Section 1c: FHIR®
Section 3: Implementation Guides
HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1
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.
HL7 FHIR® Implementation Guide: Clinical Research Sponsor Laboratory Semantics in FHIR, Release 1 may also go by the following names or acronyms:
- 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).
- 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.
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.
|Please see the resource detail for link and download instructions.||Expiration Aug 2022|
- Regulated Studies
RESPONSIBLE WORK GROUP
- Implementation Guide
- Clinical and Public Health Laboratories
- Health Care IT Vendors
- Pharmaceutical Vendors
- Regulatory Agency
- Standards Development Organizations (SDOs)