Working Group seeks help across a number of projects

The PHUSE Optimizing the Use of Data Standards Working Group is looking for volunteers to help across a number of its projects. 

CDISC Implementation Primer - 

  • This project will identify needs of new CDISC implementers with an additional focus on academia and technology providers. A "CDISC Primer" (e.g. Wiki, White Paper, slide deck, quickstart, guides, etc.) will be developed that addresses these needs and made freely available to the public.

Industry Experiences Submitting Standardized Study Data to Regulatory Authorities - 

  • FDA & PMDA require standardised study data for certain regulatory submissions. This project aims to provide a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc.  

SDTM ADaM Implementation FAQ - 

  • This project aims to collect frequently asked questions (FAQ) from the industry via a form on Wiki or PHUSE public events to assess the appropriateness of a question, develop & review response, collaborate with CDISC/FDA for clarity if required. To then publish the FAQ and response on Wiki database for helpful implementation/strategy information. 

If you are interested in helping with any of these projects, contact Jane Lozano lozano_jane_a@lilly.com or Lisa Brooks lisa@irisstatcomp.com. Visit the Call for New Projects & Leaders page for further information. 

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Tags: Partnerships and CollaborationsVolunteeringWorking Groups

Categories: PHUSE Blog

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