Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

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

Changes

Page standards status: Informative

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