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

## Example ResearchStudy: JPMA0001 Provided Example - English 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

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

**version**: 2.0

**title**: A Multicenter, 52-week, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Co-administration of JPMA001 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Treated With Oral Hypoglycemic Drugs as a Single Agent

### Labels

| | | |
| :--- | :--- | :--- |
| - | **Type** | **Value** |
| * | Short title | Administration for patients with type 2 diabetes |

**date**: 2026-01-14

**status**: Active

**phase**: Phase III Trial



## Resource Content

```json
{
  "resourceType" : "ResearchStudy",
  "id" : "JPMA0001-eng",
  "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"
  }],
  "identifier" : [{
    "use" : "usual",
    "type" : {
      "text" : "Sponsor Identifier"
    },
    "system" : "https://exemplarSponsor.com/sponsor-identifier",
    "value" : "JPMA001"
  }],
  "version" : "2.0",
  "title" : "A Multicenter, 52-week, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Co-administration of JPMA001 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Treated With Oral Hypoglycemic Drugs as a Single Agent",
  "label" : [{
    "type" : {
      "coding" : [{
        "system" : "http://hl7.org/fhir/title-type",
        "code" : "short-title",
        "display" : "Short title"
      }]
    },
    "value" : "Administration for patients with type 2 diabetes"
  }],
  "date" : "2026-01-14",
  "status" : "active",
  "phase" : {
    "coding" : [{
      "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "code" : "C15602",
      "display" : "Phase III Trial"
    }]
  }
}

```
