1. Release Notes—What's New
  2. What's New
  3. Enhancements to Oracle Argus Safety Japan
  4. Enhanced PSR and ReSD reports
  5. Generic updates

Generic updates

  • All the existing reports that are generated before the upgrade are retained as it is in the old format.
  • All the reports that are generated or re-generated after the upgrade are generated in the updated format or layout as mentioned for individual forms.
  • The existing profile switch Event counting logic for P.S.R Form 3, 4 and ReSD Form 4, 5 is renamed as Event counting logic for P.S.R Form 3, 4 and ReSD Form 10, 11.

  • The configuration parameters for PSR Form 3, PSR Form4, ReSD Form 10, and ReSD Form 11 are editable even for the second time frame or above, similar to a fresh report (initial time frame).

    A new option under the profile switch Event Counting Logic for PSR Form 3, PSR Form 4, ReSD Form 10, and ReSDForm 11 is added to allow the users to configure the count each event field from a case with the timeframe where the case was last reported along with the count each event field from a case with the timeframe where the case was first reported.

  • Common profile switch Listedness Assessment Source for PSR and ReSD is deprecated.

    A new report-level configuration is added as Listedness Assessed on to configure the assessment parameter for the reaction: Case Assessment and Datasheet. PSR and ReSD reports based on the common profile switch considers the new report-level configuration for the new created reports.For the existing reports prior to upgrade, the option for Listedness Assessed on is set based on the value set in the common profile switch Listedness Assessment Source for PSR and ReSD during upgrade.This report-level parameter is considered for PSR Form 3, PSR Form 4, ReSD Form 10 (for Case listing only), ReSD Form 9, and ReSD tabulation (Listed and Unlisted tabulations).

  • A new radio button is added in the Report Configurations > Scheduling tab to configure the Inclusion Date of the data:

    • For a new report it is set to the Aware Date.

    • For the existing reports prior to upgrade or copied reports is set to the Date Submitted.

      This option cannot be edited for the second time frame report.

  • To include the reaction reported to MHLW directly (cases sent from PMDA or MHLW to MAH):
    • In the Configuration screen, a new option is added to configure Case Classification using the Classification for cases sent by PMDA list box.
    • Filter the cases based on the case classification such that cases are fetched based on the configured classification from the Case Data tables.
    • Eliminate the cases already submitted to PMDA in the ESM.
    • Consider the cases based on Japan information receipt date.
    • Consider the PMDA Reporting criteria applicable for filter logic (Suspected, Serious, excluding un-reportable event)