TMRP Webinar: Macey Murray – Data integrity

Trialists must demonstrate to regulatory authorities that all data used in a clinical trial, including healthcare systems data, have integrity and are reliable and complete. Data integrity is defined as the extent to which all data are complete, consistent, accurate, and reliable throughout the data lifecycle. There was little guidance on how to assess and document the integrity of centrally curated healthcare systems data, so in 2021 we co-developed a process. Two NHS Digital data assets were assessed as being “equivalent to a transcribed copy of the original source data” and therefore suitable for use in trials. We then aimed to explore the use and development a metadata cataloguing tool (Collibra) to record the integrity and provenance of datasets within NHS Digital’s data platform in a more automated manner. Macey will present the findings of this work.