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
Summary
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.
- 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.