Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Changes

Page standards status: Informative | Highlight text 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

  - Negative comments

  - Item | Comment | Status | Disposition
    --- | --- | --- | ---
    BALLOT-84099 | One Composition per section? | Applied | Not Persuasive with Modification
    BALLOT-84099 | No Must Support or Obligations | Applied | Persuasive
    BALLOT-84099 | Target R4 and use extensions | Resolved - No Change | Not Persuasive
    BALLOT-85419 | Use case representation in figure 2 | Applied | Persuasive

  - There were a further 43 affirmative comments. Full ballot results are here

- 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