CDISC Standard

CDISC Standard

A proposed uniform CDISC standard intended to address the life-cycle of a clinical trial (protocol representation, capture of source data, submission of the data to the FDA and archiving), using a set of fully integrated and consistent models, terms and controlled vocabularies derived from the current set of CDISC standards.
References in periodicals archive ?
Another important CDISC standard is the Study Data Tabulation Model (SDTM), a standardized representation for clinical trials observations using a set of standard data variable names and table structures.
We are impressed by WIL's commitment to create more value for their clients through these enhancements and as the leading provider of SEND solutions, with more than 30 licensed sites in 11 countries, we are especially encouraged to see WIL supporting a critical FDA-adopted CDISC standard in preclinical.
OTCQX: DTRK), a leader in developing cloud-based, unified eClinical technologies and delivering related services for the clinical trials industry, today announced the addition of the CDISC Standard for Exchange of Nonclinical Data (SEND) Registered Solutions Provider to existing CDISC registrations.
They invested significant in-kind resources to remap the retrospective data to the new format that is now the CDISC standard.
This environment will enable FDA pharmacologists / toxicologist reviewers and statisticians to access, manipulate, and analyze nonclinical regulatory submissions in electronic formats including the CDISC Standard for the Exchange of Nonclinical Data (SEND).
CDASH is the CDISC standard for case report forms (CRFs) that is harmonized with SDTM and other CDISC standards.
Late last year, FDA issued a mandate that studies starting after December 17, 2016, must be submitted electronically and in conformance with CDISC standards.
CEO of Formedix, Mark Wheeldon, said : 'By collaborating with OmniComm, not only can our customers take advantage of Formedix's ability to reduce study specification times by over 60% but, with this new level of integration, all customers can benefit from automation from vendor neutral CDISC standards on an even greater scale.
The adoption of CDISC standards has greatly helped this situation by creating several formats to facilitate data exchange.
CDISC standards are vendor-neutral, platform-independent, and freely available via the CDISC website.
Kanevsky created an open source, freely available toolkit that enabled the implementation of CDISC standards, which revolutionized the way the life-sciences industry exchanges clinical data.