Enhancing Traceability in Clinical Research Data Through an Information Product Framework

@inproceedings{Hume2017EnhancingTI,
  title={Enhancing Traceability in Clinical Research Data Through an Information Product Framework},
  author={Samuel J. Hume},
  year={2017}
}
Data quality is foundational to clinical research and each process through which the data passes must be documented such that the published tables and listings can be traced back to the original, raw data (Nahm, 2012). In regulated clinical research, traceability is a requirement and indicates that the content of the clinical study report can be traced back to the original source data. Today’s clinical research solutions have significant traceability limitations. This design science research… CONTINUE READING

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