IS 158 - Clinical Research
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.