Traditionally, the pharmaceutical industry has assessed site performance and addressed site risk using On-site monitoring. This approach is carried out by an individual who visits the trial site at regular intervals, e.g., every four to six weeks to ensure everything is running smoothly.

The approach has relied heavily on significant amounts of SDV is the process of cross-referencing data recorded in a case-report form to the original source informationSource Data Verification (SDV) to provide a certain level of generalized quality control to ensure subject safety and reliable data entry.