Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Changed "clinical trial" to "clinical study" (TOBA-160)

Standardized MedDRA Queries are becoming increasingly common in clinical trial study safety evaluations, particularly when known or suspected safety issues are associated with experimental compounds. In addition, customized queries (CQs) are often used to modify an SMQ or identify records of special interest. The table below lists variables used to identify SMQs and CQs, where zz is replaced with a zero-padded 2-digit integer (01-99) for each SMQ or CQ of interest. This ordering can be based on importance or some other producer-defined criteria. It is recommended that ordering be consistent across studies within a development program, but it is recognized that there may be situations where this is not possible or practical.

...