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Difference between revisions of "StudyParticipation FHIR Resource Proposal"

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Current version: https://confluence.hl7.org/display/FHIR/StudyParticipation+FHIR+Resource+Proposal<div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>
 
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This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
 
This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
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=PutProposedResourceNameHere=
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=StudyParticipation=
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<!-- Resource names should meet the following characteristics:
 
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==Owning committee name==
 
==Owning committee name==
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[[Regulated_Clinical_Research_Information_Management]]
  
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<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
 
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[[YourCommitteeName]]
 
 
==Committee Approval Date:==
 
==Committee Approval Date:==
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<i>Please enter the date that the committee approved this Resource proposal</i>
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Pending
  
 
==Contributing or Reviewing Work Groups==
 
==Contributing or Reviewing Work Groups==
  
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<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
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*[[BRIDG]]
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* Work Group Name
 
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* or link
 
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* or "None"
 
  
 
==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
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Pending?
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<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 
  
 
==Scope of coverage==
 
==Scope of coverage==
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This resource manages the linkage between a study subject (Patient) and a particular study.  It covers both human and animal subjects and captures information about their participation in the study - what arm they were assigned to, what arm they actually completed, when they started and stopped participation, etc.
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<!-- Define the full scope of coverage for the resource.  The scope must be clearly delineated such that it does not overlap with any other existing or expected resource.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
 
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Scope should consider numerous aspects of breadth of scope, including:
 
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* Subject: Human vs. non-human vs. non-patient (e.g. lab bench medicine)
 
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* Disciplines: Environmental Health, Palliative, Respiratory, Psychology, Maternity, Clinical Research
 
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* Delivery environment (Community, Geriatric, Home care, Emergency, Inpatient, Intensive, Neonatal, Pediatric, Primary)
 
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==RIM scope==
 
==RIM scope==
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Observation[classCode=CLNTRL, moodCode=EVN]
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<!-- Identify the formal RIM mapping for the root concept of the resource.  The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
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(A StudyParticipation is essentially a mini clinical trial with a subject of 1 from a RIM perspective)
  
 
==Resource appropriateness==
 
==Resource appropriateness==
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A key aspect of tracking research studies is tracking the involvement of the individual study subjects.  This information is relevant to care delivery (is my patient a member of any clinical trials), trial management and trial result reporting.  Each participation has its own status.  Access permissions may vary for different sets of participants for different users.  Each participation can have its own id, though these are typically captured on the study subject themselves (i.e. the patient).  This resource is needed to support DAF research, for mapping BRIDG to FHIR and for mapping CDISC specifications to FHIR.  The number of data elements should be closer to the 20 side than the 50 side.
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<!-- Does the resource meet the following characteristics?
 
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* Declared interest in need for standardization of data exchange</span>
 
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* Have the characteristics of high cohesion & low coupling – need to explore whether coupling is good some places, not elsewhere – layers from Bo’s document
 
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==Expected implementations==
 
==Expected implementations==
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DAF research, BRIDG and CDISC mappings, and potential future use in clinical research submission specificaitons.
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<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
 
  
 
==Content sources==
 
==Content sources==
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BRIDG, SDTM/SEND, pCOREnet
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<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
 
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==Example Scenarios==
 
==Example Scenarios==
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Track study enrollment, current patient status, what arm the patient was assigned to, what stage of the trail the patient is in, when they left the trial, reason for leaving the trial, etc.
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<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this resource.  They should demonstrate the full scope of the resource and allow exercising of the resources capabilities (full element coverage, inclusion & omission of optional elements, repeating and singleton repeating elements, etc.) -->
 
  
 
==Resource Relationships==
 
==Resource Relationships==
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Will always be linked to a Study and a Patient.  May be linked to other relevant data (though more likely to have data linked directly to study?
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<!-- What are the resources do you expect will reference this resource and in what context?
 
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What resources do you expect this resource reference and in what context?
 
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Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
 
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==Timelines==
 
==Timelines==
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Intention is to have a draft included in the STU 3 publication (for DAF Research) as a placeholder. STU in release 4
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<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
 
  
 
==gForge Users==
 
==gForge Users==
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Rik Smithies, Lloyd McKenzie (already have committer access)
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<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->
 
  
 
==When Resource Proposal Is Complete==
 
==When Resource Proposal Is Complete==
 
'''When you have completed your proposal, please send an email to [mailto:FMGcontact@HL7.org FMGcontact@HL7.org]'''
 
'''When you have completed your proposal, please send an email to [mailto:FMGcontact@HL7.org FMGcontact@HL7.org]'''

Latest revision as of 15:29, 31 October 2019

Current version: https://confluence.hl7.org/display/FHIR/StudyParticipation+FHIR+Resource+Proposal
OpenHotTopic.GIF

This page documents a Pending FHIR Resource Proposal



StudyParticipation

Owning committee name

Regulated_Clinical_Research_Information_Management

Committee Approval Date:

Pending

Contributing or Reviewing Work Groups

FHIR Resource Development Project Insight ID

Pending?

Scope of coverage

This resource manages the linkage between a study subject (Patient) and a particular study. It covers both human and animal subjects and captures information about their participation in the study - what arm they were assigned to, what arm they actually completed, when they started and stopped participation, etc.

RIM scope

Observation[classCode=CLNTRL, moodCode=EVN] (A StudyParticipation is essentially a mini clinical trial with a subject of 1 from a RIM perspective)

Resource appropriateness

A key aspect of tracking research studies is tracking the involvement of the individual study subjects. This information is relevant to care delivery (is my patient a member of any clinical trials), trial management and trial result reporting. Each participation has its own status. Access permissions may vary for different sets of participants for different users. Each participation can have its own id, though these are typically captured on the study subject themselves (i.e. the patient). This resource is needed to support DAF research, for mapping BRIDG to FHIR and for mapping CDISC specifications to FHIR. The number of data elements should be closer to the 20 side than the 50 side.

Expected implementations

DAF research, BRIDG and CDISC mappings, and potential future use in clinical research submission specificaitons.

Content sources

BRIDG, SDTM/SEND, pCOREnet

Example Scenarios

Track study enrollment, current patient status, what arm the patient was assigned to, what stage of the trail the patient is in, when they left the trial, reason for leaving the trial, etc.

Resource Relationships

Will always be linked to a Study and a Patient. May be linked to other relevant data (though more likely to have data linked directly to study?

Timelines

Intention is to have a draft included in the STU 3 publication (for DAF Research) as a placeholder. STU in release 4

gForge Users

Rik Smithies, Lloyd McKenzie (already have committer access)

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

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