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The Optimizing the Use of Data Standards Working Group has a new project FDA Requests Public Comment on CDISC Dataset-JSON Standard and is calling for volunteers!

The U.S. Food and Drug Administration (FDA) has recently published a Federal Register Notice exploring the potential adoption of CDISC Dataset-JSON v1.1 as a new exchange standard for electronic study data submissions potentially replace the SAS v5 XPORT Transport Format (XPT) in the long term.

The FDA is seeking comments on whether to accept Dataset-JSON for regulatory applications in the future, specifically regarding:

  • The risks and benefits of industry adoption of Dataset-JSON as a new exchange standard.

  • Any integration challenges with existing tools and systems.

PHUSE, given its expertise and commitment to advancing the implementation of data standards within the pharmaceutical industry, and its recent PHUSE/CDISC pilot, is launching a short-term project to collect and synthesize comments from its members on this Federal Register Notice.

Building on the PHUSE/CDISC pilot this is an opportunity to:

  • Influence the future of regulatory data submissions.

  • Share your expertise and perspectives on data standards.

  • Collaborate with fellow PHUSE members on a timely and impactful initiative.

  • Contribute to PHUSE's position on this important topic.

We are seeking volunteers to participate in this project.

The timeline for this project will be relatively short, aligning with the FDA's comment period. We anticipate the main activities to take place during May.

If you are interested in volunteering for this important project and contributing your expertise, please express your interest by completing this Working Group Project Membership Form.

Integration of Omics Data into Clinical Drug Development, a new project within the Emerging Trends & Innovation Working Group, is calling for volunteers. 

Omics data has the promise of bringing precision medicine and targeted drug discovery to life. However, its use in clinical drug development has been quite limited due to challenges that span technical, practical, ethical and regulatory domains. The team proposes an initial short-term smaller scope of the WG focused on BioCompute and its implementation. This would ensure a focused short to mid-term delivery. The scope would entail: 

  • Establishing best practices when working with BioCompute 

  • A guide for creating and validating BioCompute Objects 

  • Submission considerations for BioCompute Objects 

  • Sharing of BioCompute Objects across the industry.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 May.

The Kick-Off Meeting for this project will be held 6 May 10:00 (EDT) / 15:00 (BST) / 16:00 (CEST)

If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. 

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