Labs can be collected for either manual entry or via bulk import. Either way, the lab values entered on subject CRFs can be checked automatically by the system and subsequently flagged as out of range for further evaluation by a Clinician. A pre-determined measurement unit can also be auto-populated by the system.
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Use a dropdown field for the site to identify which lab was used, but do not create any choices within it. The lab sites are related to the study sites later on during setup in the within the Site Document Manager. The lab sites specified there will be what ends up populating these choices for the user entering data.
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Labs sites and study sites are associated with and set up in the Site Document Manager The corresponding permission must also be enabled as discussed in https://crucialdatasolutions.atlassian.net/wiki/pages/resumedraft.action?draftId=55312481.Documents. The ability to map labs to sites requires the appropriate permission.
In the image below, you can see there are five study sites. The first three study sites have 1 or 2 lab sites associated. In this example, we need to associate the fourth study site with a couple of different labs. To do so, select the link highlighted in the image.
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If the Lab ranges are not checked, it is likely due to missing variables collected on another form needed for the range checks. A common example is Age and Gender collected on the Demographics form. Since lab ranges often depend on the subject’s age and gender, those are needed before the range checking can occur. |
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