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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:

TBD

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

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

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

7j. TSC Approval Date



 Show Changes

Version

12

Modifier

Rhonda Facile

Modify Date

Jul 09, 2020 21:26

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 now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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.

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:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

11

Modifier

Mike Hamidi

Modify Date

Jul 01, 2020 17:47

1a. Project Name

FHIR to CDASH

1b. Project ID

1636

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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

Rhonda Facile, 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-CDASH 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-CDASH 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.

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:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

10

Modifier

Rhonda Facile

Modify Date

Jun 29, 2020 15:14

1a. Project Name

FHIR to CDASH

1b. Project ID

1636

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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

Rhonda Facile, 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-CDASH 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-CDASH 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.

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

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3f. Common Names / Keywords / Aliases:

N/A

3g. Lineage

N/A

3h. Project Dependencies

N/A

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

9

Modifier

Dave Hamill

Modify Date

Jun 24, 2020 21:57

1a. Project Name

FHIR to CDASH

1b. Project ID

1636

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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

Rhonda Facile, Mike Hamidi

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-CDASH 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-CDASH 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.

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

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3f. Common Names / Keywords / Aliases:

N/A

3g. Lineage

N/A

3h. Project Dependencies

N/A

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

8

Modifier

Mike Hamidi

Modify Date

Jun 17, 2020 15:51

1a. Project Name

FHIR to CDASH

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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

Rhonda Facile, Mike Hamidi

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-CDASH 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-CDASH 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.

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

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3f. Common Names / Keywords / Aliases:

N/A

3g. Lineage

N/A

3h. Project Dependencies

N/A

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

7

Modifier

Mike Hamidi

Modify Date

Jun 17, 2020 15:50

1a. Project Name

FHIR to CDASH

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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

Rhonda Facile, Mike Hamidi

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-CDASH 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 FHIR-to-CDASH 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.

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

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3f. Common Names / Keywords / Aliases:

N/A

3g. Lineage

N/A

3h. Project Dependencies

N/A

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

6

Modifier

Mike Hamidi

Modify Date

Jun 17, 2020 15:46

1a. Project Name

FHIR to CDASH

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

N/A

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

Rhonda Facile, Mike Hamidi

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-CDASH 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 FHIR-to-CDASH 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.

The mappings will be developed using CDASHIG v2.1 and FHIR vR4 to include the relevant US Core Implementation Guide (IG) extensions. The US Core IG covers the ONC 2015 Edition Common Clinical Data Set (CCDS) and the proposed ONC U.S. Core Data for Interoperability (USCDI). 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.

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

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3f. Common Names / Keywords / Aliases:

N/A

3g. Lineage

N/A

3h. Project Dependencies

N/A

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

5

Modifier

Mike Hamidi

Modify Date

Jun 17, 2020 15:44

1a. Project Name

FHIR to CDASH

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

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

at WGMs

2d. Project Facilitator

Rhonda Facile, Mike Hamidi

2f. Modeling Facilitator

Mike Hamidi

2g. Publishing Facilitator

Lloyd McKenzie

2k. Conformance Facilitator

Lloyd McKenzie

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-CDASH 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 FHIR-to-CDASH 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.

The mappings will be developed using CDASHIG v2.1 and FHIR vR4 to include the relevant US Core Implementation Guide (IG) extensions. The US Core IG covers the ONC 2015 Edition Common Clinical Data Set (CCDS) and the proposed ONC U.S. Core Data for Interoperability (USCDI). 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.

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

3e. Objectives/Deliverables and Target Dates

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

Yes

3n. List of Vocabularies

CDISC Controlled Terminology

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Revising Current Standard Info

FHIR vR4, CDASH v2.1

5b. Project Ballot Type

Informative

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

4

Modifier

Mike Hamidi

Modify Date

Jun 17, 2020 15:34

1a. Project Name

FHIR to CDASH

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

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

at WGMs

2d. Project Facilitator

Rhonda Facile, Mike Hamidi

2f. Modeling Facilitator

Mike Hamidi

2g. Publishing Facilitator

Lloyd McKenzie

2k. Conformance Facilitator

Lloyd McKenzie

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-CDASH 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 FHIR-to-CDASH mappings will be published as: 1) FHIR IG and 2) CDISC Library (CDISC's MDR). 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.

The mappings will be developed using CDASHIG v2.1 and FHIR vR4 to include the relevant US Core Implementation Guide (IG) extensions. The US Core IG covers the ONC 2015 Edition Common Clinical Data Set (CCDS) and the proposed ONC U.S. Core Data for Interoperability (USCDI).

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.

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

3e. Objectives/Deliverables and Target Dates

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

Yes

3n. List of Vocabularies

CDISC Controlled Terminology

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Revising Current Standard Info

FHIR vR4, CDASH v2.1

5b. Project Ballot Type

Informative

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

3

Modifier

Mike Hamidi

Modify Date

Jun 17, 2020 15:28

1a. Project Name

FHIR to CDASH/SDTM

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

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

at WGMs

2d. Project Facilitator

Rhonda Facile, Mike Hamidi

2f. Modeling Facilitator

Mike Hamidi

2g. Publishing Facilitator

Lloyd McKenzie

2k. Conformance Facilitator

Lloyd McKenzie

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-CDASH 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 FHIR-to-CDASH mappings will be published as: 1) FHIR IG and 2) CDISC Library (CDISC's MDR). 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.

The mappings will be developed using CDASHIG v2.1 and FHIR vR4 to include the relevant US Core Implementation Guide (IG) extensions. The US Core IG covers the ONC 2015 Edition Common Clinical Data Set (CCDS) and the proposed ONC U.S. Core Data for Interoperability (USCDI).

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.

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

3e. Objectives/Deliverables and Target Dates

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

Yes

3n. List of Vocabularies

CDISC Controlled Terminology

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Revising Current Standard Info

FHIR vR4, CDASH v2.1

5b. Project Ballot Type

Informative

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

2

Modifier

Lloyd McKenzie

Modify Date

Jun 10, 2020 22:35

1a. Project Name

FHIR to CDASH/SDTM

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

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

at WGMs

2d. Project Facilitator

Rhonda Facile, Mike Hamidi

2f. Modeling Facilitator

Mike Hamidi

2g. Publishing Facilitator

Lloyd McKenzie

2k. Conformance Facilitator

Lloyd McKenzie

3a. Project Scope

The overarching goal of this project is to improve interoperability, and facility the flow of data from EHRs to clinical research submission data sets. Building on learnings from 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 partners to complete the development of fully vetted FHIR to CDASH mappings for seven core domains (AE, CM, DM, MH, Procedures and VS). The mappings will be jointly balloted by CDISC and HL7 using their respective governance processes. Based on gaps identified, CDISC standards may be enhanced/expanded to account for RWD digital sources (e.g., EHRs, ePROs, TeleHealth, etc.) and to improve interoperability.

The mappings will be published as both a FHIR implementation guide and as part of the CDISC Library. Both representations will provide free access for all. Making the mappings available via the CDISC Library API permits software tools to use them to automate eSource and other integration tasks.

The mappings will be developed using CDASH v2.1 and FHIR vR4 to include the relevant US Core Implementation Guide (IG) extensions. The US Core IG covers the ONC 2015 Edition Common Clinical Data Set (CCDS) and the proposed ONC U.S. Core Data for Interoperability (USCDI).

The project will collaborate with CDISC, Vulcan, PHUSE, TransCelerate BioPharma, and other groups to review the mappings for consistency and quality purposes as well as to create examples to aid implementers.

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

3e. Objectives/Deliverables and Target Dates

Formal mappings expressed as a FHIR IG balloted as informative: January 2020 ballot cycle

3i. HL7-Managed Project Document Repository URL:

TBD

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

Yes

3n. List of Vocabularies

CDISC Controlled Terminology

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

5a. Project Intent

Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Revising Current Standard Info

FHIR vR4, CDASH v2.1

5b. Project Ballot Type

Informative

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%

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR, HIS

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR

Version

1

Modifier

Rhonda Facile

Modify Date

Jun 10, 2020 21:45

1a. Project Name

FHIR to CDASH/SDTM

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

FHIR

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

at WGMs

2d. Project Facilitator

Rhonda Facile, Mike Hamidi

2f. Modeling Facilitator

Mike Hamidi

2k. Conformance Facilitator

Lloyd MacKenzie

3a. Project Scope

The overarching goal of this project is to improve interoperability, and facility the flow of data from EHRs to submission data sets. Building on learnings from 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 partners to complete the development of fully vetted FHIR to CDASH mappings for seven core domains (AE, CM, DM, MH, Procedures and VS). The mappings will be jointly balloted by CDISC and HL7 using their respective governance processes. Based on gaps identified, CDISC standards may be enhanced/expanded to account for RWD digital sources (e.g., EHRs, ePROs, TeleHealth, etc.) and to improve interoperability.

The mappings will be published as both a FHIR implementation guide and as part of the CDISC Library. Both representations will provide free access for all. Making the mappings available via the CDISC Library API permits software tools to use them to automate eSource and other integration tasks.

The mappings will be developed using CDASH v2.1 and FHIR vR4 to include the relevant US Core Implementation Guide (IG) extensions. The US Core IG covers the ONC 2015 Edition Common Clinical Data Set (CCDS) and the proposed ONC U.S. Core Data for Interoperability (USCDI).

The project will collaborate with CDISC, Vulcan, PHUSE, TransCelerate BioPharma, and other groups to review the mappings for consistency and quality purposes as well as to create examples to aid implementers.

3e. Objectives/Deliverables and Target Dates

Map FHIR to CDASH/SDTM for AE, CM, DM, MH, Procedures and VS. Target ballot cycle: January 2020

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

Unknown

3m. External Vocabularies

Yes

3n. List of Vocabularies

CDISC Controlled Terminology

4a. Products

FHIR Extensions, FHIR Implementation Guide, FHIR Profiles, FHIR Resources

4c. FHIR Profiles Version

FHIR vR4

5a. Project Intent

Create new standard, Revise current standard, Implementation Guide (IG) will be created/modified

5a. Is the project adopting/endorsing an externally developed IG?

No

5a. Externally developed IG is to be (select one)

Endorsed

5a. Specify external organization

CDISC

5a. Revising Current Standard Info

FHIR vR4, CDASH v2.1

5d. Joint Copyright

No

6e. Is this a hosted (externally funded) project?

Yes

6f. Stakeholders

Regulatory Agency, Standards Development Organizations (SDOs)

6g. Vendors

Pharmaceutical, EHR, PHR

6i. Realm

Universal

7a. Management Group(s) to Review PSS

FHIR