TransCelerate’s Clinical Quality Management System: Issue Management

Abstract

Issue management is one of the elements of the TransCelerate clinical quality management (QMS) conceptual framework. Effective issue management benefits clinical development organizations by allowing them to focus efforts on those issues that materially impact patient safety, rights, and well-being; data integrity and/or scientific rigor; compliance with regulatory requirements; or trust in the clinical research enterprise, which have been defined as “Issues that Matter.” Issue management begins with a triage of issues to identify those issues that materially impact as defined above, which are then handled by an end-to-end corrective and preventive action (CAPA) process. An added benefit of a well-defined issue management framework is the capability for trending and analytics designed to provide data and insights into risk management and knowledge management efforts.