Generated Narrative: StructureDefinition m11-report-section-06 Name Flags Card. Type Description & Constraints Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation #xD; type #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://loinc.org #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: 35528-9 #xD; display 1..1 string Representation defined by the system Fixed Value: Clinical trial protocol Clinical trial protocol #xD; text 0..1 string Plain text representation of the concept Required Pattern: CeSHarP Report #xD; Slices for category 0..* CodeableConcept Categorization of Composition Slice: Unordered, Open by value:text #xD; category:intervention 0..1 CodeableConcept Categorization of Composition #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218560 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6-trial-intervention #xD; Slices for section 1..1 BackboneElement Composition is broken into sections Slice: Unordered, Open by value:code.text #xD; section:intervention S 1..1 BackboneElement Composition is broken into sections #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218560 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6-trial-intervention #xD; text 0..1 Narrative Text summary of the section, for human interpretation #xD; Slices for section 10..* Nested Section Slice: Unordered, Open by value:code.text #xD; section:description S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.1 Description of Investigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218561 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.1-description-of-trial-intervention #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; entry 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section #xD; section:rationale S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.2 Rationale for Investigational Trial Intervention Dose and Regimen #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218562 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.2-rationale-for-trial-intervention-regimen #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; entry 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section #xD; section:dosingAdministration S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.3 Investigational Trial Intervention Administration #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218563 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.3-dosing-and-administration #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; entry 0..* Reference(ActivityDefinition) A reference to data that supports this section #xD; section:doseModification S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.4 Investigational Trial Intervention Dose Modification #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218564 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.4-dose-modification #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; entry 0..* Reference(ActivityDefinition) A reference to data that supports this section #xD; section:treatmentOfOverdose S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.5 Management of Investigational Trial Intervention Overdose #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218565 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.5-management-of-overdose #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; entry 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section #xD; section:preparation S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218566 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.6-preparation-storage-handling #xD; text 0..1 Narrative Text summary of the section, for human interpretation #xD; Slices for section 3..* Nested Section Slice: Unordered, Open by value:code.text #xD; section:preparationIntervention S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.6.1 Preparation of Investigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218567 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.6.1-preparation #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:storageHandling S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.6.2 Storage and Handling of Investigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218568 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.6.2-storage-handling #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:accountability S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.6.3 Accountability of Investigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218569 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.6.3-accountability #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:assignmentAndBlinding S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218570 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.7-assignment-randomisation-blinding #xD; text 0..1 Narrative Text summary of the section, for human interpretation #xD; Slices for section 4..* Nested Section Slice: Unordered, Open by value:code.text #xD; section:assignment S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.7.1 Participant Assignment to Investigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218571 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.7.1-assignment #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:randomisation S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.7.2 Randomisation #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218572 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.7.2 Randomisation #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.7.2-randomisation #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:blinding S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.7.3 Measures to Maintain Blinding #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218573 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.7.3-blinding #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:unblinding S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.7.4 Emergency Unblinding at the Site #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218574 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.7.4-unblinding #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:adherence S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.8 Investigational Trial Intervention Adherence #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218575 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.8-intervention-adherence #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:noninvestigationalTherapy S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.9 Description of Noninvestigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218576 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.9-noninvestigational-interventions #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; Slices for section 0..* Nested Section Slice: Unordered, Open by value:code.text #xD; section:background S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.9.1 Background Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218577 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.9.1 Background Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.9.1-background-intervention #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:rescue S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.9.2 Rescue Therapy #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218578 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.9.2 Rescue Therapy #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.9.2-rescue-therapy #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:other S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.9.3 Other Noninvestigational Trial Intervention #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218579 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.9.3-other-therapy #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:concomitantTherapy S 1..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.10 Concomitant Therapy #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218580 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.10 Concomitant Therapy #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.10-concomitant-therapy #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; Slices for section 0..* Nested Section Slice: Unordered, Open by value:code.text #xD; section:prohibited S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.10.1 Prohibited Concomitant Therapy #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218581 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.10.1-prohibited-concomitant-therapy #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; section:permitted S 0..1 BackboneElement Nested Section #xD; title 0..1 string Label for section (e.g. for ToC) Required Pattern: 6.10.2 Permitted Concomitant Therapy #xD; code #xD; coding 1..1 Coding Code defined by a terminology system Required Pattern: At least the following #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: C218582 #xD; display 1..1 string Representation defined by the system Fixed Value: ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy #xD; text 1..1 string Plain text representation of the concept Required Pattern: section6.10.2-permitted-concomitant-therapy #xD; text 1..1 Narrative Text summary of the section, for human interpretation #xD; Documentation for this format
HL7 International / Clinical Decision Support
Profile of Composition for Evidence Based Medicine IG. The M11ReportSection06 Profile is used for section 6 (Trial Intervention) for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.
This Profile is developed to support the M11 Template. The ICH is the copyright holder for the M11 template and has not endorsed or sponsored this Profile.
A set of resources composed into a single coherent clinical statement with clinical attestation
A set of healthcare-related information that is assembled together into a single logical package that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. A Composition defines the structure and narrative content necessary for a document. However, a Composition alone does not constitute a document. Rather, the Composition must be the first entry in a Bundle where Bundle.type=document, and any other resources referenced from Composition must be included as subsequent entries in the Bundle (for example Patient, Practitioner, Encounter, etc.).
While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Entity, Role, or Act,Document[classCode="DOC" and moodCode="EVN" and isNormalAct()]
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional).
Indicates the mechanism used to compare versions to determine which is more current.
If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.
Must have either extensions or value[x], not both
A Boolean value to indicate that this artifact is authored for testing purposes (or education/evaluation/marketing) and is not intended to be used for genuine usage.
Natural language description of the artifact
A free text natural language description of the artifact from a consumer's perspective.
This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the artifact as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the artifact is presumed to be the predominant language in the place the artifact was created).
Explanation of why this artifact is needed and why it has been designed as it has.
This element does not describe the usage of the artifact. Instead, it provides traceability of ''why'' the resource is either needed or ''why'' it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this artifact.
A copyright statement relating to the artifact and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the artifact.
The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.
A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').
Defines the content expected to be rendered in all representations of the artifact. The (c) symbol should NOT be included in this string. It is expected to be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.
The date on which the asset content was approved by the publisher. Approval happens once when the content is officially approved for usage.
The date may be more recent than the approval date because of minor changes / editorial corrections.
The date on which the asset content was last reviewed. Review happens periodically after that, but doesn't change the original approval date.
If specified, this is usually after the approval date.
The effective date range for the resource
The period during which the resource content was or is planned to be effective.
The effective period for a resource determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 would be published in 2015.
The Resource contains content in a language additional to the one in the language element.
Contact details to assist a user in finding and communicating with the publisher.
May be a web site, an email address, a physical address, a telephone number, etc.
Specifies the publication date of the Resource.
The status of the processing for making the artifact publicly available, not necessarily the same as artifact status (Resource.status).
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Canonical identifier for this Composition, represented as a URI (globally unique)
An absolute URI that is used to identify this Composition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this Composition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the Composition is stored on different servers.
Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.
Allows the Composition to be referenced by a single globally unique identifier.
Version-independent identifier for the Composition
A version-independent identifier for the Composition. This identifier stays constant as the composition is changed over time.
Similar to ClinicalDocument/setId in CDA. See discussion in resource definition for how these relate.
An explicitly assigned identifier of a variation of the content in the Composition
While each resource, including the composition itself, has its own version identifier, this is a formal identifier for the logical version of the Composition as a whole. It would remain constant if the resources were moved to a new server, and all got new individual resource versions, for example.
registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document.
If a composition is marked as withdrawn, the compositions/documents in the series, or data from the composition or document series, should never be displayed to a user without being clearly marked as untrustworthy. The flag "entered-in-error" is why this element is labeled as a modifier of other elements. Some reporting work flows require that the original narrative of a final document never be altered; instead, only new narrative can be added. The composition resource has no explicit status for explicitly noting whether this business rule is in effect. This would be handled by an extension if required.
Need to be able to mark interim, amended, or withdrawn compositions or documents.
This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
The workflow/clinical status of the composition.
interim: .completionCode="IN" & ./statusCode[isNormalDatatype()]="active"; final: .completionCode="AU" && ./statusCode[isNormalDatatype()]="complete" and not(./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseComposition", code) and isNormalAct()]); amended: .completionCode="AU" && ./statusCode[isNormalDatatype()]="complete" and ./inboundRelationship[typeCode="SUBJ" and isNormalActRelationship()]/source[subsumesCode("ActClass#CACT") and moodCode="EVN" and domainMember("ReviseComposition", code) and isNormalAct() and statusCode="completed"]; withdrawn : .completionCode=NI && ./statusCode[isNormalDatatype()]="obsolete"
Specifies the particular kind of composition (e.g. History and Physical, Discharge Summary, Progress Note). This usually equates to the purpose of making the composition.
For Composition type, LOINC is ubiquitous and strongly endorsed by HL7. Most implementation guides will require a specific LOINC code, or use LOINC as an extensible binding.
Key metadata element describing the composition, used in searching/filtering.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
Clinical trial protocol Clinical trial protocol
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type.
Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.
High-level kind of a clinical document at a macro level.
.outboundRelationship[typeCode="COMP].target[classCode="LIST", moodCode="EVN"].code
ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
Who and/or what the composition is about
Who or what the composition is about. The composition can be about a person, (patient or healthcare practitioner), a device (e.g. a machine) or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).
Reference a Citation Resource, ArtifactAssessment Resource (Classification Profile), Group Resource (EvidenceReportSubject Profile), ReserchStudy Resource, or any Resource to define a subject of this EvidenceReport.
Essential metadata for searching for the composition. Identifies who and/or what the composition/document is about.
Describes the clinical encounter or type of care this documentation is associated with.
Provides context for the composition and supports searching.
unique(highest(./outboundRelationship[typeCode="SUBJ" and isNormalActRelationship()], priorityNumber)/target[moodCode="EVN" and classCode=("ENC", "PCPR") and isNormalAct])
The composition editing time, when the composition was last logically changed by the author.
The Last Modified Date on the composition may be after the date of the document was attested without being changed. This means that the date on an amended document is the date of the amendment, not the date of original authorship.
dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, [Bundle.timestamp](http://hl7.org/fhir/R5/bundle-definitions.html#Bundle.timestamp) is the date of packaging.
DocumentReference.content.attachment.date, DocumentReference.date
The context that the content is intended to support
The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate Composition instances.
When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.
Assist in searching for appropriate content.
Who and/or what authored the composition
Identifies who is responsible for the information in the composition, not necessarily who typed it in.
Identifies who is responsible for the content.
Name for this Composition (computer friendly)
A natural language name identifying the {{title}}. This name should be usable as an identifier for the module by machine processing applications such as code generation.
The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.
Support human navigation and code generation.
Official human-readable label for the composition.
For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a "consultation" or "progress note"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period.
DocumentReference.description, DocumentReference.content.attachment.title
A comment, general note or annotation not coded elsewhere.
A participant who has attested to the accuracy of the composition/document.
Identifies responsibility for the accuracy of the composition content.
All FHIR elements must have a @value or children or both
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
reviewer | editor | endorser | informant | recorder
The type of attestation the authenticator offers.
Indicates the level of authority of the attestation.
implied by .authenticator/.legalAuthenticator
When the composition was attested by the party.
Identifies when the information in the composition was deemed accurate. (Things may have changed since then.).
./time[type="TS" and isNormalDatatype()]
Who attested the composition in the specified way.
Identifies who has taken on the responsibility for accuracy of the composition content.
./role[classCode="ASSIGNED" and isNormalRole]/player[determinerCode="INST" and classCode=("DEV", "PSN") and isNormalEntity()] or ./role[classCode="ASSIGNED" and isNormalRole and not(player)]/scoper[determinerCode="INST" and classCode="ORG" and isNormalEntity()]
Organization which maintains the composition
Identifies the organization or group who is responsible for ongoing maintenance of and access to the composition/document information.
This is useful when documents are derived from a composition - provides guidance for how to get the latest version of the document. This is optional because this is sometimes not known by the authoring system, and can be inferred by context. However, it is important that this information be known when working with a derived document, so providing a custodian is encouraged.
Identifies where to go to find the current version, where to report issues, etc.
.participation[typeCode="RCV"].role[classCode="CUST"].scoper[classCode="ORG" and determinerCode="INST"]
Relationships to other compositions/documents
Relationships that this composition has with other compositions or documents (FHIR or non-FHIR resources) that already exist.
To reference (using relatesTo) a Bundle of type "document" or another Composition where you only have the identifier, use a targetReference with an identifier.\ When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource. Here is an example of using relatesTo to reference another Bundle of type "document" or Composition where you only have the identifier: ``` "relatesTo": [{ "type": "replaces", "targetReference": { "identifier": { "system": "...", "value": "..." } } }] ```
Additional classifiers for RelatedArtifacts
Provides additional classifiers of the related artifact.
documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
The type of relationship to the related artifact.
The artifact that is related to this Composition
The artifact that is related to this Composition Resource.
The clinical service(s) being documented
The clinical service, such as a colonoscopy or an appendectomy, being documented.
The event needs to be consistent with the type element, though can provide further information if desired.
Provides context for the composition and creates a linkage between a resource describing an event and the composition created describing the event.
The period of time covered by the documentation. There is no assertion that the documentation is a complete representation for this period, only that it documents events during this time.
The event(s) being documented, as code(s), reference(s), or both
Represents the main clinical acts, such as a colonoscopy or an appendectomy, being documented. In some cases, the event is inherent in the typeCode, such as a "History and Physical Report" in which case the procedure being documented is necessarily a "History and Physical" act. The events may be included as a code or as a reference to an other resource.
An event can further specialize the act inherent in the typeCode, such as where it is simply "Procedure Report" and the procedure was a "colonoscopy". If one or more events are included, they SHALL NOT conflict with the values inherent in the classCode, practiceSettingCode or typeCode, as such a conflict would create an ambiguous situation. This short list of codes is provided to be used as key words for certain types of queries.
This list of codes represents the main clinical acts being documented.
The root of the sections that make up the composition.
A section must contain at least one of text, entries, or sub-sections
text.exists() or entry.exists() or section.exists()
A section can only have an emptyReason if no entries are included
./outboundRelationship[typeCode="COMP" and isNormalActRelationship()]/target[moodCode="EVN" and classCode="DOCSECT" and isNormalAct]
The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.
The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.
Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.
A code identifying the kind of content contained within the section. This must be consistent with the section title.
The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document. If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.
Provides computable standardized labels to topics within the document.
Who and/or what authored the section, when the section is authored by someone other than the composition.author
Identifies who is responsible for the information in this section, not necessarily who typed it in. The actual author of the section when it is not the author of the composition. If author is not specified, the author is assumed to be the author of the parent section or the author of the composition.
Who/what the section is about, when it is not about the subject of composition
The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).
Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.
.subject? (CDA did not differentiate between subject and focus)
Text summary of the section, for human interpretation
A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.
Document profiles may define what content should be represented in the narrative to ensure clinical safety.
Specifies the order applied to the items in the section entries.
Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.
Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.
What order applies to the items in the entry.
.outboundRelationship[typeCode=COMP].sequenceNumber > 1
A reference to data that supports this section
A reference to the actual resource from which the narrative in the section is derived.
If there are no entries in the list, an emptyReason SHOULD be provided.
.outboundRelationship[typeCode=COMP] or .participation[typeCode=SBJ]
If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.
The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.
Allows capturing things like "none exist" or "not asked" which can be important for most lists.
A nested sub-section within this section.
Nested sections are primarily used to help human readers navigate to particular portions of the document.
6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
Trial interventions are all pre-specified investigational and noninvestigational medicinal products, medical devices or other interventions intended for the participants during the trial. The investigational trial intervention is the product used in the trial as part of trial objectives. Description of the investigational trial intervention is provided in Section 6.1 Description of Trial Intervention. Other trial interventions that are not part of trial objectives or do not have an investigational role in this trial are described in Section 6.9 Description of Noninvestigational Trial Interventions. Any regional requirements should be noted in the appropriate subsections. Provide an overview of investigational and noninvestigational trial interventions. Classify the trial intervention as IMP, NIMP/AxMP designations based on trial design and regional requirements. Consider an optional table with 12 columns (Arm Name, Arm Type, Intervention Name, Intervention Type, Pharmaceutical Dose Form, Dosage Strength(s), Dosage Level(s), Route of Administration, Regimen/Treatment Period/Vaccination Regimen, Use, IMP/NIMP, Sourcing).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).
6.1 Description of Investigational Trial Intervention
Classification of a section of a composition/document.
ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention
Describe the investigational trial intervention to be administered in each arm of the trial and for each period of the trial including route and mode of administration, dose, dosage regimen, duration of intervention, use, packaging and labelling. Refer to approved regional labelling, as appropriate. For investigational drug/device combination products, include details on the configuration and use of the device and device manufacturer. A device user manual may be referenced in this section. Entries should Reference ConceptualExposureDefinition Profile of Group Resource.
6.2 Rationale for Investigational Trial Intervention Dose and Regimen
ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen
Provide a rationale for the selection of the dose(s) or dose range, pharmaceutical dose form, route of administration, and dosing regimen of the investigational trial intervention, as applicable. This rationale should include relevant results from nonclinical studies and clinical trials that support selection of the dose and regimen. Discuss impact of differences in trial population characteristics (e.g., age, sex, race) which could lead to differences in pharmacokinetics and pharmacodynamics in this trial as compared to previous trials. If applicable, justify any differences in dose regimen or therapeutic use relative to approved labelling. Describe prior trials and other information that support the dose and/or dose regimen of the investigational trial intervention. Include a rationale for prospective dose adjustments incorporated in the trial, if any. Entries should Reference ConceptualExposureDefinition Profile of Group Resource.
6.3 Investigational Trial Intervention Administration
ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration
Describe the detailed procedures for administration of each participant’s dose of each investigational trial intervention. This may include the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time participants will be administered the investigational trial intervention), and the timing of dosing relative to meals. Include any specific instructions on who, when or how to prepare and take the dose(s) and how to handle any delayed or missed doses. Dose escalation or cohort expansion as part of the overall design should be covered in Section 4.1 Description of Trial Design. Entries should Reference ActivityDefinition Resource.
6.4 Investigational Trial Intervention Dose Modification
ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification
For each participant, describe any dose modifications allowed, including conditions for such dose modifications, particularly regarding failure to respond or safety concerns. State any minimum period required before a participant’s dose might be raised to the next higher dose or dose range. Include whether it is permissible to start and stop treatment and how dose reductions (if permitted) are to be managed. Information on stopping investigational trial intervention for participants due to safety/other reasons should be described in Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial. Entries should Reference ActivityDefinition Resource.
6.5 Management of Investigational Trial Intervention Overdose
ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose
Describe what is meant by investigational trial intervention overdose. Provide any available information on managing the overdose and ensure it is consistent with the Investigator’s Brochure or product labelling. Cross reference these documents as applicable. Entries should Reference ActivityDefinition Resource or PlanDefinition Resource.
6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
No text is intended here (heading only).
6.6.1 Preparation of Investigational Trial Intervention
ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention
Describe any preparation of the investigational trial intervention, and when necessary, who should prepare it. When applicable, describe the maximum hold time once thawed/mixed before administration. Include thawing, diluting, mixing, and reconstitution/preparation instructions. For drug/device combination products, include any relevant assembly or use instructions and reference the package insert that is provided separately. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in separate documents provided to the site (e.g., a pharmacy manual and reference the separate documents.
6.6.2 Storage and Handling of Investigational Trial Intervention
ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention
Describe storage and handling requirements (e.g., protection from light, temperature, humidity) for the investigational trial intervention(s). For trials in which multi-dose vials are utilised, provide additional information regarding stability and expiration time after initial use (e.g., if the seal is broken). Explain how the investigational trial intervention will be provided to the Investigator. If applicable, include details about kits, packaging, or other material of the investigational trial intervention for blinding purposes. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in separate documents provided to the site (e.g., a pharmacy manual) and reference the separate documents.
6.6.3 Accountability of Investigational Trial Intervention
ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention
Describe the accountability method, including: • how the investigational trial intervention will be distributed • who will distribute the investigational trial intervention • participation of a drug storage repository or pharmacy, if applicable • plans for disposal or return of unused product • if applicable, plans for reconciliation of investigational trial intervention
6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
6.7.1 Participant Assignment to Investigational Trial Intervention
ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention
State that at enrollment, participant identification codes should be assigned. Describe the method of assigning participants to investigational trial intervention without being so specific that blinding or randomisation might be compromised. If assignment to investigational trial intervention is by randomisation, describe when randomisation occurs relative to screening. If adaptive randomisation or other methods of covariate balancing/minimisation are employed, include a cross reference to the methods of analysis in Section 10 Statistical Considerations. As applicable, details regarding the implementation of procedures to minimise bias should be described.
ICH M11 Protocol Section 6.7.2 Randomisation
Describe the randomisation procedures (e.g., central randomisation procedures), the method used to generate the randomisation schedule (e.g., computer generated), the source of the randomisation schedule (e.g., sponsor, investigator, or other), and whether IxRS will be used. To maintain the integrity of the blinding, do not include the block size.
ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding
Describe measures that will be used to maintain blinding: • The investigational trial interventions are as indistinguishable as possible • Plans for the maintenance of randomisation codes and appropriate blinding for the trial • Procedures for planned (e.g., interim analysis) and unintentional (e.g., breach of procedure) breaking of randomisation codes. For unplanned but intentional actions (e.g., safety events), refer to Section 6.7.4 Emergency Unblinding at the Site. If the trial allows for some investigators or other designated staff to remain unblinded (e.g., to allow them to adjust investigational trial intervention), the means of maintaining the blinding for other investigators or staff should be explained. Measures to prevent unblinding by laboratory measurements or while performing study assessments, if used, should be described.
ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site
Describe the criteria for breaking the trial blind or participant code. Describe the circumstances in which the blinding would be broken for an individual or for all participants and who has responsibility. Include the procedure for emergency unblinding such as via IxRS or code envelopes as well as documentation of unblinding. Indicate to whom the intentional and unintentional unblinding should be reported.
6.8 Investigational Trial Intervention Adherence
ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence
Describe the measures to monitor and document participants’ adherence with investigational trial intervention (e.g., trial intervention accountability records, diary cards, or investigational trial intervention concentration measurements). List what documents are mandatory to complete (e.g., participant drug log) and what source data/records will be used to document investigational trial intervention adherence.
6.9 Description of Noninvestigational Trial Intervention
ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention
As stated in Section 6 Trial Intervention and Concomitant Therapy, noninvestigational interventions are pre-specified products used in the trial but are not part of trial objectives and hence, are not investigational trial interventions.
ICH M11 Protocol Section 6.9.1 Background Trial Intervention
Describe any background intervention(s), including administration and any conditions for use.
ICH M11 Protocol Section 6.9.2 Rescue Therapy
List all permitted rescue medications, treatments, and/or procedures, including any relevant instructions on administration and any conditions of use. If administration of rescue therapy leads to the temporary discontinuation of trial intervention or a participant’s withdrawal from the trial, refer to Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial.
6.9.3 Other Noninvestigational Trial Intervention
ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention
If applicable, describe the use of any other noninvestigational trial intervention, e.g., challenge agents or diagnostics.
ICH M11 Protocol Section 6.10 Concomitant Therapy
Specify the concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures which are prohibited or permitted during the trial and include details about when the information will be collected (e.g., during screening, at each visit). When appropriate to separate the content, subheadings may be used.
ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy
If applicable, describe any prohibited concomitant therapy.
ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy
If applicable, describe any permitted concomitant therapy.