1. PMDA PSR and ReSD Best Practices
  2. Listedness Assessment on Report-level Configuration Parameter

6 Listedness Assessment on Report-level Configuration Parameter

A new report-level parameter has been added as Listedness Assessed on (既知/未知評価) for configuring the assessment parameter for the reaction, with the following options:

  • Option 1: Case Assessment (症例の評価) (Default option set in new reports)
  • Option 2: Datasheet (データシート)
Listed Assessed on parameter

The Listedness Assessment Source for PSR and ReSD common profile switch is marked as deprecated.

PSR and ReSD reports considering this common profile switch will henceforth consider the new report-level configuration for newly created reports or for copied reports.

For reports created prior to the 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.

It is recommended to set this option for every report configuration as per the business process.