FAIR DATA PRINCIPLES
The use of these mappings will ensure that FAIR data management and stewardship principles (Findability, Accessibility, Interoperability, and Reusability) are followed to the benefit of all stakeholders.
The FAIR principles emphasize machine-actionability (i.e., the capacity of computational systems to find, access, interoperate, and reuse data with none or minimal human intervention) because humans increasingly rely on computational support to deal with data as a result of the increase in volume, complexity, and creation speed of data.
CDISC STANDARDS DEVELOPMENT PROCESS
DATA HARMONIZATION & MAPPINGS
Harmonization of a set of 20 core data elements based on the European eHealth Network – Guidelines on verifiable vaccine certificates – basic interoperability elements.
These elements align with:
• US CDC Endorsed Data Elements
• EU Digital COVID Certificate
• WHO Interim Guidance for Developing a Smart Vaccine Certificate (SVC)
• CDISC – International Organization for Standardization and Governance
• HL7-FHIR – Electronic Healthcare Records Exchange
• ISO Standards – International Organization for Standardization
• ISO 8601 – Date and Time standards
• ISO 3166 – Country Codes
• IDMP – Identification of Medicinal Products standards
• ICD 10/11 – Classification of Diseases
• SNOMED CT – Healthcare Terminology
• WHODrug – Standardized Drug Information
• Anatomical Therapeutic Chemical (ATC) classification system