Article | September 16, 2022

Automate Your Collection Of Lab Reference Ranges

Source: OpenClinica
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Data managers invest a lot of time and attention documenting lab processes, and for good reasons. Regulatory compliance demands it. Also, ensuring the validity and clinical significance of lab results is critical to assessing safety and efficacy. But while necessary, this process is often inefficient and error-prone.

In an ideal clinical study, every lab sample would, within minutes of collection, find its way to a central lab whose equipment was forever up-to-date, whose validations were always fresh, and whose inner workings were transparent to the data manager. But clinical trials aren’t conducted in an ideal world. More often than not, data managers and local lab managers share an ongoing responsibility to document equipment features and report on results collected on a variety of instruments, all calibrated differently. The challenges associated with this process are familiar. Equipment changes. Validations expire. And one lab’s “normal” may be another lab’s “low.”

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