Risk Based Quality Management – Project Volunteer Board

Interested in joining one of the Risk Based Quality Management Group Projects? The projects below welcome new volunteers.

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.

Current Status:

• Regrouped with new leads Ann, Shawntel and Jennifer. 

• Reviewed and edited current member roster and email distribution list.

• Gathered several Community forum topics as part of RBQM education focus.

Regular Project Meeting Day/Time:

• Bi-weekly: Wednesdays 17:00-18:00 GMT

Key Skills: (currently being reviewed by WG Leads)

Project Scope:

We propose beginning this project by identifying CtQ factors via a risk assessment process (characterising risk including assessment and mitigation/risk reduction strategies), which would include identifying trial-level QTLs that support CtQ factors. 

Current Status:

• Form sub-teams.

• Present at SCOPE and the US Connect.

• Complete first wave of sub -team work.

Regular Project Meeting Day/Time:

• Bi-weekly: Wednesdays 14:00-15:00 GMT

Key Skills: (currently being reviewed by WG Leads)

Project Scope:

To discuss and focus on a robust strategy/process and best practices for:

• Identifying critical items

• Risk Based data review approaches

• Risk Based Monitoring approach strategy (tSDV/tSDR)

• Usage of analytical tools and methods for data review & central monitoring, including limitations on (statistical) methodologies

• Identification of thresholds or equivalent on limited patient data

• Targeted medical review

• Strategy to adequately anticipate on highly dynamic data

• Establish links with the other work streams on FIH/small studies focus

Current Status:

• Discuss sub-group discussions/outcomes in all -team meeting.

• Regrouping where needed.

Regular Project Meeting Day/Time:

• Bi-weekly: Wednesdays 14:00-15:00 GMT

Key Skills: (currently being reviewed by WG Leads)

Project Scope:

We propose forming an Open-Source RBQM Working Group and an associated development sub-team.

Open-Source RBQM Working Group – A Working group that will discuss open-source projects related to RBQM. This will be a cross-functional team that will consider how open-source solutions can be developed using RBQM best practices. Monthly meetings will include discussion of RBQM software best practices, design discussions for development team deliverables and demos of RBQM tools developed.

RBQM Development Team – This team will focus on the pre-competitive co-development of RBQM centralised monitoring tools. The primary focus will be on R package development, though other technologies may be considered. The team will start with a focus on creating reports and interactive graphics related to centralised statistical monitoring (e.g. digit preference charts, missing data analysis, fraud detection). All development will be done using GitHub. The team will meet every other week in 2024. 

Current Status:

• Connecting with other Working Groups.

• US Connect Workshop.

Regular Project Meeting Day/Time:

• Monthly: Wednesdays 16:00-17:00 GMT

Key Skills: (currently being reviewed by WG Leads)