Setups needed to load clinical data

Here we show how to prepare the platform to handle upload of clinical data in the SDTM format

To handle clinical data in the platform, several setups are needed: 

  1. One setup with the “Clinical domain definition” plugin per domain in your data set, used to define the domain data in "Result Parameters"
  2. One setup with the “Clinical study v2” plugin, used to create the experiment where data is imported

Clinical domain definition setups

Go to the setups page and create a setup with the plugin “Clinical domain definition”.

Navigate to the newly created setup, then to the “Result Parameters” tab. 

Two parameters are required in domain definition setups: DOMAIN and STUDYID. Add these parameters by clicking the “Add from library” button at the top of the Result Parameters table.

The DOMAIN and STUDYID parameters must be constant in a file. Update both the DOMAIN and STUDYID parameters with the “Result Set Constant” Experimental Role.

Once the DOMAIN and STUDYID parameters are defined, you can add the domain specific parameters as described in the Adding parameters section. Domain specific parameters should be “Controlled variable” of type “Text” and named according to the appropriate column in the data file.

Repeat the steps above for each domain in the study.

Clinical study setup

Go to the setups page and create a setup with the plugin “Clinical study v2”.

Navigate to the newly created setup, and check that Parameters and Result Parameters are defined.