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FOR REVIEWERS OF ARTICLE: Do we want to point out that defining Ref Ranges on the Site level is possible, but useless, as they are not imported with the Tests into a Study in Lab > Configure?CURRENTLY PENDING CLARIFICATION
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ClinSpark takes a conservative approach to Lab reported Safety concerns, ensuring that we always display Alerts and Values based upon what the Lab reports. Lab results are also frequently reviewed by PIs. There can however be challenges in managing what acceptable ranges are for certain test results in specific Study context, outside of the results that are always reported by the Labs standard safety range.
There may also be scenarios where a certain range is acceptable at Study start, but difficulty in tracking results from baseline through dosing and other events until Study close. Certain results would fall into a range that would be flagged/identified for additional follow up and review. It may be necessary to trigger Adverse Events based upon those results meeting this Study specific Reference Range requirements.
This article provides the information about configuring and using Laboratory Test Reference Ranges within ClinSpark.
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If the Study-specific Reference Ranges were defined in Lab > Configure (as described above), then you will be able to view the Ref Ranges defined within ClinSpark side by side with the Ref Ranges defined by the Lab.
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