# JPMA0001 Provided Example - Japanese Language - Clinical Study Protocol v1.0.0-ballot2

## Example ResearchStudy: JPMA0001 Provided Example - Japanese Language

Language: en

Profile: [M11 Research Study Profile](StructureDefinition-m11-research-study-profile.md)

> **M11 Research Study Extension**
* originalProtocol: Protocol Not Amended
* versionDate: 2026-01-14

**Narrative Elements**: [Composition JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria)](Composition-JPMA0001-Section5-jpn.md)

**identifier**: Sponsor Identifier/JPMA001 (use: usual, )

**version**: 2.0

**title**: 経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験

### Labels

| | | |
| :--- | :--- | :--- |
| - | **Type** | **Value** |
| * | Short title | 2型糖尿病患者への投与 |

**status**: Active

**phase**: Phase III Trial

### Recruitments

| | |
| :--- | :--- |
| - | **Eligibility** |
| * | [Group Japanese Protocol from Vulcan UDP Eligibility Criteria](Group-JPMA0001-Criteria-JPN.md) |



## Resource Content

```json
{
  "resourceType" : "ResearchStudy",
  "id" : "JPMA0001-jpn",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"]
  },
  "language" : "en",
  "extension" : [{
    "extension" : [{
      "url" : "originalProtocol",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218485",
          "display" : "Protocol Not Amended"
        }]
      }
    },
    {
      "url" : "versionDate",
      "valueDate" : "2026-01-14"
    }],
    "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
  },
  {
    "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
    "valueReference" : {
      "reference" : "Composition/JPMA0001-Section5-jpn"
    }
  }],
  "identifier" : [{
    "use" : "usual",
    "type" : {
      "text" : "Sponsor Identifier"
    },
    "system" : "https://exemplarSponsor.com/sponsor-identifier",
    "value" : "JPMA001"
  }],
  "version" : "2.0",
  "title" : "経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験",
  "label" : [{
    "type" : {
      "coding" : [{
        "system" : "http://hl7.org/fhir/title-type",
        "code" : "short-title",
        "display" : "Short title"
      }]
    },
    "value" : "2型糖尿病患者への投与"
  }],
  "status" : "active",
  "phase" : {
    "coding" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "code" : "C15602",
      "display" : "Phase III Trial"
    }]
  },
  "recruitment" : {
    "eligibility" : {
      "reference" : "Group/JPMA0001-Criteria-JPN"
    }
  }
}

```
