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

PSR Form 3 (Tables)

  • In addition to the existing configurations, it has been enhanced as listed below:
    • 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 time frame where the case was last reported.
    • Case classification is configured in the Classification for cases sent by PMDA list box.
    • Data inclusion parameter is set to Aware Date or Date Submitted.
    • A report-level configurable option is added to print case count or event count for the PT/LLTs based on the report configuration.
    • If Case level count is selected, and if same PT/LLT code appears in the case or E2B more than once, then the application counts the code only once.
    • When the application is configured for the Case Counts of PT/LLT, then an option is provided to count Count Listed & Unlisted as two separate events.
  • In addition to the existing data inclusion logic, it has been enhanced as below:
    • If the profile switch Event counting logic for P.S.R Form 3, 4 and ReSD Form 10, 11 is set to Count each event from a case with the timeframe where the case was reported last, then the application prints the events from the latest submitted E2B report for the latest time frame where it was reported across all the time frames for which report is executed.
    • If Count Listed and Unlisted are checked as two separate events, and later the same reaction is marked as Listed for one entry in the case and Unlisted for the other entry, then the event is counted as two separate events.
    • If Count Listed and Unlisted are unchecked, and later the same reaction is marked as Listed for one entry in the case and Unlisted for the other entry, then the event is counted as Unlisted event.
    • The Event Count logic is updated for case count or event count. The same is applicable for infection count.
    • Cases received by MAH from PMDA or MHLW and entered into the system, are included based on the inclusion criteria and configured case classifications.