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

@article{Bansal2010A2C,
  title={A 21 CFR Part 11 Compliant Graphically Based Electronic System for Clinical Research Documentation},
  author={Ashley Bansal and Richard Chamberlain and Sean Karr and Sassen Kwasa and Bryan McLaughlin and Bao Nguyen and Marc Rendell and Kayla Schmit and Chris Smith},
  journal={Journal of Medical Systems},
  year={2010},
  volume={36},
  pages={1661-1672}
}
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… CONTINUE READING