1. PMDA PSR and ReSD Best Practices
  2. PT/LLT Count Level Form-level Configuration Parameter

8 PT/LLT Count Level Form-level Configuration Parameter

A new form-level parameter has been added as PT/LLT Count Level (カウント·レベル), with the following options in PSR Form 3 and ReSD Form 10:

  • Option 1: Case Level (症例レベル) (Default option set in new reports)
  • Option 2: Event Level (症例レベル)
Option 1Option 2

For reports created prior to the upgrade or for copied reports, this parameter is set to Event Level. For new reports, this parameter is set to Case Level. As per the updated guidance, it is recommended to set to case-based counts. If the same PT/LLT code appears in the case/E2B more than once, then the application counts it as one. The infection count that is printed in the ‘()’ also follows the same logic as PT/LLT if the event is marked as Infection for any of the entries.