A Brief Overview Of The Quality Checking Process

By Marshalle Grody, Quality Checking and eCTD Submission Associate

The research is done, the writing is complete, and every word in the project has been scrutinized dozens, sometimes hundreds, of times over. After so much collective effort, this must surely be the best version, right? Unfortunately, even though the study team strives to maintain quality throughout every step of clinical studies, research documents must also be inspected for accuracy and integrity towards the end of the process in order to prepare them for submission to regulatory authorities. The careful eyes of a Quality Checking (QC) expert are required to notice and correct errors that might otherwise render all the writer’s and researchers’ work unpublishable.