Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

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

## Example ResearchStudy: START HERE: Exemplar Research Study with narrative

Page standards status: Informative

Language: en

Profile: M11 Research Study Profile

M11_ConfidentialityStatement: All data is confidential

> M11 Research Study Extension

> - originalProtocol: Protocol Previously Amended See Summary of Changes Before the Table of Contents
> - versionDate: 2017-10-01

> M11_Approval

> - approvalDate: 2017-10-05
> - signature: No display for Signature (data: )
> - signatureUrl: https://somelocation
> - signatureMethod: electronic and wet ink copy

Narrative Elements: Composition Exemplar Protocol Narratives

Narrative Elements: Composition Exemplar Protocol Narrative 2.1

identifier: Sponsor Protocol Identifier/ABC-Exemplar, EU CT Number/EU-1234, Other Regulatory or Clinical Trial Identifier/ERA1234, Amendment Identifier/ABC-Exemplar(a)

version: (a)

title: A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus

> label

> type: Study Acronym

> value: Inhaled vs IM Exoticillin

> label

> type: Brief Study Title

> value: A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients

### RelatesTos

- | Type | Target[x]
* | Justification | ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar (use: usual, ); version = (a); status = active

status: Active

phase: Phase III Trial

### Focus

- | Reference
* | MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03

condition: Iatrogenic hypoglycaemia

> associatedParty

> role: Clinical Study Sponsor

> party: Organization Exemplar Pharmaceuticals Co.

> associatedParty

> role: Clinical Study Sponsor

> party: Practitioner Dr Exemplar Practitioner

> associatedParty

> role: Study Co-Sponsor

> party: Organization Exemplar Pharmazeutika GmBH.

> associatedParty

> role: Study Co-Sponsor

> party: Practitioner Dr Exemplar von Practitioner

> associatedParty

> role: Local Legal Sponsor

> party: Organization Fictive Pharmaceuticals (Australia) Pty

> associatedParty

> role: Local Legal Sponsor

> party: Practitioner Bruce Exemplar

> associatedParty

> role: Device Manufacturer

> party: Organization Exemplar Devices Ltd

> associatedParty

> role: Sponsor Medical Expert

> party: Practitioner Dr Exemplar Consultant