Date and Time: TUE 21 July 2020 11:00 AM - 12:30 PM Eastern US Standard Time
Introducing the CDASH eCRF Project
CDASH establishes the metadata standards for clinical data collection. Organizations across the industry use CDASH when developing electronic CRFs (eCRFs) in electronic data capture (EDC) systems, a process that can be complex and costly. To facilitate this process, CDISC has initiated the CDASH eCRF Project to develop machine-readable, visual representations of case report form layout based on the CDASHIG v2.1 . These eCRFs will be freely available on the CDISC website. CDISC Member, Formedix, is donating the use of the Formedix-On tool to develop and render the eCRFs. Join us as we provide a project update and lay out steps for further development.
CDISC Standards for Animal Rule Studies
Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide - Animal Rule ( SENDIG-AR ) describes how to represent data in studies, which use FDA regulations commonly known as the Animal Rule . The Animal Rule provides a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.
The SENDIG-AR v1.0 includes new domains and variables necessary to represent the unique concepts in support of submission of data from AR studies. Join us as we discuss considerations in developing such an implementation guide, including the changes required to SEND and SDTM to support submissions under the AR.
Presenters:
Alana St. Clair, Project Manager, CDISC
Dan Crawford, Senior Director, Vault CDMS Strategy, Veeva Systems
Jon Neville, Sr. Standards Developer, CDISC