Interoperability Specification

IS 158 - Clinical Research Interoperablity Specification

The Clinical Research Interoperability Specification covers clinical research in all its forms as it interoperates with healthcare systems, particularly EHRs. The specification spans two industries, healthcare and clinical research, and incorporates standards from healthcare (HL7 and IHE) and research (CDISC). The design leverages existing HITSP constructs and communication methodologies where applicable, and lays out new constructs as needed. The design also leverages the current players in the clinical research industry such as Electronic Data Capture (EDC) systems and research registries.

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Construct	Title / Version	Referenced by	Status	Document Access
IS 158	Clinical Research Interoperablity Specification Version:1.0	IS 158 V:1.0	Released (Panel Approved)	DOWNLOAD

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Reference Documents

Acronyms
AHIC Use Cases
Conventions (naming and numbering)
Glossary
Harmonization Framework
Interoperability Specifications Overview