HL7 FHIR® R4 Implementation Guide: Single Institutional Review Board Project (sIRB), Edition 1- US Realm

DESCRIPTION

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.

 

See the specification at http://hl7.org/fhir/us/sirb/STU1

ALTERNATIVE NAMES

HL7 FHIR® R4 Implementation Guide: Single Institutional Review Board Project (sIRB), Edition 1- US Realm may also go by the following names or acronyms:

BENEFITS

• Facilitates expedited approval and improved timelines for study initiation and completion, rather than each site waiting for approval of a study by its local IRB before enrolling subjects using a single IRB review
• Enables improvements in the redundancy of effort, additional costs, and administrative burdens that often lead to delays and imbalances in enrollment of research participants in multi-site clinical studies.

IMPLEMENTATIONS/CASE STUDIES

• Academic Medical Centers (clinical sites),
• Electronic Data Capture vendors,
• eIRB System vendors,
• IRB accreditors,
• IRB Reliance Organizations,
• Commercial IRBs

RELATED DOCUMENTS

HL7 FHIR® R4 Implementation Guide: Single Institutional Review Board Project (sIRB), Edition 1- US Realm

STU DOCUMENTS

HL7 FHIR® R4 Implementation Guide: Single Institutional Review Board Project (sIRB), Edition 1- US Realm See the standard at http://hl7.org/fhir/us/sirb/STU1.

Expiration Apr 2025

TOPIC

• Regulated Studies

BALLOT TYPE

• STU

STATUS DATE

2023-04-20

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• Implementation Guide

STAKEHOLDERS

• Healthcare Institutions
• Pharmaceutical Vendors
• Regulatory Agency
• Standards Development Organizations (SDOs)

FAMILY

• FHIR

CURRENT STATE

• Active

REALM

• US Realm