FHIR to CDISC (CDASH, SDTMIG 3.2)

1a. Project Name FHIR to CDISC 1b. Project ID 1636 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed N/A 1g. Project Artifact Information 1h. ISO/IEC Standard to Adopt 1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption? 1j. Unit of Measure 2a. Primary/Sponsor WG Biomedical Research & Regulation 2c. Co-Sponsor Level of Involvement Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2c. Co-Sponsor Update Periods N/A 2d. Project Facilitator Mike Hamidi, Rebecca Baker 2e. Other Interested Parties (and roles) N/A 2f. Modeling Facilitator Mike Hamidi 2g. Publishing Facilitator Lloyd McKenzie 2h. Vocabulary Facilitator N/A 2i. Domain Expert Representative N/A 2j. Business Requirements Analyst N/A 2k. Conformance Facilitator Lloyd McKenzie 2l. Other Facilitators N/A 2m. Implementers TBD 3a. Project Scope The overarching goal of this project is to improve interoperability, and facilitate the exchange of data from EHRs to clinical research submission-ready datasets. Building upon previous work on the FDA eSource grant, the PHUSE Research on FHIR projects, and the CDMH project, CDISC will collaborate with HL7, TransCelerate BioPharma and other potential partners to complete the development of a fully SME reviewed/approved FHIR-to-CDISC (CDASH and SDTMIG 3.2) mappings for seven core domains (AE, CM, DM, MH, PR and VS). The mappings will be jointly balloted by CDISC and HL7 using their respective governance processes. Based on potential gaps identified through the mapping activities, CDISC standards may be enhanced/expanded. This will aid in either potentially eliminating and/or reducing such gaps that account for RWD digital sources (e.g., EHRs, ePROs, TeleHealth, etc.) and to improve interoperability. The official authoritative FHIR-to-CDISC mappings will be published as: 1) FHIR IG and 2) CDISC Library (CDISC's MDR) as either HTML, JSON or XML media types. Both publication formats will be made freely accessible for use. Making the mappings available via the CDISC Library API permits software vendors to integrate within their systems and to use them to automate eSource and other such related activities. In addition, the mappings will include FHIR R5 draft mapping solutions and mitigation instructions to aid in future maintenance updates. The project will collaborate with CDISC, Vulcan, PHUSE, TransCelerate BioPharma, and other potential organizations to review the mappings for consistency and quality purposes as well as to create examples to aid implementer's. Attachments 3b. Project Need The FDA mandates that clinical trial data used to support approval of drugs and devices is submitted using CDISC standards. However, much of the research is conducted using clinical systems where data is typically exposed and shared as FHIR. Having standardized mappings for converting that clinical data for research use will save significant time on redundant data entry, independent mapping exercises and conversion issues. 3c. Security Risk No 3d. External Drivers N/A 3e. Objectives/Deliverables and Target Dates 1) Project scoping and planning: January 2020 through June 2020 --Mappings from FHIR-to-CDISC for LB, AE, VS, CM, MH, DM and PR domains 2) FHIR R4 to CDASHIG v2.1/SDTMIG v3.2 Mappings: March 2020 through September 2020 --Activities include initial mappings w/FHIR R5 gap analysis, SME review of mappings by CDISC and BR&R, and FHIR IG loading/preparations 3) Formal Review & Balloting: September 2020 through February 2021 --Activities include both CDISC internal/public review and HL7 balloting process 4) Publication: March 2021 through Aril 2021 --Deliverables include a finalized FHIR IG and machine readable metadata via CDISC Library (i.e., CIDSC’s MDR) 3f. Common Names / Keywords / Aliases: N/A 3g. Lineage N/A 3h. Project Dependencies N/A 3i. HL7-Managed Project Document Repository URL: https://github.com/HL7/fhir-cdisc-map 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? N/A 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies CDISC Controlled Terminology 3o. Earliest prior release and/or version to which the compatibility applies N/A 4a. Products FHIR Extensions, FHIR Implementation Guide, FHIR Profiles 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? R4 4c. FHIR Profiles Version FHIR vR4 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Implementation Guide (IG) will be created/modified 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? No 5a. Externally developed IG is to be (select one) 5a. Specify external organization N/A 5a. Revising Current Standard Info FHIR vR4, CDASH v2.1 5b. Project Ballot Type Informative 5c. Additional Ballot Info N/A 5d. Joint Copyright Yes 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. Yes 6a. External Project Collaboration CDISC, PHUSE, TransCelerate BioPharma, IHE? 6b. Content Already Developed 10% 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? Yes 6f. Stakeholders Regulatory Agency, Standards Development Organizations (SDOs) 6f. Other Stakeholders 6g. Vendors Pharmaceutical, EHR, PHR, HIS 6g. Other Vendors 6h. Providers 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Jun 16, 2020 7c. Co-Sponsor Approval Date 7c. Co-Sponsor 2 Approval Date 7c. Co-Sponsor 3 Approval Date 7c. Co-Sponsor 4 Approval Date 7c. Co-Sponsor 5 Approval Date 7c. Co-Sponsor 6 Approval Date 7c. Co-Sponsor 7 Approval Date 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date 7f. FMG Approval Date Aug 19, 2020 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Aug 16, 2020 7j. TSC Approval Date