Clinical-Data Acceptance Testing Procedure

Abstract

AbstractWith the recent news from FDA to push tighter safety reviews due to increased patient deaths caused by Viox, pharmaceutical companies need to develop systems for early detection of safety and clinical data issues. In the pharmaceutical industry, there is a regulatory responsibility, 21 CFR Part 11, to analyze only the clinical data that have passed data acceptance testing or is considered 'clean data' after a database lock. Clinical data acceptance testing procedure involves confirming the validity of critical data variables as well as early identification of health risk issues. These critical data variables might need to be non-missing, consist only of valid values, be within a range, or be consistent with other variables. If incorrect clinical data are analyzed, then invalid study conclusions can be drawn about the drug's safety and efficacy.