PMDA Event Reportability Updates

• The following field values from the PMDA Event Reportability Print section are available/stored in database tables/columns so that they can also be queried for other custom reporting needs:
  • Reportability Status - Reportable, NUPR Reportable, Not-Reportable
  • Reportability Timeframe value in days
• To avoid unwanted performance impact on Case Save action, these field values should not be calculated on each case save. These are calculated based on only the following actions:
  • Manual method - "Recalculate PMDA Event Reportability" button

    A new button "Recalculate PMDA Reportability" has been added to Case Form > Analysis > PMDA Info > General tab > Product License section header bar right before the "Up" and "Down" buttons.

    Clicking on this button triggers the fresh calculation of the PMDA Event Reportability data.

    This button is not displayed when the user opens a previous case revision in the Case Form.

  • Automatic method - Case Lock action

    A new common profile switch has been added in Console > System Configuration > System Management > Argus J > Reporting as described below:

    Key Label: Perform PMDA Event Reportability calculation on each Case Lock

    Key Type: Radio Options

    Key Options: "Yes" and "No"

    Default Value: "No"

    If this common profile switch is set to "Yes", then when the case is locked from any point in Argus Safety application, it triggers the fresh calculation of the PMDA Event Reportability data.

• The following is implemented during the PMDA Event Reportability calculation process:
  • While these values are being calculated by application, a standard processing icon is displayed on the case form.
  • If any unsaved changes are done by the user in the case data before clicking this button, then all those changes are considered and saved during the calculation process.
  • Once the calculations have been completed, the calculated values are saved in the appropriate database tables, along with the case revision data.
  • After successful completion, a standard Argus Safety message box is displayed with OK button and message - "PMDA Event Reportability data has been successfully calculated and saved with the case data for the current case revision." This is applicable only for "Recalculate PMDA Event Reportability" button click and not for Case Lock action.
• For the latest case revision, these field values are available in regular Argus Safety database case form tables.
• For previous case revisions, the field values are available in the DLP database case form history data tables.
• For the case revisions, for which PMDA Event Reportability data is not calculated, it is carried-over from its previous case revision for the case form / DLP database tables as well as for displaying it in the Case Print.
• Case Form Print > PMDA Event Reportability section > Reportability column > Reportability Status and Timeframe value is calculated / printed based on the reporting rules that existed at the calculation point.
• Other fields which are displayed as part of Case Form Print > PMDA Event Reportability section for each case revision are not required to be saved in database tables, but are calculated / printed along with the reportability fields in the Print PDF for that case revision.
• Following field values in Case Form Print > PMDA Event Reportability section are also calculated / printed based on the Console configurations that existed at the calculation point.
  • Outline of Clinical Trials (J.12 section)
  • Listedness As per Datasheet (based on the active datasheet as that point)
• The following note is printed at the bottom of PMDA Event Reportability section print - "# PMDA Event Reportability last calculated on case revision # <XXX> at <YYYY/MM/DD HH:mm:ss> JST", where:
  • <XXX> is the case revision number as displayed in case revisions dialog for which the PMDA reportability was calculated.
  • at <YYYY/MM/DD HH:mm:ss> is the time when it was last calculated as per the Japan standard time. It is calculated based in the common profile switch Argus J > Reporting > "Offset from GMT used to calculate Japanese date/time fields (in hours)"
• For existing/migrated cases, the data displayed as part of Case Form Print > PMDA Event Reportability section will not be available for previous or latest case revisions. It will be created going forward as those cases are saved by users in Argus Safety application.
• No audit log is required for these values calculated and stored in database as these as internally calculated values and no updates are allowed from any user interface.
• This PMDA Reportability data is not copied during Case Copy action.
• While calculating the earliest timeframe value for PMDA Event Reportability section, existing application logic considers only those matching reporting rules for which the reporting destination is configured as below to identify if it is a PMDA or non-PMDA reporting rule:
  • Reporting Destination > Agency Type field is specified as Regulatory Authority and
  • Reporting Destination > Agency Country field is specified as Japan.