Clinical Study Protocol
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Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Example ResearchStudy: Current amendments details

Page standards status: Informative

Language: en

Profile: M11 Research Study Profile

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: 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)
  • signatureUrl: https://somelocation
  • signatureMethod: electronic and wet ink copy

M11_ProtocolAmendment

url

identifier

value: Amendment Identifier/ABC-Exemplar(a)

url

previous

value: Protocol Previously Amended See Summary of Changes Before the Table of Contents

url

scope

value: Not Global

url

Country ValueSet

value: Germany

url

Country ValueSet

value: United Kingdom of Great Britain and Northern Ireland

url

region

value: New South Wales

url

site

value: https://example.org/site-identifier/exemplarSite-14

scope: Locally

number: 234

url

M11_AmendmentScopeImpact

scope: Global

number: 983

url

M11_AmendmentScopeImpact

url

primaryReason

value: Regulatory Agency Request to Amend Amendment Reason

url

secondaryReason

value: Manufacturing Change Amendment Reason

url

secondaryReason

value: Packaging revision

url

summary

value: Manufacturing chanage to enable packaging change to recyclable materials.

url

substantialImpactSafety

value: Yes

url

substantialImpactSafetyComment

value: Specifically implemented to decrease safety risks.

url

substantialImpactReliability

value: No

detail: Clarification

rationale: Clarification of synopsis at request of regulator

section: ICH M11 Protocol Section 1.1 Protocol Synopsis

url

M11_AmendmentDetails

detail: Exclusion change

rationale: Exclude regular drinkers at request of regulator

section: ICH M11 Protocol Section 5.3 Exclusion Criteria

url

M11_AmendmentDetails

detail: Packaging change

rationale: Change to recyclable packaging (stated in proprietary name).

section: ICH M11 Protocol Section Title Page

url

M11_AmendmentDetails

url

description

value:

#Protocol ABC-Exemplar A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus has been amended. The new protocol is indicated by Amendment (a) and will be used to conduct the study in place of any preceding version of the protocol. The overall changes and rationale for the changes made to this protocol are as follows: - An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. - The Intravenous Exoticillin GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015).

identifier: Sponsor Protocol Identifier/ABC-Exemplar (use: usual, )

version: (a)

status: Active