Project Scope |
Provide community forums for presentation and discussion of RBQM-related topics to support industry education. Topics considered include: What are CtQs?, RBQM and Technology, Risk Assessments, Central Monitoring Analytics, QTLs, AI/ML, and RBQM-related change management. |
| Problem Statement |
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Industry wide, there is still a need for general education on RBQM – what it is, what are the components, how to effectively implement RBQM, etc. There is also a lack of feedback from the FDA on RBQM practices implemented, and, based on discussions with the FDA, there may be a need for education in collaboration with the FDA. |
| Problem Impact |
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Because of misconceptions and misunderstanding of RBQM, many companies have delayed implementation of RBQM practices. RBQM concepts have the possibility to meaningfully improve data quality and efficiency across many functions (data management, medical monitoring, clinical operations) and processes (e.g. administrative activities); however, due to misunderstanding of RBQM, many functions do not implement risk-based approaches. |
| Project Leads | |
|---|---|
| Ann Fleenor, Astellas | ann.fleenor@astellas.com |
| Jennifer Krohn, Gilead | Jenn.Krohn@gilead.com |
| Shawntel Swannack, Emmes | sswannack@emmes.com |
| Alex Pearce, PHUSE Project Assistant |
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| Objectives | Timelines |
|---|---|
| Produce a webinar series | Q4 2025 – Q4 2025 |
| Deliverables | Type of Deliverable |
| Challenges in Central Monitoring Implementation | White Paper |
| Defining Central Monitoring Value | White Paper |