2023年6月22日 · MB domain scope broadened to include all detection, identification, quantification, and other characteristics assessments of non-host microorg, via direct detection methods and indirect, induced-host/subject immune response. IS domain scoped for any antigen-induced subject immune response, not restricted to study therapy.

The current Immunogenicity Specimen Assessments (IS) domain in the SDTMIG v3.4 is designed to represent data pertaining to specimen-based assessments that measure the “presence, magnitude and scale of the immune response upon an antigen stimulation or encounter.”

2024年7月1日 · The global clinical research community will be able to leverage the free and open CORE software to test study data for conformance to CDISC standards as well as to regulatory and sponsor-specific conformance rule sets. The CORE Project objectives are to:

CDISC Conformance Rules are an integral part of the CDISC Foundational Standards and serve as the specific guidance to Industry for the correct implementation of the Standards in clinical studies. The overall goal of the CORE (CDISC Open Rules Engine) Project is to deliver a governed set of unambiguous and executable Conformance Rules

CDISC (Clinical Data Interchange Standards Consortium). The CDISC vision is ʻto inform patient care and safety through higher quality medical researchʼ. CDISC is a standards developing organization. It is global, open, multidisciplinary, vendor-neutral, and non-Current status and future scope of CDISC standards profit, and it was founded in 1997.

The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and to improve medical …

The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.1.

There is a unique opportunity for CDISC to broaden the scope of its suite of data standards to accommodate and connect with RWD to better facilitate RWD sharing. We believe that CDISC standards can provide FAIR structure and semantics for common clinical concepts and domains and help bridge the gap between RWD and clinical trial–generated ...

These study data standards were developed as part of a collaboration between FDA, the nonprofit Clinical Data Interchange Standards Consortium (CDISC), and other stakeholders. Currently supported...

The purpose of this visual is to share current timelines and the proposed, high-level scope for CDISC Foundational Standards in development. The timelines and scope below are updated at the start of each quarter as standards progress through the CDISC Standards Development Process described in COP-001.