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Section 1c: FHIR®
Section 3: Implementation Guides

HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1

DESCRIPTION

FHIR provides an effective standard for sites and sponsors to utilize in exchanging clinical research laboratory data. The end-to-end process includes site data storage, site data preparation/transformation, production of FHIR format files, transformation from FHIR to CDISC laboratory data standards, and consumption of data by sponsor systems. This implementation guide focuses on mapping laboratory data from FHIR to CDISC.

ALTERNATIVE NAMES

HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1 may also go by the following names or acronyms:

"HL7 FHIR® IG: CDISC Lab Semantics, R1", "CDISC SDTM and CDASH mapping to FHIR for laboratory data", CDISC LAB IG

BENEFITS

  • Supports the exchange of laboratory information between data providers and clinical research sponsors.
  • Enables translation of FHIR elements into elements that are more familiar to research sponsors and are part of their existing infrastructure for analysis and regulatory reporting (i.e., CDISC SDTM and CDASH domain variables).

IMPLEMENTATIONS/CASE STUDIES

  • SCDM using this standard to define guidance for setting up FHIR servers for clinical research laboratories who send data to research sponsors.
  • Eli Lilly and Co. using this for local laboratory clinical research data.
  • MSK-CC and Dana Farber for exchange of laboratory data for oncology studies.

DEVELOPMENT BACKGROUND

A cross-industry effort began in 2017, to improve clinical research sponsors' ability to consume data in the FHIR standard. The team participated in multiple connectathons and worked together to harmonize the standards.

RELATED DOCUMENTS

HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1

STU DOCUMENTS

HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1 Please see the resource detail for link and download instructions. Expiration Aug 2022

TOPICS

  • Laboratory
  • Regulated Studies

BALLOT TYPE

  • STU

STATUS DATE

2020-08-27

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPE

  • Implementation Guide

STAKEHOLDERS

  • Clinical and Public Health Laboratories
  • Health Care IT Vendors
  • Pharmaceutical Vendors
  • Regulatory Agency
  • Standards Development Organizations (SDOs)

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • Universal