1. Make the title of this page the name of your IG Proposal (the appropriate label is already attached to the page).
2. Fill out fields below
3. Publish page at bottom right
4. Get the IG sponsor work group to approve the content and update the Committee Approval Date
5. Send an email to firstname.lastname@example.org to trigger a review of the content on one of the FHIR Management Group's regular calls.
Committee Approval Date:
This is the date the sponsor for the IG approved the text of this IG proposal (objective is to ensure they agree with the realm, code descriptions, etc).
If there are problems with an IG or questions about readiness, this is who HL7 staff and/or the FMG will follow up with.
Contributing or Reviewing Work Groups:
Who needs to review the IG prior to ballot or final publication
FHIR Development Project Insight ID:
'Pending' is ok, so long as the PSS has been submitted to HQ
Scope of coverage:
What are the scope boundaries of this resources? Specifically, how is it distinct from other IGs in the core space? Who is it targeted at? Note that what we want is the overall scope of what it will eventually be, not necessarily what's covered by the current project. The objective is to ensure that we "right-size" IG scopes so that the publications we have 5+ years from now will have clear boundaries and will fit well together. (Please don't just copy the scope section from your PSS.)
The implementation guide provides mappings between the current official release of the core FHIR specification and the current official releases of the CDISC SDTM and CDASH specifications
What is the URL for the Github repository where the IG source is maintained? Note that this must generally be under https://github.com/HL7/
Proposed IG realm and code:
Realm should generally be 'us' or 'uv'. The 'code' is what will appear as the URL of the IG. It needs to be relatively short, unique within the HL7 space and as intuitive as possible for implementers looking at it. It must also be all lower-case.
FHIR Core version(s):
What version(s) of FHIR will the IG be associated with in its initial release?
Who will be maintaining this content in the long term (5-10 years down the road - after the initial development project is finished).
CDISC expects to work with the BR&R work group to continue to maintain and potentially expand the mappings as FHIR and the CDISC specifications continue to evolve
DO NOT COPY FROM PSS. This is a short (2-3 sentence) description of the IG content expressed in present tense that describes what the IG does and who it's for. It will be displayed in the initial search results for the IG and will allow future implementers to evaluate whether the implementation guide has potential relevance when scanning through a list of possible IGs that met their search criteria. This should not talk about the project or work group at all.
This implementation guide defines authoritative mappings between the CDISC LAB, SDTM and CDASH standards and the corresponding HL7 FHIR resources to ease interoperability and data conversion between systems implementing these standards.
DO NOT COPY FROM PSS. This is a longer (2-3 paragraph) description of the IG content expressed in present tense that describes what the IG does and who it's for. It will be displayed as the detailed registry entry for a given implementation guide in the IG registry. It should provide information about the scope of the IG, what systems it covers and what type of interoperability it enables. This should also not talk about the project or work group. It should be written from the perspective of the project being long complete and someone is just evaluating the artifacts.
CDISC's LAB, SDTM and CDASH specifications are widely used in the clinical research community, while HL7 FHIR is becoming increasingly dominant in clinical systems. This implementation guides defines 'best practice' mappings based on the expertise of both organizations. Because of variations in implementation and study design, the mappings will need to be adapted to specific implementations. However, having a jointly published (and publicly reviewed) set of mappings between the two organization's specifications will increase interoperability and reduce costs for converting between the standards.
What external agencies (if any) are involved in the creation of the IG?
CDISC, TransCelerate Biopharma
What implementers have already committed to the IG or are otherwise expected. The focus of HL7 is getting widespread implementation of specifications, not just balloting them, so the FMG wants to know what implementer reach-out has occurred and what degree of implementer commitment exists. Also, specifications must generally meet FMM 2 maturity criteria (at least 3 independent test implementations successfully demonstrating interoperability across most of the IG scope) prior to going to ballot
These mappings aren't expected to be implemented directly, but rather to guide mapping and conversion efforts by different organizations.
Where are/will the requirements for the IG being taken from? What external specifications are being consulted?
CDISC and HL7 specifications
Provide a short description of 2-3 interoperability exchanges that will be enabled by this IG
- Real-world evidence studies will be able to extract data from clinical systems for use in regulatory submissions
- Clinical research management systems can support data capture directly in clinical systems while still making it available for regulatory submission
- Researchers designing retrospective studies can identify where particular data elements are typically exposed in clinical systems
Does your IG depend on any other IGs? If so which ones? Are you expecting other IGs to depend on your IG? If so, which ones?
Overlaps in part with the Clinical Research Sponsor Laboratory Semantics in FHIR implementation guide. The Clinical Research Sponsor Laboratory Semantics in FHIR IG covers content not covered by this mapping IG - it defines profiles and implementation requirements. On the other hand, this IG covers most CDISC domains, including vital signs, medications, adverse events, while Laboratory Semantics in FHIR only covers the lab domain (CDISC LAB and LB standards). BR&R expects to resolve the overlap such that authoritative mappings are maintained in only one IG, while domain-specific implementation guidance will exist in other IGs.
When do you expect to bring the proposed IG to ballot for the first time?
January 2021 cycle
Leave this area blank. The FMG will fill in any changes they would like to see or questions they have during their review here.