SOA Workbench Now Supports Creating Amendments

[pendingintent]

The corresponding USDM JSON class is created as well:

"amendments": [
    {
      "id": "StudyAmendment_1",
      "extensionAttributes": [],
      "notes": [],
      "name": "AMEND_1",
      "label": "Amendment 1",
      "description": "First amendment",
      "number": "1",
      "summary": "Updated inclusion criteria",
      "primaryReason": {
        "id": "StudyAmendmentReason_1",
        "extensionAttributes": [],
        "code": {
          "id": "Code_2525",
          "extensionAttributes": [],
          "code": "IRB/IEC Feedback",
          "codeSystem": "http://www.cdisc.org",
          "codeSystemVersion": "2026-03-27",
          "decode": "IRB/IEC Feedback",
          "instanceType": "Code"
        },
        "otherReason": null,
        "instanceType": "StudyAmendmentReason"
      },
      "secondaryReasons": [
        {
          "id": "StudyAmendmentReason_2",
          "extensionAttributes": [],
          "code": {
            "id": "Code_2526",
            "extensionAttributes": [],
            "code": "OTHER",
            "codeSystem": "http://www.cdisc.org",
            "codeSystemVersion": "2026-03-27",
            "decode": "OTHER",
            "instanceType": "Code"
          },
          "otherReason": "Fix typographical errors",
          "instanceType": "StudyAmendmentReason"
        }
      ],
      "changes": [
        {
          "id": "StudyChange_2",
          "extensionAttributes": [],
          "name": "AMEND_CHG_1",
          "label": "Change 1",
          "description": "Typographical errors lead to ambiguity when interpreting Inclusion Criteria",
          "summary": "Fixed inclusion criteria text",
          "rationale": "Subject safety",
          "changedSections": [
            {
              "id": "DocumentContentReference_2",
              "extensionAttributes": [],
              "sectionNumber": "1.5",
              "sectionTitle": "Header 1.5",
              "appliesToId": "StudyDefinitionDocument_1",
              "instanceType": "DocumentContentReference"
            }
          ],
          "instanceType": "StudyChange"
        }
      ],
      "impacts": [
        {
          "id": "StudyAmendmentImpact_1",
          "extensionAttributes": [],
          "notes": [],
          "type": {
            "id": "Code_2527",
            "extensionAttributes": [],
            "code": "Study Subject Safety",
            "codeSystem": "http://www.cdisc.org",
            "codeSystemVersion": "2026-03-27",
            "decode": "Study Subject Safety",
            "instanceType": "Code"
          },
          "text": "Enhance subject safety",
          "isSubstantial": false,
          "instanceType": "StudyAmendmentImpact"
        }
      ],
      "geographicScopes": [],
      "enrollments": [],
      "dateValues": [],
      "instanceType": "StudyAmendment"
    }
  ]

[pendingintent]

I have not yet implemented geographicScopes, enrollments or dateValues.

[pendingintent]

Shown below is the latest UI design:

The reason for amendment is populated from the response to the CDISC library API, to DDF CT codelist code C207415.

The type for impact is populated from the response to the CDISC library API, to DDF CT codelist code C215481.

[pendingintent]

This information will be used to populate the Impact Analysis report.