CSV Output Format

The Seiyakukyo report also supports printing in the CSV format.

  • The Seiyakukyo configuration data is not printed in the CSV format. Only the main Seiyakukyo report output is printed in CSV format.
  • The Report Title is put as the first value in the first row.
  • All the event rows from the report output including the Header row are put in separate rows.
  • The MedDRA J version and Section Footer Text are put as separate rows at the end, in the same way as the report output.
  • Each cell value for a row is put as individual item within that row in the CSV format.
  • All the comma characters and new line characters within a cell value are supported and maintained in the CSV format. It must not break that cell value into multiple items in CSV. This is achieved by using double quote characters for the cell values to escape such characters.
  • All the double quote characters within a cell value are replaced by 2 double-quote characters in the CSV format.
  • All valid Japanese characters as specified for the PMDA E2B file (Main ESM J SRS > 19.6.1 point # 15 (c)) are supported by this CSV format.
  • Different sections related to different case types and Clinical Compound Numbers are separated by a single blank line.