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Related Experiment Videos

TransCelerate's Clinical Quality Management System: Issue Management.

Susan Callery-D'Amico1, Leslie M Sam2, Timothy H Grey1

  • 11 R&D Quality Assurance, AbbVie Inc, North Chicago, IL, USA.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed
Summary
This summary is machine-generated.

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Effective issue management within clinical quality management (QMS) focuses on "Issues that Matter" impacting patient safety and data integrity. This approach utilizes a corrective and preventive action (CAPA) process for critical issues, enhancing risk and knowledge management.

Area of Science:

  • Clinical research quality management
  • Drug development operations

Background:

  • Issue management is a key component of the TransCelerate clinical quality management (QMS) framework.
  • Organizations need to prioritize issues impacting patient safety, data integrity, and regulatory compliance.

Purpose of the Study:

  • To define the critical elements of effective issue management in clinical development.
  • To highlight the benefits of a structured approach to issue resolution and trending.

Main Methods:

  • Triage of identified issues to determine those that are critical.
  • Implementation of an end-to-end corrective and preventive action (CAPA) process for critical issues.

Main Results:

  • Focusing on "Issues that Matter" ensures resources are directed towards critical aspects of clinical development.
Keywords:
TransCelerateclinical developmentissue managementquality management systemrisk management

Related Experiment Videos

  • A defined issue management framework enables trending and analytics for improved risk and knowledge management.

    • Conclusions:

    • A robust issue management system, incorporating CAPA, is essential for maintaining high standards in clinical research.
    • Effective issue management supports data integrity, patient safety, and regulatory compliance, while providing valuable insights for continuous improvement.