Safety Analytics – Project Volunteer Board

Interested in joining one of the Safety Analytics Working Group Projects? The projects below are currently calling for volunteers.

Project Scope:

This project team will create a users guide or White Paper with recommendations for analyses and displays associated with Hepatotoxicity, with a focus on Phase 2-4 clinical trials and integrated submission documents.

Current Status:

• Finalise Stage 1 white paper following public review.

• Get Stage 2 white paper ready for public review.

Regular Project Meeting Day/Time:

Key Skills:

Project Scope:

Interactive Analyses and Displays of laboratory data, applicable to Phase 2-3 clinical trials and integrated submission documents. Creating interactive analyses and displays would allow more options for the user without adding substantial volume and would provide a more user-friendly method for reviewing laboratory data. Multiple groups are involved in creating interactive displays or tools for clinical trial data, and having a deliverable outlining the desired features, with associated education on interpreting the analyses/displays, would help progress the overall efforts.

Current Status:

• Update to previous PHUSE deliverables, with considerations of interactivity.

Regular Project Meeting Day/Time:

Key Skills:

Project Scope:

Development and delivery of education relevant to clinical trial safety analyses, with a focus on Phase 2-3.

Current Status:

• Updates to safety library.

Regular Project Meeting Day/Time:

Key Skills: