The Long Road to eSource

Streamlining clinical research, particularly data acquisition, through the use of technology dates back to the 1990s with ‘remote data entry’, which was quickly renamed ‘electronic data capture’ (EDC) to reflect that data were being entered at investigative sites that were not ‘remote’, but rather the actual source of the data. While EDC technologies slowly gained traction, regulators were faced with the challenge of translating regulations written for paper-based processes to the new world of EDC. ‘The Final Rule for FDA Title 21, CFR Part 11: Electronic Records; Electronic Signatures’ was released in 1997 and generated numerous industry presentations, scenarios, and discussions related to the implementation of this regulation (1). Topics addressed included detailed analyses of aspects such as the source of the data, who had control of the data at a given point in the process, closed vs open systems, validation requirements, and change control procedures to maintain an audit trail. The FDA had authority to inspect these systems, and they needed to develop methods and training so that auditors could review electronic audit trails and validation documents.