Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

@article{Huser2015StandardizingDE,
  title={Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)},
  author={Vojtech Huser and Chandan Sastry and Matthew Breymaier and Asma Idriss and James J. Cimino},
  journal={Journal of biomedical informatics},
  year={2015},
  volume={57},
  pages={
          88-99
        }
}
Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in… CONTINUE READING
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