Nonclinical Topics – Project Volunteer Board
Welcome! |
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Interested in joining one of the Nonclinical Topics Working Group Projects? The projects below welcome new volunteers. |
Project Description: This project will develop an initial, non‑exhaustive set of technical conformance rules for the FDA’s tumor.xpt specification. Since 1999, industry has been required to submit tumour data in this format alongside SEND datasets. However, unlike SEND – which includes CDISC‑provided conformance rules – tumor.xpt has no formal validation framework and cannot be checked using standard automated tools. Because tumor.xpt is not a CDISC standard, CDISC will not supply such rules, leaving industry to manually verify compliance with FDA requirements. This project will create the first validator rules that can be implemented within existing SEND verification tools, reducing manual review effort and improving the overall quality and consistency of tumor.xpt files. Automating these checks is expected to shorten preparation time, decrease sponsor–FDA back‑and‑forth, and provide clearer insight into potential issues. If adopted by the FDA, these rules could also streamline regulatory review by identifying format problems earlier. | Regular Project Meeting Day/Time:
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Project Description: This project will advance the Nonclinical Study Data Reviewer’s Guide (nSDRG) by incorporating feedback from public PHUSE review and stakeholders, while aligning it with updates to the FDA Technical Conformance Guide. It will also ensure continued consistency with the published CDISC SEND standards and clinical SDRG template developed by the Optimizing the Use of Data Standards Working Group. Because the SDRG is a recommended component of CDISC‑compliant submissions, the project aims to make its creation effective and practical. Key objectives include delivering an accessible template, providing clear guidance on expected content, and offering examples that illustrate how to address common data scenarios. As the work progresses, the team will explore approaches for generating the nSDRG, identify who is best positioned to author it, and assess its usefulness beyond FDA reviewers. The project will also consider how the nSDRG should evolve as organisations gain experience with SEND and as systems mature. | Regular Project Meeting Day/Time:
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Project Description: This project will run an annual survey to objectively capture insights that reveal meaningful trends and issues – positive and negative – across the PHUSE Community. The goal is to generate actionable information that supports continuous improvement in the development, use and governance of data standards. The survey will deliver value across key stakeholder groups. It will provide SDOs with clear, evidence‑based feedback to guide enhancements to their standards. It will give CROs, software developers and data service providers a structured channel to share practical recommendations informed by their extensive data management experience. It will also equip sponsors with insights into how to better leverage and optimise their SEND investments. | Regular Project Meeting Day/Time:
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