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

## Artifacts Summary

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

### Profiles & Extensions: Base

Base Profiles and Extensions. M11 as part of the name only signifies alignment to M11 - HL7 is the owner

M11_Approval | Approval and sign off
M11_ConfidentialityStatement | Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatement

### Profiles & Extensions: Narrative Structures

Profiles and Extensions to allow representation of narrative structures. M11 as part of the name only signifies alignment to M11 - HL7 is the owner

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.
M11 Research Study Profile | 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 relatesTo attribute.
M11 Research Study Extension | Additions for M11 not otherwise dealt with
Narrative Elements | Narrative content for the ResearchStudy.

### Profiles & Extensions: Protocol amendment

Profiles and Extensions representing amendments to a protocol. M11 as part of the name only signifies alignment to M11 - HL7 is the owner

M11_ProtocolAmendment | Amendment to a protocol. This is originally from EBM.
M11_AmendmentDetails | Provides detail of a single amendment - repeats within the overal amendment report
M11_AmendmentScopeImpact | Provides number or percentage of each group affected by a single amendment

### Terminology: Code Systems

The majority of required code systems are maintained by CDISC on the NCI Thesaurus. The code system here is a fragment to enable terminology validation.

Fragment of NCIT Code System | This is a fragment from the NCI Thesaurus covering codes used by ICH M11 Value Sets. These should all be moved into tx.fhir.org but are included here in FHIR format for testing and validation.

### Terminology: M11 Value Sets

These define sets of codes used by systems conforming to this implementation guide. This list has value sets defined by the M11 Techncial Specification. These are FHIR representations of those value sets. (NOTE ICH and CDISC have a Memorandum of Understanding (MOU) to support the maintenance and governance of ICH M11 controlled terminology ocusing on the use of CDISC’s unified governance process and terminology services for long-term support.)

ICH M11 Amendment Details Statement Value Set Terminology | Terminology associated with whether or not a protocol has been amended. This is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format.
ICH M11 Amendment Scope Enrollment Description Value Set Terminology | Terminology associated with the amendment scope enrollment description value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217275 drawn from the NCI Thesaurus and represented here in FHIR format.
ICH M11 Trial Blinding Role Value Set Terminology | Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217281 drawn from the NCI Thesaurus and represented here in FHIR format.
ICH M11 Study Amendment Country Value Set | Codes drawn from ISO 3166 Country Codes, Alpha 3; ISO 3166 Country Codes, Alpha 2; country/region codes. This is ICH M11 Value Set represented here in FHIR format.
ICH M11 Trial Phase Value Set Terminology | Terminology associated with the trial phase value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217045 drawn from the NCI Thesaurus and represented here in FHIR format.
ICH M11 Reason for Amendment Value Set Terminology | Terminology associated with the reason for amendment value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217276 drawn from the NCI Thesaurus and represented here in FHIR format.
ICH M11 Amendment Scope Value Set Terminology | Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format. The M11 guidance to "leave blank" if not applicable has to be replaced by an explicit "Not Applicable"
ICH M11 No Yes Value Set Terminology | Terminology associated with the no yes value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217046 drawn from the NCI Thesaurus and represented here in FHIR format.

### Terminology: UDP Value Sets

These define sets of codes used by systems conforming to this implementation guide. This list is value sets that are defined by this IG.

UDP Address Purpose Type Value Set | These codes represent intended use of an address. There is an HL7 value set for Contact entity type - this has "prefered" binding and must therefore be included in this value set This is a UDP specific value set using NCIT codes to extend a required HL7 value set. Neither HL7 nor NCIT have the simle concept of a "legal address". HL7 has the concept of an Administrative address which is not precise enough and NCIT has Sponsor Legal Address, Co-SPonsor Legal Address etc For the present we shall use the HL7 ADMIN address as the designation of the legal address.
UDP Identifier Type Value Set | These codes represent the types of identifier used ina study. This is a UDP specific value set. These are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute rather than being a classifier for a more general attribute. FHIR structures are designed to work with a repeating identifier attribute classified by an approriate terminology. This value set enables that by using NCIT codes to create a FHIR value set.
UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | Composition Types to Manage Protocol Narrative Elements. This is a UDP specific value set.
UDP Party Role Type Value Set | These codes represent the types of role ResearchStudy.AssociatedParty can play. This is required for the mechanism used by FHIR for associating one entity with another. This is a UDP specific value set and uses NCIT codes to create an appropriate FHIR value set.
UDP Related Artifact Type Value Set | These codes represent the relationship between an artifact and it related target. There is an HL7 value set for Related Artifact type - this has "extensible" binding. This will be included in this value set. This is a UDP specific value set using NCIT codes to extend a required HL7 value set. The HL7 value set does not have the concept of information that is a summary of an amendment that has been applied. The amends and amended-with concepts talk of content that must be applied to get the final version. M11 only wants to know what has been done - it is more of an amendment trail than an actual amendment. M11 uses a concept from the NCI Thesaurus which is suitable for use here.
UDP Section Codes Value Set | Codes representing sections of M11. This value set is not identified in the M11 specification but is in the NCI Thesaurus and was originally specified for M11. It is NCI Value Set C217272 drawn from the NCI Thesaurus and represented here in FHIR format. These codes are present in UDP to allow granularity in narrative compositions.
UDP Study Title Type Value Set | These codes represent the types of title or name a study can have This is a UDP specific value set using NCIT codes to extend an HL7 value set. These are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute rather than being a classifier for a more general attribute. FHIR structures are designed to work with a repeating attribute classified by an approriate terminology. This value set enables that. Note that the NCI Thesaurus holds separate codes for protocol name (C132300) that are separate from study title (C49802)

### Example Instances: Exemplar Protocol

These examples are a synthetic set of data that aims to exercise as many data points as possible. The protocol described is entierly made up for illustration.

START HERE: Exemplar 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://jghxykgqfk.edge.aidbox.app/ResearchStudy/Exemplar-ResearchStudy-001. This desceribes an entirely ficticious protocol for an imaginary product with Brand name Exotex and generic name Exoticillin produced by Exemplar Pharmaceuticals. The regulator is the Exemplar Regulating Authority (ERA)
Exemplar Protocol Narrative | 1.3 Schedule of Activities and 5.1 Description of Trial Population and Rationale
Exemplar Protocol Narrative 2.1 | 2.1 Purpose of Trial
Exemplar Medicinal Product | Illustration of a MedicinalProductDefinition used by the protocol
Exemplar CoSponsor Organization | A minimal Organization definition
Exemplar Devices Organization | A minimal Organization definition
Exemplar Local Sponsor Organization | A minimal Organization definition
Exemplar Regulating Authority (ERA) | A minimal Regulator definition
Exemplar Sponsor Organization | A minimal Organization definition
Exemplar CoSponsor Practitioner | A minimal Practitioner definition
Exemplar Local Sponsor Practitioner | A minimal Practitioner definition
Exemplar Sponsor Expert Medical Practitioner | A minimal Practitioner definition
Exemplar Sponsor Practitioner | A minimal Practitioner definition
Current amendments details | 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://jghxykgqfk.edge.aidbox.app/ResearchStudy/Exemplar-ResearchStudy-001. This desceribes an entirely ficticious protocol for an imaginary product with Brand name Exotex and generic name Exoticillin produced by Exemplar Pharmaceuticals. The regulator is the Exemplar Regulating Authority (ERA)

### Example Instances: Japanese Protocol

These examples show how the same content can be represented in both English and Japanese. See the Downloads section for a file to load the instance set to a server.

JPMA0001 Inclusion/Exclusion Narrative | Protocol Narrative Sections 5.2 and 5.3
Japanese Protocol from Vulcan UDP Eligibility Criteria | Example showing Janapese text
JPMA Organization | A minimal Organization definition
JPMA0001 Provided Example - English Language | Illustration of a Japanese language protocol - this is the English translation
JPMA0001 Provided Example - Japanese Language | Illustration of a Japanese language protocol - this is the original Japanese

### Example Instances: Narrative - Single Composition

​Illustration of a protocol with narrative as Single Composition. For discussion see section: Narrative Examples

IGBJ Research Study with narrative as Single Composition | Illustration of a protocol with narrative as Single Composition. The same example can also be viewed on the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Narrative-Simple-001.
Example Narrative Single Composition | Example Narrative Single Composition. This illustrates taking the illustration protocol and putting all the content in a single section within a single composition. This is not a recommended pattern.
Narrative Author Organization | A minimal Organization definition

### Example Instances: Narrative - Composition per Section

​Illustration of a protocol with Composition Section for Each M11 Section. For discussion see section: Narrative Examples

IGBJ Research Study with Composition Section for Each M11 Section | Illustration of a protocol with Composition Section for Each M11 Section. The same example can also be viewed on the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Narrative-Section-001.
Example Narrative Composition per M11 Section - Section 1 | Example Narrative Composition per M11 Section. This illustrates taking the illustration protocol and putting each major M11 Section in a composition. This is M11 Section 1. This pattern may be useful when working with part of a protocol.
Example Narrative Composition per M11 Section - Section 2 | Example Narrative Composition per M11 Section. This illustrates taking the illustration protocol and putting each major M11 Section in a composition. This is M11 Section 2. This pattern may be useful when working with part of a protocol.
Example Narrative Composition per M11 Section - Section 3 | Example Narrative Composition per M11 Section. This illustrates taking the illustration protocol and putting each major M11 Section in a composition. This is M11 Section 3. This pattern may be useful when working with part of a protocol.

### Example Instances: Narrative - Section per Section

​Illustration of a protocol with composition for each M11 narrative section. For discussion see section: Narrative Examples

IGBJ Research Study with composition for each M11 narrative section | Illustration of a protocol with composition for each M11 narrative section. The same example can also be viewed on the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001.
Example Narrative Single Composition with a Section for Each M11 Section | Example Narrative Single Composition with a Section for Each M11 Section. This illustrates taking the illustration protocol and putting the content for each section in a section within the same composition. This is probably the most appropriate general purpose pattern.

### Example Instances: Narrative - Complex

​Illustration of a protocol with 1) more granular decomposition of the narrative 2) more complex formatting 3) content that falls outside the M11 template. For discussion see section: Narrative Examples

IGBJ Research Study with complex narrative | Illustration of a protocol with 1) more granular decomposition of the narrative 2) more complex formatting 3) content that falls outside the M11 template. The same example can also be viewed on the server by following this link https://vhewer.com/display-product?url=https://jghxykgqfk.edge.aidbox.app/ResearchStudy/Narrative-Complex-001.
Example Narrative Complex - Other Patterns and Non M11 Content Suggestion | Example Narrative Complex - Custom Content This example shows: 1) more granular decomposition of the narrative 2) more complex formatting 3) content that falls outside the M11 template. These illustrations show what is possible. It is not a recommended way of laying out the protocol. Individual use cases may need other solutions.

### Example Instances: Eligibility Criteria

Structured Representation of Eligbility Criteria

StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial | Simple Eligibility criteria - Age 30-60 years + BMI>=35 + History type 2 diabetes >5y