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Archive: Establishing Quality Tolerance Limits

Course #: BI14018
August 13, 2020

Course Description

ICH GCP E6 R2 Section 5.0 has given the clinical research industry the guidance to incorporate and customize all facets of risk management in clinical trials. Section 5.0.4, Risk Control, asks that predefined quality tolerance limits (QTLs) be established considering the medical and statistical variables that can impact subject safety or the reliability of trial results through the identification of systematic issues. Once detected, those issues can be evaluated and acted upon. In this web seminar, participants will learn the methodology for establishing, evaluating, and maintaining appropriate QTLs as they relate to clinical research trials.

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Learning Objectives

  • Define QTLs and understand their purpose
  • Evaluate the requirements that propel the development of QTLs
  • Examine the protocol to identify critical processes that may impact subject protection and/or data integrity
  • Document the development process
  • Implement established QTLs
  • Track and assess data to establish whether they are within QTLs
  • Respond when the QTLs are exceeded
  • Recognize evolution of QTLs over the life of a clinical trial
  • Modify QTLs depending on circumstances
  • Document to justify any changes to QTLs

Who Should Attend

  • Managers/Directors: Clinical Operations, Quality Management, Compliance
  • Clinical Quality Assurance Professionals


Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.