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 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:
Key Skills:
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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:
Key Skills:
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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:
Key Skills:
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