CDISC

Background

CDISC stands for Clinical Data Interchange Standards Consortium, a standards developing organization (SDO) that has developed data standards for clinical and translational research for over 20 years. Its primary goal is to “enable information system interoperability to improve medical research and related areas of healthcare.” If applied early in the research phase, this standard has been authorized to cut overall resource requirements by 60%. CDISC defines the controlled terminology for the Study Data Tabulation Model (SDTM) and Clinical Data Acquisition Standards Harmonization (CDASH), providing extensible lists of controlled terms designed to harmonize data collected across the submission through a model, HL7 standard, and is the process to becoming an ISO/CEN standard.

CDISC standards are required for submission to the FDA, Japan PMDA, one of the only standards recognized by China NMPA, and can be used for patient-level data submission to EU EMA. It serves as the hub for cross-industry standards initiatives and is broadening the harmonization of clinical research information standardization.

HL7

HL7 refers to Health Level Seven, a set of international standards for the transfer and administrative data between software applications that primarily specifies a list of standards, guidelines, and methodologies by which healthcare systems can communicate with each other. HL7 contains 6 primary standards, each is Version 2.x Messaging Standard, Version 3 Messaging Standard, Clinical Document Architecture (CDA), Continuity of Care Document (CCD), Structured Product Labeling (SPL), Clinical Context Object Workgroup (CCOW). Other standards include Fast Healthcare Interoperability Resources (FHIR), Arden Syntax, Claims Attachments, Functional Specification of Electronic (EHR) / Personal Health Record (PHR) systems, and GELLO.

Tools

BioCompute Objects follow CDISC standards.