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Entries form Project Insight

The current list of active projects on Project Insight is here

Projects Where BR&R Is Sponsor


NumNameSponsor/CoSponsorDescriptionProject FacilitatorSD ApprovalTSC ApprovalStatusNext MilestoneCommentActionCo-Chair

1,687

Integrated Trial Matching for Cancer Patients and Providers (PSS in Jira)Sponsor(s):
Biomedical Research and Regulation Work Group
This use case aims to make clinical trial participation equitable and easy for all patients and providers. Our approach is to develop mCODE-based open data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching...Caroline PotteigerAwaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

Sep 1, 2021

OK

1,665

5-year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration Date: 2021-06-09 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifactBRR Co-ChairsAwaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

May 1, 2021

To be reaffirmed
Boris

1,664

Reaffirmation of HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration Date: 2021-12-02 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifactBRR Co-ChairsAwaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

Sept 1, 2021

To be reaffirmed
Boris

1,663

5-year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration Date: 2021-12-02 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifactBRR Co-ChairsAwaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

Sept 1, 2021

To be reaffirmed
Boris

1,662

5-year expiration approaching: HL7 Version 3 Standard: Drug Stability Reporting (eStability), Release 2 (revision of ANSI/HL7 V3 DSR, R1-2005)Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration Date: 2021-08-22 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifactBRR Co-ChairsAwaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

May 1, 2021

Withdrawal requested
Boris

1,644

FHIR Implementation Guide for Transfusion and Vaccination Adverse Event ReportingSponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Patient Care Work Group, Public Health Work Group
The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations. There are two sets of profiles with the first set intend...Jean DuteauAug 7, 2020Sep 7, 2020Active Project (Resources assigned to pjt)

May 1, 2021

OK

1,636

FHIR to CDASH (PSS in Confluence)Sponsor(s):
Biomedical Research and Regulation Work Group
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, a...Rhonda Facile, Mike HamidiAug 16, 2020Aug 31, 2020

Jan 1, 2021

OKFeb 2021: Working through ballot commentsHugh

1,574

BRIDG 2020 Update (PSS in Confluence)Sponsor(s):
Biomedical Research and Regulation Work Group
Changes are made to the BRIDG model based on work planned by FDA and NCI - we know there will be work, but at this point we are unclear what that will be.Smita HastakOct 29, 2020Nov 11, 2019Active Project (Resources assigned to pjt)

May 1, 2020

Inactive

1,540

Single Institutional Review Board Project (sIRB) (PSS in Confluence)Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Interoperability Council Work Group, FHIR Infrastructure Work Group, FHIR Management Group
We will develop, test and evaluate data standards to move data and documents from clinical research sites to a single ethics review board in support of the 'NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.' The scope o...

Anita Walden and Ed Hammond

James Topping

Nov 22, 2019Dec 2, 2019

Active Project (Resources assigned to pjt)

Jan 1, 2021

Report due Feb 23rdRevise datesHugh

1,537

Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) (PSS in Confluence)Sponsor(s):
Biomedical Research and Regulation Work Group
The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange ...Mary Ann Slack; Boris BrodskyAwaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

Jan 1, 2020

OK

Going for ballot

Revise datesSmita

1,531

BRIDG 5.4 (BRIDG 5.3 Update) (PSS in Confluence)Sponsor(s):
Biomedical Research and Regulation Work Group
The scope of this project is to ballot a new release of BRIDG.Ed Helton (BR&R co-chair, NCI)Awaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

May 1, 2020

Inactive

1,503

BRIDG Model Update (BRIDG Release 5.3/HL7 BRIDG r5) (v20190115v2.doc)Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Orders and Observations Work Group
The scope of this project is to ballot a new release of BRIDG.Ed HeltonFeb 3, 2019Feb 11, 2019Informative - Reconcile

Sep 1, 2019

CompleteChange statusSmita

1,426

Women’s Health Technology Coordinated Registry Network (CRN)Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Interoperability Council Work Group, Orders and Observations Work Group
The federal Women’s Health Technologies (WHT) Coordinated Registry Network (CRN) project will create a set of linked registries focused on women’s health, using data elements and measures expressed in standard structured definitions with the c...Nagesh Bashyam / Martha Velezis / Rachael Roan/Richard BallewJul 30, 2018Sep 27, 2018Informative - Reconcile

Sep 1, 2019

Needs reconciliation uploading

(and its an STU not normative)

With Dragon - no time until MaySmita

1,425

CDISC Lab Semantics in FHIR (PSS in Confluence)Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Orders and Observations Work Group
Biomedical Research and Regulation (BR&R) and Transcelerate Biopharma (TCB)are assessing the use of FHIR resources to exchange clinical trial lab data. The Clinical Data Interchange Standards Consortium (CDISC) Lab Model and LB domain standards curren...Julie Evans,Hugh GloverAug 3, 2018Feb 18, 2019STU - Test Period/Accepting Comments

Sep 1, 2022

OK

1,424

Common Data Model Harmonization (CDMH) - FHIR Implementation GuideSponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Interoperability Council Work Group
The nation is reaching a critical mass of Health IT systems (EHRs, Data Warehouses etc.) that comply with data and vocabulary standards. The wide deployment of Health IT systems has created unique opportunities for providers, provider support teams, healt...Nagesh BashyamJul 24, 2018Sep 27, 2018STU - Reconcile

Sep 1, 2019

STU complete - what now?With Dragon - no time until MaySmita

1,416

Exploration of FHIR resources to support of IDMP 11238/19844 Substances Standard and Technical Specification.Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Orders and Observations Work Group, Pharmacy Work Group
This project will develop FHIR resources to support the content of the revised ISO 11238 IDMP Substance standard and its ISO/TS 19844 Technical Specification, and other domain areas with similar requirements. These cover a very detailed representation of ...Mary-Ann Slack (FDA), Panagiotis Telonis (EMA), Boris Brodsky (FDA)Awaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

Sep 1, 2018

Replace with general MedDef resource development project

Progressing to TSC

Smita

1,367

FHIR resources to support IDMP 11615 Product StandardSponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Orders and Observations Work Group, Pharmacy Work Group
This project will commence the development of FHIR work and probably logical models and resources or possibly profiles, to support the content of the ISO 11615 IDMP Product standard, and other domain areas with similar requirements.Panagiotis Telonis (EMA), Boris Brodsky (FDA)Dec 29, 2017Mar 5, 2018Active Project (Resources assigned to pjt)

May 1, 2018

Replace with general MedDef resource development projectProgressing to TSCSmita

1,339

Structured Product Labeling (SPL R9)Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Orders and Observations Work Group
The scope of this project is twofold: a) to describe the use of SPL Release 9 as the data exchange format to support PQ/CMC (Pharmaceutical Quality (PQ)/Chemistry, Manufacturing and Controls (CMC)) information in Module 3 of the CTD which currently is be...Vada Perkins (ID), Panagiotis Telonis (EMA), Mary-Ann Slack (FDA)Awaiting ApprovalAwaiting ApprovalActive Project (Resources assigned to pjt)

Jan 1, 2018

Obsolete

This was replaced by #1537

Vote to remove

Need O&O to agree

Ask Dave Hamil to remove

Boris

1,229

Structured Product Labeling for Food (SPL R8)Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Patient Care Work Group
The purpose of this project is to ensure that the structured product label V3 artifact includes all of the necessary data elements for food and dietary supplements. The goal is to allow the electronic transmission of foods, branded food products, dietary ...Vada Perkins and Elaine AyresJan 21, 2016Feb 1, 2016Active Project (Resources assigned to pjt)

May 1, 2016

Obsolete

This is Food only

Vote to remove

Need Patient Care to agree

Ask Dave Hamil to remove

Boris


Projects Where BR&R Is Co-Sponsor

NumNameSponsor/CoSponsorDescriptionProject FacilitatorSD ApprovalTSC ApprovalStatusNext Milestone

1,433

Patient Reported Outcomes (PRO)Sponsor(s):
FHIR Infrastructure Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Orders and Observations Work Group, Patient Care Work Group
Patient Reported Outcomes (PROs) can be used to inform the clinical management of individuals, shared decision-making, patient self-management, care planning, goal setting and attainment, and to inform patient-centered outcomes research. However, health s...FHIR-InfrastructureAug 9, 2018Sep 27, 2018STU - Reconcile

Sep 1, 2020

1,422

FHIR Resources for Evidence-Based Medicine Knowledge Assets (EBMonFHIR)Sponsor(s):
Clinical Decision Support Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Clinical Quality Information Work Group

Brian AlperJun 4, 2018Jun 22, 2018Active Project (Resources assigned to pjt)

Sep 1, 2020

1,390

Structured Data Capture Update (SDC)Sponsor(s):
FHIR Infrastructure Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Financial Management Work Group, Orders and Observations Work Group, Patient Care Work Group
This project will involve updating the existing Structured Data Capture (SDC) Implementation Guide. Specific objectives include: - Aligning the implementation guide with the forthcoming R4 version of FHIR - Updating profiles to reflect the experience of...Lloyd McKenzieJan 29, 2018Mar 5, 2018STU - Reconcile

Sep 1, 2020

1,292

Specimen DAM UpdateSponsor(s):
Orders and Observations Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group
Comparison of conceptual model components defined in the first release of the Specimen DAM (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=394)were compared to the biologic specimen part (and its ancestor classes) of the BRIDG 4.0 mod...Riki MerrickOct 25, 2016Nov 17, 2016Informative - Request Publication

Sep 1, 2022

1,265

Data Access Framework (DAF) FHIR Implementation GuideSponsor(s):
FHIR Infrastructure Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Infrastructure and Messaging Work Group
This updated DAF project scope statement is to 1. Update existing DAF IG based on feedback from Argonaut 2. Updates to account for FHIR STU changes 3. Map for 2015 CCDS data elements 4. Propose new resources or modifications to resources to enable Researc...Jonathan ColemanJul 23, 2016Aug 1, 2016STU - Expired Test Period

May 1, 2019

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