Study Groups

Creation and use of user groups

A group is a category of people who have the same or similar properties. Male and Female can be defined as two groups. Groups can be defined on the basis of Subject or Visit groups. A subject related group could be an age related group and the different groups could have different reference ranges. The use of different reference ranges in different groups is important as the flags created are specific to that group. Elderly subjects should have different reference ranges from younger subjects and the flags created can be different for each group. This allows the subjects to be monitored more accurately.

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Study Groups with groups specific reference range

The LabDriver system uses a global test library which is copied to the study specific test library at the time a new study is setup. All the study specific reference ranges can be edited including the study specific reference ranges for each group.

This screen shot is from the Global Test Library and shows how the test Creatinine Kinase can be setup for different age related reference ranges.

Different Study Groups

LabDriver can distinguish between two different types of groups. Groups can be subject based groups (in the same group for the whole study) or visit based groups (in different groups on different visits). Examples of subject based groups are age groups, eg 18-54 Yrs and 55+ Yrs.

A subject-based group such as age related will not change during the study. 

Examples of visit based groups are fasting, smoking and exercise. In these groups the subjects can be in one group for one visit but a different group for the next visit.

Groups can be configured to use different reference ranges by selecting the R Defines Range on N No Ranges as per the screen shot on the Global Groups Update. All of these details are configurable and would then become study specific.

Automatic Creation of Study Groups

In the Clinical Trials module, groups are configured globally and then copied into the study specific settings during study set up. This allows for the properties of one clinical trial study to be different from another study and could include different reference ranges for that study, the reporting of results in a different number of decimal places etc

Groups that are used very frequently such as age related groups can be configured so that they are automatically added during the study setup process for all studies when they are setup.