Summary

ClinSpark supports the ability to produce a CDISC ODM XML study design file. This design export is essentially a ‘light’ framework of various CRF design elements that otherwise would be encompassed on a much more robust ClinSpark study design export (.studydesign file).

Open

Open

Using the ODM XML design file can be advantageous to customers who want to quickly take very basic CRF design elements from one environment and import them into another environment.

CRF Design Elements in ODM XML

The ODM XML file produced from a ‘source’ study will contain all of the structure (and most of the properties) of Study Events, Forms, Item Groups, Items, Code Lists, Measurement Units, Methods, and Edit Checks.

Limitations

However there are a number of properties which will not be included by this file from ‘source’ and will need to be re-established in any ‘target’ environments after import.

The following is an inclusive list of omitted study design elements:

• Common Form Setting

• Barcode Requirements

• Visibility Conditions

• Role Restrictions

• Capture Time Setting

• Disallow Future Date Setting

• Default Item Groupings

• Base Types

• Device Connectivity

• Volunteer Integration Connectivity

• Sample Paths

• Lab Panels

• Soft/Hard Upper and Lower Ranges (these instead get translated into explicit edit checks during importation)