Measuring lung function as a primary or secondary outcome in a clinical trial can be problematic secondary to factors that affect variability other than a physiologic response in the subject. In lung function testing variability can be subdivided into three major categories; the subject, the testing environment including the device, and the testing personnel. The Clinical and Laboratory Standards Institute, an internationally recognized organization that writes standards and guidelines for laboratory medicine published a guideline that integrated the International Organization for Standardization (ISO) quality systems model into a laboratory/healthcare practice model several years ago. We will define the model and its application in spirometry testing and how integration of the quality system model into your lung function protocol can help reduce variability.

Webinar Objectives

  • Describe the Clinical Laboratory Standards Institute’s Quality System Model
  • Define the path of workflow and the points of variability/error that occur at each stage in spirometry testing
  • Understand mechanisms to reduce variability in lung function testing

Speakers

Carl D. Mottram, RRT, RPFT, FAARC, Director, Mayo Clinic Pulmonary Function Laboratories and Pulmonary Rehabilitation Program

Carl D. Mottram, RRT, RPFT, FAARC, is the Director of the Mayo Clinic Pulmonary Function Laboratories and Pulmonary Rehabilitation Program and holds the academic rank of Associate Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, USA. He is a graduate of the Mayo Clinic’s Respiratory Therapist program and currently serves as adjunct professor for the Mayo Clinic/University of Minnesota program. He is also the former Chairholder of the American Association for Respiratory Care’s Clinical Practice Guideline Committee. Mr. Mottram has served in numerous roles with CLSI, including a member of various working groups, Vice-Chairholder of the Area Committee for Health Care Services, and currently serves as the Chairholder of the Consensus Committee for Quality Systems and Laboratory Practices. He is a member of the Board of Trustees for the National Board for Respiratory Care. He also serves as a consultant to the Diagnostic Accreditation Program of British Columbia. Mr. Mottram is a recognized expert in the field of pulmonary diagnostics and is the author and editor of the definitive textbook in the field. He has published numerous abstracts, articles, and book chapters, and has given hundreds of lectures at national and international meetings.

Who Should Attend?

This webinar will benefit medical and non-medical professionals in the biopharmaceutical industry, especially those supporting Asthma, COPD and other Respiratory drug development with roles in:

  • Clinical Research
  • Clinical Development
  • Medical Affairs
  • Clinical Operations
  • Project Management
  • Data Management

Xtalks Partners

Vitalograph 

Vitalograph is specialist core lab that provides standardized equipment and centralized services for cardio-respiratory clinical trials. With a 50 year heritage as a leading cardio-respiratory device manufacturer, Vitalograph delivers high levels of flexibility and a speed of response that larger, non-specialised companies struggle to match.

Our clinical trials offering includes project management, centralized data management, over-reading and a global 24/7 support service. We also have a dedicated integrated solution via our Spirotrac® Centralized Spirometry System that includes site based 12 lead ECG, Holter monitoring, FeNO measurements, 6MWT, pulse oximetry, challenge testing, 12-lead ECG, AIM inhaler trainer and the In2itive™ e-Diary that complies with FDA‘s PRO guidance with validated questionnaires. All data is accessible via our VIEWER™ web portal.

Vitalograph’s high performance products are designed to meet or exceed medical device standards and can be customized to fit your study parameters to ensure consistent delivery of high quality data, on time and on budget.

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