A sub-set of work group members have volunteered to participate in a detailed review of the proposed site selection scoring tool. The review will include an examination of the site attributes, attribute scoring, and proposed use for assessing experienced research sites as well as de novo/research-naïve sites.

AQC Members can log into the AQC Knowledge Center and visit the meeting calendar to register. Contact us for information on establishing an AQC user account.

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Consortium members will continue to explore lessons learned from early QTL adopters at the next Community of Practice meeting on 13 July 2022. The topic of the meeting is Using KRIs as Companions to QTLs – Getting Earlier Signals of Risk QTL focusing on where QTLs work, and where they don’t as well as using KRIs as companions to QTLs.

AQC Members can log into the AQC Knowledge Center and visit the meeting calendar to register. Contact us for information on establishing an AQC user account.

Additional Resources

Applied Clinical Trials, Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 1), (Part 2), and (Part 3)

CTO Podcast Episode 34: Defining QTLs and KRIs that Detect Risks in a Timely Manner – Part 1 Relationship of QTLs & KRIs with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan

CTO Podcast Episode 35: Defining QTLs & KRIs that Detect Risks in a Timely Manner (Part II) — The Process of Defining QTLs with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan

CTO Podcast Episode 36: QTLs & Early Detection of Risk (Part III of the QTL Series) with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan

The post AQC QbD-RBQM-Quality Improvement CoP Group Exploring Current QTL Practices and Use of KRIs appeared first on Avoca, a WCG company.

Timely TMF completeness is one of the goals of a well-functioning TMF process. Timeliness is relatively easy to measure – but how do you measure whether the TMF is complete? Join us on June 14, 2022 at 11:00 am EDT as we discuss what works and some of the challenges with measuring completeness.

AQC Members can log into the AQC Knowledge Center and visit the meeting calendar to register. Contact us for information on establishing an AQC user account.

The post Is it possible to measure TMF completeness accurately? It may be worse than you think! appeared first on Avoca, a WCG company.

• Part 1 – Relationship of QTLs and KRIs

• Part 2 – Defining QTLs

• Part 3 – Methods for early detection of risk

WCG Avoca Quality Consortium (AQC) Members had an opportunity to discuss the recommendations with the working group at the AQC QbD – RBQM – QI Community of Practice meetings on June 8 and July 13, 2022.

AQC Members can log into the AQC Knowledge Center and visit the meeting calendar to register for upcoming meetings. Contact us for information on establishing an AQC user account.

The post QTL Working Group Publishes 3-part Series appeared first on Avoca, a WCG company.

1. Industry and regulatory trends such as increased patient engagement (ICH E8 R1), FDA Guidance on Patient-Focused Drug Development, and the move to an increased use of ePRO (electronic Patient Reported Outcomes) as part of implementation of approaches to decentralized clinical trials needed to be considered.
2. Consortium members identified gaps in the metric set – in particular around translation, eCOA helpdesk, and training processes – areas not covered in detail in earlier versions.
3. The eCOA Process Metrics Toolkit v2.0 was developed prior to consortium members discussing whether metrics included in metric toolkits should be designated as potential Key Risk Indicators to support Risk-Based Quality Management.

The work group followed the Metric Development Framework described in the White Paper: MCC’s Metric Development Framework: Defining Metrics That Answer Key Performance Questions [link] to develop the revised metric toolkit which includes 38 metrics that help users answer 31 key performance questions covering study start-up, conduct and close activities. Additionally, the group identifying 11 metrics as potential Key Risk Indicators to support Risk-Based Quality Management. The comprehensive metric toolkit includes an extensive overview guide and video tutorial, process maps, detailed metric definitions, and metric selection tools.

AQC Members are invited to participate in the launch meeting on April 27 at 10 am EDT to see the new metric toolkit and participate in a live Q&A session. Members can log into the AQC Knowledge Center and visit the meeting calendar to register. Contact us for information on establishing an AQC user account.

The post eCOA Process Metrics v3.0 will be released at the Metric Demo and Q&A Meeting on April 27 appeared first on Avoca, a WCG company.

AQC Members can view a recording of the meeting by logging into the AQC Knowledge Center and going to the patient diversity work group meeting archive page.

The post Patient Diversity Work Group Pauses Metric Discussions to Discuss DEPICT Legislation and the FDA’s Diversity Plan appeared first on Avoca, a WCG company.

• eCOA Process Metrics
• TMF Metrics
• Vendor/CRO Oversight Metrics
• Site Selection & Study Start-Up Metrics
• Centralized & Site Monitoring Process Metrics – Updates

Consortium members are invited to log into the AQC Knowledge Center calendar to register for meetings.

The post Metric Demo and Q&A Monthly Meeting Series appeared first on Avoca, a WCG company.

• Audit/Compliance/CAPA CoP
  • Opportunities and Challenges in the CAPA process
  • EU CTR: Practicalities for Implementing Serious Breaches
• Inspection Readiness/TMF CoP
  • Case Study and Discussion: Risk-Based TMF Document Review
  • Accurate measurement of TMF completeness
• QbD, RBQM, Quality Improvement (including centralized monitoring) CoP
  • Process Thinking When Identifying Risks and KRIs
  • RBQM and Data Management
  • MHRA Guidance and Categorizing Study Risk
  • QTLs and Companion KRIs

Meetings are open to all AQC Members, please visit the Knowledge Center calendar to register for upcoming meetings. An archive of past meeting recordings and presentations is available to Members in CoP-specific knowledge portals.

The post Community of Practice Group AQC Meetings appeared first on Avoca, a WCG company.

Consortium members are invited to join to us on February 16^th for the inaugural meeting of the AQC Patient Diversity Metric Development Work Group. During the meeting, discussion leaders will provide a summary overview of the work completed in by the Community of Practice Group in 2021 which will serve as the foundation for the new metric development work group in 2022. Specifically, we will: 

• Review & brainstorm on the attributes that are important to assess sites

• Discuss what site data is collected today

• Explore how to obtain the missing data – site survey and then an analysis tool?

Consortium members are invited to log into the AQC Knowledge Center meeting calendar to register for meetings.

The post Approaches to selecting sites capable of enrolling under-represented participants in clinical trials. appeared first on Avoca, a WCG company.

Two Metrics Development Work Groups will continue to meet in 2022 to complete the development of the Centralized & Site Monitoring Process Metrics Toolkit and the Site Selection & Start-Up Process Metrics Toolkit. A new Work Group focusing on developing Patient Diversity metrics will launch on February 16^th.

Consortium members are invited to log into the AQC Knowledge Center meeting calendar to register for meetings.

The post What new types of collaboration groups will be offered in 2022? appeared first on Avoca, a WCG company.