The long-standing relationship between PHUSE and CDISC has been greatly celebrated for the past 10 years. Our collaboration has played a crucial part in the implementation of standards, with CDISC developing these standards and the PHUSE Community offering invaluable feedback to help implement them.
Having CDISC members involved in PHUSE projects gives the PHUSE Community an opportunity to work with standards experts on the implementation of data. Many members of the PHUSE Community are users of clinical data standards published by CDISC in their day-to-day work.
By collaborating, the PHUSE Community can provide feedback and influence the available standards. As science progresses and approaches change, there is a need for new requirements and extensions to the existing standards.
CDISC is always eager to learn which topics are of most interest to the PHUSE Community and the PHUSE Working Groups are helping CDISC to understand where normative standards are going to be needed so CDISC can prioritise the development of these standards.
Watch the on-demand recording of the joint PHUSE and CDISC Webinar over on the PHUSE Engagement Hub find out more about the partnership!
Recent and Ongoing Collaborations
Analysis Results Metadata
PHUSE has been working on white papers for safety analytics since the beginning of the CSS – as published on the website – first as part of the Standard Analyses and Code Sharing Working Group and now as part of the Safety Analytics Working Group. These educational resources include examples of displays for implementers.
The PHUSE work was instrumental in informing the scope and approach of the Analysis Results Standards.
SDTM/ADaM FAQ
This long-running project in the PHUSE Optimizing Data Standards Working Group, brings together experts to answer SDTM and ADaM implementation questions and how this relates to submissions. In 2022, there were two Expert Answers to Community Questions events, with panellists from across industry, the FDA and CDISC. Standards experts from CDISC ensure correct guidance and give insight into issues arising in the industry.
The FAQ highlights where more guidance is needed in future versions of the standards to help implementation and avoid misinterpretation of the CDISC guides.
Partner Event at the US Connect 2022!
Thank you to everyone who joined us at the CDISC Partner Event in Atlanta, 3 May 2022.
CDISC hosted a special “In The Room” session, where presenters shared information and received feedback on CDISC CORE and Analysis Results Metadata.
CDISC’s Chief Standards Officer Peter Van Reusel and VP of Data Science Sam Hume began the session with an introduction to and demonstration of the CDISC Open Rules Engine (CORE). Bess LeRoy, Head of Standards at CDISC, and Bhavin Busa, VP and Head of Clinical Data Services and Operations at Vita Data Sciences, led an Analysis Results Standard workshop.
Attendees experienced a first-hand look and expert demo of the CORE open-source software. CORE executes machine-readable CDISC Conformance Rules retrieved from the CDISC Library. The global clinical research community can leverage the free and open Microsoft Azure-based CORE software to test study data for conformance to CDISC standards and to regulatory and sponsor-specific conformance rule sets.
This collaborative event was especially significant as the PHUSE Community are an important representation of the CDISC stakeholders, specifically with the CORE and Analysis Results Metadata projects. Having these discussions raises awareness of these projects and encourages feedback.
