Avoca, a WCG company

AQC Patient Diversity Work Group Members Reviewing Key Site Attributes to Include in Site Assessment Scoring Tool

AQC Patient Diversity Metric Development Work Group members met on 9 June 2022 to discuss the challenges organizations encounter developing patient diversity plans, identifying sites able to recruit under-represented patient populations (URPP) and tracking recruitment success. They reviewed how current AQC tools and the new proposed site assessment tool will help organizations address some of […]

AQC QbD-RBQM-Quality Improvement CoP Group Exploring Current QTL Practices and Use of KRIs

The WCG MCC QTL working group – a multistakeholder group of industry experts – met on 10 occasions over a 5-month period in 2021 to discuss challenges and best practice approaches for implementation of Quality Tolerance Limits (QTLs). The work culminated in a three-part article in Applied Clinical Trials. MCC founder Linda Sullivan and QTL […]

Is it possible to measure TMF completeness accurately? It may be worse than you think!

AQC’s Inspection Readiness | TMF Community of Practice Group Will Explore the Topic during June 14th meeting 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 […]

QTL Working Group Publishes 3-part Series

In late 2020, WCG MCC members decided to develop guidance on quality tolerance limits (QTLs) – regarding metrics, implementation and use – by channeling experiences from across the industry. A working group of 20 individuals (representing 16 organizations) met virtually during 2021 to discuss the challenges and develop a leading practice approach to be shared […]

eCOA Process Metrics v3.0 will be released at the Metric Demo and Q&A Meeting on April 27

The MCC eCOA Process Metrics Work Group (now part of WCG AQC) – comprised of more than 200 individuals representing over 40 organizations – worked collaboratively from September 2020 to December 2021 to develop the assets contained in the eCOA Process Metrics Toolkit v3.0. The decision to review and update the eCOA metric toolkit was […]

Patient Diversity Work Group Pauses Metric Discussions to Discuss DEPICT Legislation and the FDA’s Diversity Plan

The AQC Patient Diversity Metric Development Work Group was scheduled to discuss member feedback about the draft site diversity assessment scoring tool at a meeting on April 14. However, the agenda quickly changed when the FDA released a new draft guidance entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups […]

Metric Demo and Q&A Monthly Meeting Series

Throughout 2022, the AQC will host a monthly meeting for Members to learn about metric toolkits available in the AQC Knowledge Center. During the 1-hour virtual meeting, metric experts will provide an overview of a selected toolkit, show how to use the toolkit metric selection tools, and answer audience questions. The metric toolkits scheduled for […]

Community of Practice Group AQC Meetings

The highly rated Community of Practice (CoP) groups meet as part of the AQC member program, sharing ideas and practical approaches to address challenges unique to each community. Members determine priority topics and share knowledge through case study presentations, panel sessions, and facilitated brainstorming sessions. The following three CoPs will meet in 2022 and discuss […]

Approaches to selecting sites capable of enrolling under-represented participants in clinical trials.

These topics were explored in the Patient Diversity Community of Practice Group virtual meetings on August 12 and September 9, 2021. The group developed a draft list of attributes and brainstormed about how to measure / assess site capabilities. The site attribute list was shared in a joint meeting with the Site Selection and Start-Up Process Metric Development […]

What new types of collaboration groups will be offered in 2022?

During 2022, AQC will offer members the opportunity to participate in two new types of collaboration groups: Communities of Practice (CoP) and Metric Development Work Groups (MDWG). Members can participate in CoP groups that cover four areas: Compliance/CAPA, Innovation Adoption (including AI/ML), Inspection Readiness/TMF, and QbD-RBQM-Quality Improvement (including centralized monitoring). Each Community of Practice – […]

Ask the Experts: ICH E6 R2 Requirements

Q: ICH E6 R2 requires us to focus particularly on critical data and processes in quality risk management. Do you have any metrics that help assess whether our efforts are focused in this way? (Metric Insights Aug. 2021) A: This was a topic of discussion in the Centralized & Site Monitoring Process Metrics Work Group meetings earlier […]

Ask the Experts: Vendor Oversight

Q: One of our vendor oversight metrics measures whether our CRO has billed us for the amount that we expect by quarter. We are finding that this sometimes green even though we know there are problems with costs not matching the work that should have been completed. Or it might be red but when we drill […]

Ask the Experts: Risk-Based Monitoring

Q: Since we implemented Risk-Based Monitoring we have been trying to monitor the process to determine how well it is working. We have developed metrics such as whether alerts from Centralized Monitoring are closed on time but are uncertain what to use as a target. How are other organizations approaching this? (Metric Insights, Jan. 2021) A: With […]

Ask the Experts: KRI Thresholds

Q: We are accelerating implementation of our Centralized Monitoring program due to the COVID-19 pandemic. We’ve started with a small number of Key Risk Indicators (KRIs) including AEs/patient. We have upper and lower threshold limits, so we can look for outlier sites – those that are over- or under-reporting relative to others. But what we’ve […]

Category: Metrics