= Clinical Data Acquisition Standards Harmonization
Synteract assisting with CDASH
, CDISC's initiative to create a global data set library
Veristat is a CDISC Registered Solutions Provider in the following CDISC models: Trial Design, CDASH
, SDTM, ADaM, and Define.
On October 1, 2008, CDASH
released the first 16 common CRF streams (or domains) for use by the pharmaceutical industry.
initiative is an FDA Critical Path Opportunity that seeks to enable standardized collection of clinical research data at investigative sites.
She participated in the organization's Clinical Data Acquisition Standards Harmonization (CDASH
) initiative to define industry-standard case report forms, serving on the CDASH
Core Leadership Team and leading the Prior and Concomitant Medications and ECG sub-teams.
Session 5, 9:00: How to Go Effectively from Data Collection in CDASH
to Submission in SDTM: The need for an eCRF library, Isabelle de Zegher, Worldwide Senior Director Technology Integration & Data Standards
Leading EDC and CDM Vendor Adds Preconfigured Forms Built on CDISC's Industry Standard CDASH
to Increase Efficiencies and Trial Quality for Sponsors and CROs
As part of its continuing commitment to reducing clients' trial costs, DATATRAK has designed a study library using the CDISC CDASH
Further enhanced the standards in DATATRAK's growing library, which now includes the HL7 import of ECGs and CDISC SDTM data export, XML export to E2B in the Safety Export, use of CDISC and CDASH
field naming and exports using the CDISC Study Data Tabulation Model (SDTM)
Since the CDASH
standard is harmonized with the CDISC Study Data Tabulation Model (SDTM), the content standard for regulatory submission of case report form tabulations referenced in FDA e-Submission Guidance, use of CDASH
Through the Connectathon, we can clearly show that Prism's interoperability and compliance with IHE profiles, including CDASH
and RFD, has removed significant integration barriers that would otherwise have to be dealt with on site, at the customer's expense.