# Changes - Clinical Study Protocol v1.0.0-ballot2

## Changes

### IG Change History

This provides a list of changes to the IG specification

**2025.08.08 v1.0.0-ballot1 - First Ballot** based on FHIR R6

* Initial version

**2025.04.01 1.0.0-ballot2 - Second Ballot**

* Extensive editorial changes in response to ballot comments
* Revision of mapping spreadsheet to show JSON examples in place of XML examples
* Filled some gaps in coverage of M11 Template in mapping spreadsheet
* Reworked examples including Japanese language example
* Major rework of terminology section to enable terminology validation

