Since FDA 2304.3 engine was introduced last month, I have started getting a lot of SD1082 issue (Variable length is too long for actual data), while I did not get them with the previous engine (2204.1) when running ADaM validation check. I like to confirm if it is an expected behavior. The variables flagged with SD1082 issues are the standard ADaM variables such as AVALC, SHIFTx, CRITx, PARAM, AVISIT, BASETYPE, PARCATx. Below is an example:
ADLB.CRIT1 has a value ‘>=1 g/dL increase from baseline’ (31 characters), ADEFF.CRIT1 has a value = ‘>=20% Reduction from Baseline in RBC Unit’ (43 characters). In our data, we kept 43 characters for CRIT1 in both ADLB, ADEFF. Now I am getting a SD1082 issue for ADLB for CRIT1 (saying it has 12 excess space), which I didn’t get from the previous engine. We set the length as such based on FDA Study Data Technical Conformance Guide section 3.3.3 (dataset column length). Please advise if this is an intentional change in the recent engine.
Thanks,
Benny.