Seiyakukyo Line Listing report updates

Summary

Seiyakukyo Line Listing Report updates

Description

Updates to the report configuration

Seiyakukyo Line Listing (SLL) report, also called JPMA (Japan Pharmaceutical Manufacturers Association) report is enhanced to generate based on the study product along with the existing functionality of generating based on the clinical compound number. The report configuration lists the available study products - auto-populated with Study ID, and Product Name of all products configured in the Console > Study Configuration from all study arms including the WHO drugs and J drugs. You can select any study product to generate the SLL report.

In the Regular (Clinical) and Domestic Study Cases section of the line listing report, the cases are included based on submitted expedited or E2B reports that have Sponsor Study Number[C.5.3] (a comparison made only if C.5.3 element is populated in the E2B report) and Drug block[G.k] with Medicinal Product Name[G.k.2.2] that matches with the selected study product in the SLL configuration.

In the Foreign Ichihen Study Cases section of the line listing report, the cases are included based on cases that have study and study product that matches with the selected study product in the SLL configuration.

Updates to the report output

• A new column Product Name is printed.
• The following fields are available for user selection for inclusion in the SLL report when generated in CSV format:
  • Initial Receipt Date (J)
  • Aware date
  • Other References
  • Patient ID
  • Indication PT Term
  • Description as Reported
  • Seriousness Criteria
  • LLT Code
  • PT Code
  • SOC Code
• A new summary table is printed with a list of unlisted and serious adverse events as per the prescribed format by JPMA. Printing of this summary table is optional and is configurable.

  Refer to the Japanese Seiyakukyo Line Listing Report mapping document for details.