Approval and sign off

Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatement

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.

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.

Additions for M11 not otherwise dealt with

Narrative content for the ResearchStudy.

Amendment to a protocol. This is originally from EBM.

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

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

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 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.

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.

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.

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.

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.

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.

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"

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.

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.

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.

Composition Types to Manage Protocol Narrative Elements. This is a UDP specific 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.

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.

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.

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)

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)

1.3 Schedule of Activities and 5.1 Description of Trial Population and Rationale

2.1 Purpose of Trial

Illustration of a MedicinalProductDefinition used by the protocol

A minimal Organization definition

A minimal Organization definition

A minimal Organization definition

A minimal Regulator definition

A minimal Organization definition

A minimal Practitioner definition

A minimal Practitioner definition

A minimal Practitioner definition

A minimal Practitioner definition

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)

Protocol Narrative Sections 5.2 and 5.3

Example showing Janapese text

A minimal Organization definition

Illustration of a Japanese language protocol - this is the English translation

Illustration of a Japanese language protocol - this is the original Japanese

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. 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.

A minimal Organization definition

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. 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. 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. 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.

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. 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.

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 - 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.

Simple Eligibility criteria - Age 30-60 years + BMI>=35 + History type 2 diabetes >5y