkbox was filled in section G.3 on the FDA 3500A form when the reporter country was blank on the Case. | SAF-3729 |
| FDA 3500A | Fixed an issue where the name of the Manufacturer/Compounder was being cut off in Section G.1 of FDA 3500A forms. | SAF-3722 |
| FDA 3500A | Fixed an issue where the Initial Reporter's address was being cut off in Section E.1 of FDA 3500A forms. | SAF-3721 |
| FDA 3500A | Fixed an issue where product registration numbers were populated in section C.1 on the FDA 3500A form. | SAF-3720 |
| FDA 3500A | Fixed an issue where the Foreign checkbox was filled in section G.3 on the FDA 3500A form when the reporter country was blank on the Case. | SAF-3467* |
| CIOMS I | Fixed an issue where CIOMS I form generation failed if the Case Version field was left blank. | SAF-4936 |
| CIOMS I | Fixed an issue where a line break was not appearing between multiple Suspect Drugs on the overflow page of CIOMS I forms. | SAF-4789* |
| CIOMS I | Fixed an issue where there was no indication of information being continued onto an overflow page when information of more than 2 Suspect Drugs was entered on CIOMS I forms. The message (Continued on Additional Page) will now appear at the end of the section. | SAF-4541 |
| CIOMS I | Fixed an issue where the Dosage Text field was not being mapped onto Section 15 of CIOMS I forms. | SAF-4406 |
| CIOMS I | Fixed an issue where Sender’s Comments were not appearing in the overflow field of Section 7+13 on CIOMS I forms. | SAF-4405 |
| CIOMS I | Fixed an issue where Additional Company Remarks were not being populated onto Section 26 of CIOMS I forms. | SAF-4336 |
| CIOMS I | Fixed an issue where the initial Receipt Date instead of the New Info Date was mapped to Section 24c on CIOMS I forms for Follow-Up Cases. | SAF-3961 |
| CIOMS I | Fixed an issue where product registration numbers were populated in Section 14 on the CIOMS I form. | SAF-3775 |
| CIOMS I | Fixed an issue where Section 25b detailing Reporter Information was missing from CIOMS I forms. | SAF-3774 |
| CIOMS I | Fixed an issue where the outcome of the primary adverse event was not being displayed as a Case-Level outcome in Section 7+13 of CIOMS I forms. | SAF-3742 |
| CIOMS I | Fixed an issue so that the patient’s age in Section 2a is populated with the patient’s age group if no other age details are available on CIOMS I forms. | SAF-3741 |
| CIOMS I | Fixed an issue where dates were being populated in a YYYY-MM-DD format instead of a DD-MMM-YYYY format on CIOMS I forms. | SAF-3739 |
| CIOMS I | Fixed an issue where the full name and address of the manufacturer was not appearing in Section 24a of CIOMS I forms. | SAF-3735 |
| CIOMS I | Fixed an issue where the reported (verbatim) event text and the MedDRA term for adverse events were not populated at the start of section 7+13 on the CIOMS I form. | SAF-3731 |
| CIOMS I | Fixed an issue where only primary suspect drugs, doses, indications, and RoAs were appearing in Section II of CIOMS I forms. | SAF-3723 |
| Transmissions | Fixed an issue where an inactive Head of Safety user was being selected as the Sender User for a Transmission record instead of the current Head of Safety. | SAF-4435 |
| Transmissions | Fixed an issue where Study Submissions were being created for all serious cases. Submission generation will now be limited to Study Cases and follow-ups that are classified as SUSAR, and follow-ups that meet downgrade SUSAR criteria. | SAF-3503 |
Document Management
| Category | Description | Issue Number |
|---|---|---|
| Merge PDF | Fixed an issue where the Merge Binder to PDF function was failing without an error notification when users did not have the required permissions. | SAF-4116 |
