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Welcome!

Interested in joining one of the Data Transparency Working Group Projects? The projects below are currently calling for welcome new volunteers.

Project Scope:

The scope of this project is to identify a primary and back-up representative for each PHUSE regulatory referenced deliverable that will:

  • review updates to regulatory documents where PHUSE deliverables are referenced to ensure they are in alignment

  • identify any updates that are required due to updated regulatory documents

  • organise the updates, including addressing feedback from PHUSE members

  • discuss the updates with the ODS Working Group Leads to agree on the updates

  • oversee the updates and publishing of PHUSE deliverables

  • commit to serving as a representative for two years.

The project team will meet quarterly with the ODS Working Group Leads to discuss potential updates and their timing to avoid burdening the project team members and the regulatory authorities in reviewing the updated deliverables.

Current Status:

  • cSDRG/ADRG: Incorporate public rev feedback.

  • SDSP: Review/update template & CG: confirm reps.

  • Clarify PHUSE Reg Doc Rev Flow: trigger point for new guidance doc and yes criteria for collab partner rev.

Regular Project Meeting Day/Time:

  • Quarterly

Key Skills:

SDTM ADaM Implementation FAQ – Started Q2 2024

Project Scope:

The Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, NMPA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to:

  1. Collect frequently asked questions (FAQs) from Industry. If you have a question for the team, email workinggroups@phuse.global.

  2. Assess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required.

  3. Publish the FAQ and responses on Advance Hub database for helpful implementation/strategy information.

Current Status:

  • No update.

Regular Project Meeting Day/Time:

  • Bi-weekly: Tuesdays 3-4pm 15:00-16:00 GMT

Key Skills:

Management of ODS Regulatory Referenced Deliverables – Started Q2 2024

(currently being reviewed by WG Leads)