White paper: Data Consistency and Quality Issues in SEND Datasets
PointCross has reviewed numerous SEND datasets prepared for test submissions to the FDA and has worked with the FDA on their KickStart program to ensure that received datasets are suitable for pharm/tox review. What we are observing is that creating a dataset that is technically compliant (i.e., one that passes the validation rules) is a low bar – it is necessary, but not sufficient to meet FDA review requirements.
In our experience, sponsors and CROs are having a much more difficult time ensuring that SEND datasets have no data quality issues that impact “fitness for review”. We have routinely observed cases where SEND datasets are inconsistent with the accompanying study report and have insufficient data for pharm/tox review despite the fact that these data often have been collected and tabulated in the study report.