PhUSE CSS 2020 Poster
September 21 – 23, 2020
A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review
PointCross presented and was awarded Best Poster in the Industry category for our poster, A Process for Automated Reconciliation of SEND Datasets with Study Reports for Confident Submission and Review.
SEND datasets and study reports are created by different processes, with study reports having predefined groupings, terminologies, and reporting conventions. In our opinion, regulatory reviewers trust reports because they fall under GLPs, are audited by QA, and signed by the Study Director. To reconcile SEND datasets against study reports, we propose a process in which study report tables are converted to a machine-readable columnar format that includes all summary tabulations and subject level listings. 100% automated reconciliation of tables in study reports with regenerated summaries from SEND is then possible. Automated “reconcilers” can use semantic enrichment for controlled terminologies and compare mapping between predefined cohorts in the study report to those in the SEND trial design. We propose that this model will demonstrate to reviewers that SEND datasets accurately represent data in study reports.
“The poster provided great insight into the reconciliation process of SEND datasets with the existing Study Report. The authors demonstrated the use of automated “reconcilers” to read existing study reports in machine-readable columnar format and compare it with the retrospectively generated SEND datasets. They were able to lay out the process to demonstrate to the reviewers that the SEND datasets accurately represent data in the study reports. This poster will provide a great reference to the industry looking to make advancement in this topic.” – PhUSE panel of judges.