Just released by CDISC: the SDTM Amendment 1.
The amendment was created by a number of CDISC volunteers in cooperation with CDER (FDA) - other departments seem to have not been involved.
It adds a new set of variables (MedDRA codes and decodes) to the Events classes and also some new variables to the Demographics domain. Also the AE domain is extended with the new "MedDRA" variables, so that each row in the AE now has 51 (!) fields.
Fortunately, the changes and additions are not very extensive nor complicated, so that I could implement everything in our SDTM-ETL software package in just two evenings.
However, the SDTM Amenment 1 also raises a lot of new questions like:
- what about submissions that do not go to CDER (but e.g. to CBER): are the new set of rules also applicable in that case?
- or is the Amendment 1 a "CDER dialect" of the standard?
- other departments than CDER seem not to have been involved. Do they agree on these additions and changes? Were they asked at all?
- why isn't this a new version of the standard. Amendments to "final" (?!) standards are always dangerous.
- MedDRA codes need to be provided as numeric values. Now these codes are 8 characters long. Can SAS XPT cope with such very high numbers? I have some doubts.
- how do I deal with this new "standard" in define.xml? The latter is not even mentioned in the document!
- what do I need to fill in for def:StandardVersion in define.xml? Most software packages use that attribute for finding out which version of the standard was used.
and many many more ...