The CSS will feature three workshops:
Sunday, March 4th 19:30 - 21:00 Room Spring
Linked Data for Clinical Trials: An Interactive, Hands-on Workshop – SOLD OUT
Tim Williams, UCB, Johannes Ulander, S-Cubed
In this hands-on workshop you will diagram relationships for clinical trial processes and data, then convert your white-board "graph" to Linked Data. Linked Data is increasingly recognised as a potential solution for many of the data-related challenges facing the pharmaceutical industry.
Linked Data represents real-world concepts and relationships in a machine-readable, extensible, future-proof format. Classification (ontologies), rules, code lists, standards, and metadata become integral to the data, breaking down traditional data silos. This introductory workshop will provide you with the basic knowledge and tools to launch your own exploration of this technology or participate in a PhUSE project. No previous experience is assumed.
You must bring a laptop with remote desktop capability and attend a preparatory webinar in advance of the conference.
Monday, March 5th 18:30 - 20:00 Room Spring
GitHub Environment: From Whitepaper Targets (TFL) to Shareable Scripts
Hanming Tu, Frontage
This session will explore the repository in the GitHub environment, looking at the targets (TFL) defined in the whitepapers, the scripts developed for the targets, the guidelines for qualifying scripts, the steps for contributing scripts and a new way of accessing, sharing and executing scripts with script metadata using R PhUSE package.
Monday, March 5th 18:30 - 20:00 Room Fenton
Maintaining the Clinical & Nonclinical Study Data Reviewer's Guides - SOLD OUT
Jane Lozano, Eli Lilly, Debra Oetzman, Instem
Several years ago, a PhUSE clinical team created a template for cSDRG. A nonclinical PhUSE team formed and used that template as a starting point for what is now known as the nSDRG. Now, as the use of these SDRGs has evolved and become a critical piece of the review process – to the point where links to the templates are included in the FDA Technical Conformance Guide – the clinical and nonclinical teams are coming together for a workshop at the PhUSE CSS in March, to mutually examine and agree on the processes that should be aligned surrounding maintenance, access, and communication of these important templates, to the general public.
This workshop will focus on that alignment, with a goal to agree on common approaches and communication mechanisms. This will improve and clarify our direct support to be consistent with the TCG and provide a valuable feedback mechanism for the public on these “preferred” templates for the FDA. The approaches developed for maintenance and communication should be validated afterward as a model for management of aDRG and SDSP templates, and possibly other PhUSE deliverables referenced by the FDA or other regulatory organizations.
Topics will be:
- Maintenance of the SDRG packages
- process for keeping current with the TCG
- process for managing public comments/suggestions
- resourcing the teams
- Communication of the SDRG packages to the public
- easy-to-find single source
- maintained for current status
- provides a method for public feedback
Workshops are free to attend, but places are limited. Pre-registration is required, sign up for the workshops during event registration.