Data validation is a series of documented tests of the data with the goal of ensuring the quality and integrity of the data.
More specifically, validation is usually concerned with checking four of the eight characteristics of good clinical data – these characteristics are from the first guidance and the first other reference listed below.
Data integrity can also be a performance measure during these operations based on the detected error rate.
Disambiguation: Clinical data validation means checking clinical data for correctness and completeness.
Clinical database validation is making sure that clinical databases perform the functions required by regulations and guidances and is on another page.
As a process, data integrity verifies that data has remained unaltered in transit from creation to reception.
As a state or condition, Data Integrity is a measure of the validity and fidelity of a data object.
Despite this, few regulations talk about data validation directly.