Release Date: August 25, 2022
The following fixes are introduced in the Safety 22R2.0.2 mini release. For details about fixed issues in the Vault Platform in 22R2, see Fixed Issues in 22R2 Release.
Last Updated: November 23, 2022
| Description | Issue No. |
|---|---|
| Fixed an issue where system performance was slow during the Submit to Gateway action. | SAF-30075 |
Fixed an issue where, when importing an E2B(R2) file with multiple < drug > sections with different dosages for the same < medicinalproduct > and < drugindication >, the system created multiple Product Indication records instead of consolidating the information into a single Product Indication record.
|
SAF-30748 |
| Fixed an issue where, when the Re-evaluate Reporting Obligations action was run on a Case with multiple Transmission Profiles for the same Origin and Destination, a second Transmission was generated using a different Transmission Profile to the first-created Transmission. | SAF-31086 |
| Fixed an issue where, when generating FDA MedWatch 3500A forms, the Date of Event field (B.3) was populated with the Date of Onset on the primary Case Adverse Event record. Now, by default the Date of Event field is populated with the earliest Onset Date for any Case Adverse Event associated with the Case version. To continue populating the Date of Onset on the primary Case Adverse Event record, contact Veeva Support. | SAF-31128 |
| Fixed two issues with the Event (Reported) - Language field on a Case Adverse Event. Previously, regardless of the language in the Event (Reported) - Language field, auto-coded MedDRA terms were in English. In addition, when the Case Adverse Event was in Edit mode, the Event (Reported) - Language field became blank. | SAF-31980 |
| 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, 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 |