Regulator-grade data quality, EHRs and outcome assessment in late-phase clinical trials
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A seconded staff member to NHS Digital is looking at the process of data getting from site records into central administrative datasets. This will determine whether these datasets meet the definition of “source data” and, if not, what is the status of these datasets.
Review of applications for routine data complete and the types of trial documented.
Some comparisons of routine and trial-specific data collection (at patient level) completed and systematic review of other examples ongoing.