MedDRA (multiple versions)

Pinnacle 21 Support Define.xml
1

Hi,

It is understood that within the define.xml the MedDRA version is indicated, in which, OpenCDISC will validate against (if the user has a licensed MedDRA dictionary present). Additionally, it is understood that MedDRA parameters would reside within a .csv, which would be identified as AEDECOD.csv. However, as a services company, we would like to utilize multiple versions of MedDRA by using a single source (i.e. AEDECOD.csv). Therefore, here are a couple questions in regards to MedDRA validation:

  1. Can the AEDECOD reference file be utilized as another extension source (e.g. .txt or .sas7bdat) instead of .csv?

  2. What parameters/variables (from the MedDRA source) must be included in the above documentation? For instance, should the full list remain intact, as MedDRA produced, for validation efforts? Otherwise, can a user only utilize the necessary parameters/variables for validation?

Additional Details:
SDTM 3.1.2
OpenCDISC 1.2.1
MedDRA (all versions up to 14)
Valid define.xml utilized

Thanks