Results and Lessons from the CDISC SDTM/ADaM Pilot Project
Get registered free… and listen to 1 hour Audio seminar by…
Cathy Barrows, Ph.D
Chris Holland
Edvard D. Helton, Ph.D
Tanyss Mason
Cathy Barrows, Ph.D
Chris Holland
Edvard D. Helton, Ph.D
Tanyss Mason
Program Content:
The CDISC SDTM/ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. The objective of the pilot project was to test how well the submission of CDISC-adherent datasets and associated metadata met the needs and the expectations of both medical and statistical FDA reviewers. In doing this, the project also assessed the data structure, resources and processes needed to transform data from a data source into the SDTM and ADaM formats, and to create the associated metadata. An additional goal was to produce a worked example implementation of the CDISC standards available at that time, including the Define.xml file.
This webcast will review the experiences, results, and learnings of the pilot project core team regarding the creation of a CDISC-adherent submission. Key aspects of the worked example will be highlighted, as will issues to keep in mind while exploring the example package (e.g., improvements or changes made in standards that are not addressed in the package).
Perspectives on the pilot project will be presented from CDISC and from the FDA, with a live question and answer session at the conclusion of the presentation.
Please note: The comments, statements and opinions attributed to regulatory review team members reflect views of those individuals and are conveyed as informal feedback by the pilot project team in the spirit of effective information sharing, and must not be taken to represent guidance, policy, or evaluation from the Food and Drug Administration.
Learning Objectives:
Gain an understanding of the logistics and processes used in the CDISC SDTM/ADaM pilot project
Hear key points deemed worthy of emphasis: the successes, the snags, and the solutions and work around that went into the successful completion of this pilot
Learn from the pilot project experience what things to consider when planning for your own CDISC submissions
Hear from FDA the positive effects of CDISC data standards on the submission and review process.
Implementing CDISC Submission Data Standards (audio seminar)
Presented By:
Rebecca Kush, Wayne Kubrick, Dan Godoy, Ed Helton
www.cdisc.org
Learning Objectives
Understand the current state of the CDISC SDTM and ADaM submission standards and the new define.xml standard
Gain insight on representative ways to effectively implement the SDTM and ADaM in Sponsor organizations
Understand some of the challenges and common questions that arise when implementing these standards
Learn about the experiences of Astra-Zeneca, a global pharmaceutical company in the process of adopting CDISC standards.
Free webinars on CDISC/SDTM/ADaM:
