Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

Artifacts Summary

Contents:

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

M11 Research Study

Constraint of ResearchStudy to M11 Guidance An instance of this profile represents a single version of the protocol definition. Previous amendments are represented by further instances of ResearchStudy linked through the relatedArtifact attribute.
Research Study Narratives

Narrative elements associated with a research study following the ICH M11 CeSHarP template. The ICH M11 CeSHarP template for a study protocol specifies the headings to be used to organize protocol content. For a FHIR representation of the protocol to be compliant with this template each of the narrative sections must be organized using these headings. Only if there is material that does not properly belong under one of the M11 headings can additional codes be created.
StudyDesign

Profile of ResearchStudy for Evidence Based Medicine IG. The StudyDesign Profile is used to add extensions for additional expressions of study design features with the protocol.

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

M11_ProtocolAmendment

Amendment to a protocol. This is originally from EBM.
Narrative Elements

Narrative content for the ResearchStudy.
ResearchStudyStudyAmendmentDetails

Provides detail of a single amendment - repeats within the overal amendment report
ResearchStudyStudyAmendmentScopeImpact

Provides number or percentage of each group affected by a single amendment

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

CDISC DDF Study Title Type Value Set

Codes drawn from NCI Thesaurus value set $NCIT#C207419 CDISC DDF Study Title Type Value Set Terminology These codes represent the types of title or name a study can have according to CDISC DDF
CDISC Yes No Unknown Not Applicable Value Set

Contains all values from C66742 - CDISC SDTM Yes No Unknown or Not Applicable Response Terminology
M11 Identifier Type Value Set

Identification of the type of identifier.
M11 Phase Value Set

Codes drawn from NCI Thesaurus value set $NCIT#C217045 ICH M11 Trial Phase Value Set Terminology These codes represent phases of a study as defined by ICH.
M11 Section Codes Value Set

Codes representing sections of M11.
NCI Study Role Value Set

Codes drawn from NCI Thesaurus as children of $NCIT#C48355 Sponsor These codes represent the roles an individual or an organization can play in a study. There is a value set $NCIT#C215480 - CDISC DDF Study Role Code Value Set Terminology but it does not have any members.
Narrative Elements Value Set

Composition Types to Manage Protocol Narrative Elements
Study Amendment Country Value Set

Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; GENC country affected by an amendment to a study.
Study Amendment Reason Value Set

Codes drawn from NCI Thesaurus to represent the reasons a study was amended.
Study Amendment Scope Enrollment Value Set

Categorizing numbers affected by the amendment
Study Amendment Scope Value Set

Codes drawn from NCI Thesaurus to represent the scope of an amendment to a study.

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Narrative Elements Code System

Composition Types to Manage Protocol Narrative Elements

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

IGBJ Medicinal Product

Illustration of a MedicinalProductDefinition used by the protocol
IGBJ Organization

A minimal Organization definition
IGBJ Protocol Narrative 1.3 - Schedule of Activities

1.3 Schedule of Activities
IGBJ Protocol Narrative 2.1

2.1 Purpose of Trial
IGBJ Protocol Narrative 5.1

5.1 Description of Trial Population and Rationale
IGBJ Protocol Narrative 9

9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION
IGBJ Research Study with narrative

Illustration of a protocol with some parts in narrative form and some in granular form. The same example can also be viewed on the server by following this link https://vhewer.com/display-product?url=https://fs-01.azurewebsites.net/Bundle/ICH-M11-Template-IGBJ-Bundle