j Jassi
on

 

As per FDA study technical conformance guide:

3.3.3 Dataset Column Length

The allotted length for each column containing character (text) data should be set to the maximum length of the variable used across all datasets in the study except for suppqual datasets. For suppqual datasets, the allotted length for each column containing character (text) data should be set to the maximum length of the variable used in the individual dataset.

Validation Rule FDAC0036 checks data within each dataset prior to adjusting it's length. Any idea when will Pinnacle update the rule as per Study technical conformance guide rule.

 

Thanks

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