About Data Audits
CCASAnet has instituted a process of periodic data monitoring visits at its member sites, using audit principles adapted from the International Congress on Harmonization “Good Clinical Practice” E6 guideline. During a CCASAnet data audit, researchers from the Coordinating Center visit a CCASAnet site and compare the datasets that sites have submitted for studies to the clinical care source documents (often paper medical records.)
These on-site audits help the Coordinating Center assess the accuracy and completeness of study data submitted for ongoing research projects, identify hidden data biases, and design interventions that sites can use to improve data management practices. Network-wide audits also help to establish trust among sites regarding the quality of data used for merged analyses.
In the second year of CCASAnet, we shared a document describing our audit process with our parent network, IeDEA: CCASAnet Audit Process. It has since been adopted and adapted by other IeDEA members.
Error Coding
