Overview

This repo contains materials for the OpenRBQM Workshop run at Phuse EU Connect 2025 in Hamburg, Germany.

It is based on a previous workshop held ath the Phuse US Connect 2025 in Orlando

• OpenRBQM Home Page
• IMPALA Home Page
• Workshop Posit Cloud Project
• Workshop Slides

Relevant R Packages

• {ctas}
• {simaerep}
• {gsm.core}
• {gsm.kri}
• {gsm.mapping}
• {gsm.reporting}
• {gsm.simaerep}

Posit Cloud Setup

Workshop attendees can run examples in Posit Cloud by following these steps:

• Open Posit Cloud Project
• Log in/Create an Account
• Click on the 'assignment' to make yourself a copy
• Follow along with hands on exercises

Agenda

• 5 min - OpenRBQM/IMPALA - Jeremy Howells & Björn Koneswarakantha
• 10 min - RBQM Overview - Chris Wells
• 5 min - {gsm} modules and flagging methods Björn Koneswarakantha
• 15 min - Hands on - Analytics - Lawrence Dennison-Hall & Mariia Lapaeva
• 15 min - Hands on - Deep Dive - Björn Koneswarakantha
• 10 min - Introduction to statistical data monitoring and clinical trial anomaly spotter - Pekka Tiikkainen
• 20 min - Hands on - clinical trial anomaly spotter - Pekka Tiikkainen
• 10 min - Wrap-up and Buffer Time - Jeremy Howells

Objectives

• Understand what RBQM is and how it’s done
• Learn about open-source collaboration and contribution
• Learn how to evaluate KRIs using {gsm} on your own studies
• Learn abour statistical anomalies in clinical studies and how to detect them using {ctas}