A 21 CFR Part 11 Compliant Graphically Based Electronic System for Clinical Research Documentation

Abstract

Clinical research protocols are intricate and detailed. Regulatory authorities including the U.S. Food and Drug Administration require full documentation of all procedures, including who performed them and when they were performed. Paper based study records are becoming ever more voluminous as the requirements for detailing every item continue to grow. Although the current approach is to transfer required data to electronic databases, each protocol requires uniquely designed databases. Therefore, at present, it has not been possible to design generalized electronic databases which serve for each individual study which can serve as primary source documentation. We have taken a new approach, by developing an electronic graphically based source documentation technology which in every way mimics and maintains the advantages of paper recordkeeping. We use tablet computers as paper surrogates, feeding data archives maintained on central servers. Our system uses widely available non-proprietary components and programs. We meet the requirements enunciated by the US Food and Drug Administration for electronic systems. These include requirements to maintain data integrity, backup of data, validation of all system components, safeguards on digital signatures, and a date and time stamped audit trail. This system has been used by our group successfully for more than 2 years encompassing over 20 pharmaceutical research studies.