Ensuring quality data

Defining Quality A typical Phase III clinical trial enrolls, on average, 400 patients – each having 100 or more Case Report Forms (CRFs), which in turn contain approximately 15 data fields each. In short, this represents at least 600,000 opportunities to make an error! The objective of data quality is to ensure that the database of clinical information, from which statisticians reach critical decisions, accurately reflects investigators’ observations, measurements and laboratory test results.