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CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s fall virtual meetings. The broadcast is an opportunity for stakeholders to stay informed on what’s going on with the development of SEND and its use in regulatory submissions.

03 November, 2021 8:30 am – 12:30pm EDT

 
Agenda

8:30am – 9:00am Introductions – CDISC SEND Leadership Team

9:00am – 9:30am Overview of CJUG (CDISC Japan User Group) SEND Activities – CJUG Send Team Leader

Austin, TX and Nashville, TN – 21 Oct 2021 – CDISC has announced it will work with Research Electronic Data Capture (REDCap) on an initiative to pave the way for academic institutions and researchers to carry out more meaningful and efficient clinical research that has a greater impact on global health.
Austin, TX and Waltham, MA – 19 Oct 2021 – CDISC announced that it is collaborating with OpenClinica to improve data collection in clinical studies conducted by academic institutions and researchers with the goal of driving research forward.
Austin, TX – 01 Sep 2021 – CDISC and HL7 announced the release of the FHIR to CDISC Joint Mapping Implementation Guide , freely available on the CDISC and HL7 websites, to facilitate the use of electronic health record (EHR) data in clinical research. The Implementation Guide defines mappings between FHIR, HL7’s standard for exchanging healthcare information electronically and three CDISC Standards: CDASH (data collection), SDTM (data tabulation) and LAB (lab data exchange) to streamline the flow of data from EHRs to CDISC submission-ready datasets.
BRUSSELS, BELGIUM and AUSTIN, TX – 22 June 2021 – CDISC announced the release of a freely available standard that maps existing international standards to facilitate interoperability of data and metadata related to vaccine administration. Developed in partnership with the Global Information for Public Health Transformation (GIPHT), an initiative of the Learning Health Community, the Vaccination Administration Version 1.0 standard represents a minimum set of key data elements for electronically documenting vaccinations.
AUSTIN, TX – 01 June 2021 – CDISC is teaming up with Microsoft to develop the CDISC Open Rules Engine (CORE), open-source software that executes machine-readable CDISC Conformance Rules. The global clinical research community will be able to leverage the CORE software to test study data for conformance to CDISC standards as well as regulatory and sponsor-specific conformance rule sets.