Risk Based Approach In Data Management

Data quality within the clinical research enterprise can be defined as the absence of errors that matter and assurance that the data is good enough to fit the purpose.

Source document verification (SDV) is commonly used as a quality control method in clinical research. It is disproportionately expensive and often leads to questionable benefits. Its efficiency was found to be low in several studies.

Mitchel et al. analyzed the impact of SDV and queries in a study utilizing direct data entry at the time of the clinic visit. The results showed that only 3.9% of forms were queried by clinical research associates and only 1.4% of forms had database changes as a result of queries.