This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot2: STU 1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

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