Pre-registration required and is an additional fee.

*Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory.

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This full-day, hands-on short course walks participants through an exercise for Risk Based Quality Management (RBQM) implementation from study startup to close-out, using a cloud-based RBQM technology. From protocol design to centralized monitoring and database lock preparation, participants will see how ICH E6(R3)/E8(R1) principles can be translated into practical applications and workflows, then practice them on example study data.

The key activities will all be hands-on within the platform, and will include: (1) Discussion of Quality by Design aspects; (2) Identify Critical to Quality (CTQs) and associated risks based on a protocol; (3) Configure key risk indicators (KRIs) and associate risks; (4) Risk reviews and Exporting IQRMP (5) Operational central monitoring such as analytics/CSM, triage issues; (6) Data quality review and audit trails.

Participants will be provided a demo study protocol, quick start instruction guide and cheat sheet, and will be guided through each activity before they attempt each themselves in mock scenarios. Participants will be encouraged to apply the techniques to study formats or TAs they are familiar with, asking questions or testing various use cases with the instructors. Within the platform, the demo study will have simulated study data, to provide participants with practical scenarios, not just theoretical.

The course will highlight how such a technology can be applied for: optimizing data quality; reducing study setup and close out timelines; reduce site and operations team burden; preserve patient safety. We will also discuss the RBQM applications for early-phase and healthy-volunteer studies vs. scaling for multi-country, decentralized, or adaptive designs.

Participants will leave being able to work in a typical RBQM environment, be compliant to the QbD and RBQM requirements of ICH E6(R3), and improve data quality and patient safety within the context of RBQM, across all types and forms of clinical studies.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.