After updating the engine and running validation on the define file only, the following issue was raised regarding the dataset label.
In accordance with the SEND IG, we set the label of the CV domain to “Cardiovascular”; however, the issue did not disappear. When we set it to “Cardiovascular Findings,” the issue was resolved.
Would this not be considered a false negative?
Thanks for your question. Even though SENDIG 3.1 and 3.1.1 Table 3.2.1 both show “Cardiovascular” as the “Description” for the CV dataset, these are examples, Pinnacle 21 has chosen the dataset label from the information above the CV domain metadata table in the IGs (p. 162 in SENDIG 3.1 and p. 168 in SENDIG 3.1.1) which matches the “Dataset Label” information in the “Datasets” tab of the CDISC Library downloads of those standards.
As such, we would not consider this to be a false negative result.