WEBINAR · September 14, 2023, 07:00 AM PDT | 10:00 AM EST | 16:00 CET | 19:30 IST
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Session Overview: In this educational webinar we will move beyond the theory and purpose of QTLs and examine commonly applied QTL approaches in clinical trials. We will highlight the pros and cons of different approaches and outline key considerations to support your organization and project teams efficiently implement meaningful QTLs on their trials.
Overview
Applying QTLs on a trial can be difficult and applying them in a meaningful and efficient way even more so. ICH-E6 R2 Guidelines recommend QTLs be established as a risk control to identify systemic issues that can impact subject safety or reliability of trial results. To set them up effectively requires careful thought on what parameters to monitor as well as how to set appropriate QTL thresholds. With competing study start-up activities and limited QTL expertise in many organizations, it is no wonder why QTLs are often implemented that do not meet the intended objective.
Participants will leave with a better understanding of common QTL approaches, key considerations for implementing meaningful QTLs on their study, as well as things to consider if they are looking to build a library of re-usable QTLs within their organization.
What You'll Learn
- Understand the pros and cons of commonly applied QTL approaches in clinical trials.
- Key considerations to build a small library of re-usable QTLs within an organization.
- Key Questions to ask when determining & developing QTLs for a study.
- How to lead Data Quality Meetings.
Who Should Attend
The audience would be intermediate (CCDM) and advanced (CCDS).
Meet the Speakers
Sr. Director, Product
ThoughtSphere
As Senior Director of Product at ThoughtSphere, Christina translates vision into strategic objectives to support the product roadmap to accelerate and modernize clinical trial operations. Christina is a strong proponent of innovation and actively seeks opportunities to apply novel technology and data science to create efficiencies and draw insights from operational and clinical trial data. She has authored thought leadership whitepapers and articles to share information and support the expansion of data science in clinical operational processes.
ThoughtSphere
Prior to joining ThoughtSphere, Christina worked in the CRO industry for over 16 years, holding leadership roles in Data Management, Clinical Data Science, Central Monitoring, and DCT Operations. In addition to leading a team of Central Data Scientists, she served as a Subject Matter Expert for RBM/RBQM, centralized monitoring, and digital health solutions in several company initiatives.
Director, Data Management
ICON PLC
Regionally
based in Victoria, British Columbia, Canada, Lynn has over twenty two years of
clinical research experience, including 11 years in
the evolving space of Risk Based Monitoring and Data Science. In her current
role, Director, Data Management, Lynn is
responsible client oversight as well as onboarding and overseeing regionally
based Clinical Data Scientists Leads who assess trial compliance by
participating in upfront risk assessment and performing trend analysis,
exploratory data reviews and reporting risk associated with the data to
internal and external stakeholders. Lynn has been instrumental in developing and evolving the
global Central Monitoring activities and serves on many cross-functional
initiatives to drive process and technology enhancements.
ICON PLC
Stephen Cameron
Director, Clinical Data Management
ICON PLC
Twenty-five years of biotechnology, microbiology and clinical trial data management. Areas of focus include recombinant, subunit, attenuated and whole cell bacterin and viral vaccines, cellular therapy, oncology, gout and biosimilar studies as well as monoclonal therapies. Significant exposure to global team leadership, project management and data operations functional management support for local and global team members, including clinical data coordinators, lead data managers and functional managers. Active member of Society of Clinical Data Management, chairing and speaking on sessions on decentralized clinical trials, audit trail review, the evolution of CDS and leadership forums. Working as conference co-chair for 2020 through 2023 for the annual conference and elected board of trustees member 2022 through 2024.
ICON PLC
Twenty-five years of biotechnology, microbiology and clinical trial data management. Areas of focus include recombinant, subunit, attenuated and whole cell bacterin and viral vaccines, cellular therapy, oncology, gout and biosimilar studies as well as monoclonal therapies. Significant exposure to global team leadership, project management and data operations functional management support for local and global team members, including clinical data coordinators, lead data managers and functional managers. Active member of Society of Clinical Data Management, chairing and speaking on sessions on decentralized clinical trials, audit trail review, the evolution of CDS and leadership forums. Working as conference co-chair for 2020 through 2023 for the annual conference and elected board of trustees member 2022 through 2024.
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
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