A Standard-driven Approach for Electronic Submission to Pharmaceutical Regulatory Authorities

Conclusion This standard-driven approach accelerated CRF annotation and assured data tabulation integrity. The benefits of this approach include an improvement in the use of standards during the clinical trial and a reduction in missing and unexpected data during tabulation. The standard-driven approach is an advanced design idea that can be used for future clinical information system development. Graphical abstract
Source: Journal of Biomedical Informatics - Category: Information Technology Source Type: research