Summary

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 Test Reference Ranges within ClinSpark.

Defining Study-specific Reference Ranges with Tests

You can define recommended Reference Ranges for each Test on a per Study basis.

Go to Lab > Configure and add/import Lab Panels to be used in the Study.

Open

Then click Action > Edit for each Test:

Open

Then define the recommended Study-specific Reference Range:

The defined Reference Ranges will be shown in the “Range” column:

Reviewing Reference Ranges in Study > Lab Data

When the Test results come back from the Safety Lab, the Reference Ranges provided by the Laboratory will be displayed in Study > Lab Data > “Reference Range” column. The out of range Alerts will be calculated based on both - the Reference Range provided by the Laboratory and the one added in Labs > Configure.

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.