Validator 1.3 flags SDTM 3.1.2 Amendment 1 Variables as Invalid

Pinnacle 21 Support SDTM
1

Hi Walter, 1. What are the variables which trigger SD0058 check? In our test cases there are no issues with new Amend 1 variables. We need more information to explore if this is a real issue. 2. Thanks for reported bug. It should not have any relation to SD0058 rule execution though. However the check SD0057 will ignore new MedDRA coding variables as Expected ones. We fixed this. The new corrected files will be variable on soon (about one hour after my post). http://svn.opencdisc.org/validator/trunk/config/config-sdtm-3.1.2-amend-1.xml http://svn.opencdisc.org/validator/trunk/config/data/SDTM%20Metadata%203.1.2%20Amend%201.csv

Best Regards, Sergiy

2

Curious as to if/how the FDA gets the same maintenance updates? How about regular non-paying users like us?

3

No, those are non-official (“under development”) files. FDA does not (and cannot) use them until an official release.

4

SDTM 3.1.2 Amendment 1 variables are still being flagged as invalid, as per rule SD0058. What could the problem be?

Secondly, the new MedDRA variables in the SDTM Metadata 3.1.2 Amend 1.csv do not have values in the Core column. Could this cause problems in the verification of compliance to some other rules such as SD0057?