Spotlight On... Getting Your Quality Management System Right

This video provides an in-depth exploration of the critical importance of getting Quality Management Systems (QMS) right, particularly within the dynamic landscape of clinical research. Featuring Glenda Guest, VP of Norwich Clinical Research Associates and an ACRP Fellow, the discussion highlights how QMS and risk management have become paramount, especially in the era of COVID-19, which necessitated significant alterations to standard clinical trial processes. Guest, drawing from her 18 years of experience as a medical device professional, emphasizes that while QMS originated in manufacturing, its applicability to clinical research has been underscored by recent revisions to the International Council for Harmonisation (ICH) E6 guideline.

The conversation delves into how the pandemic introduced unprecedented flexibility into previously rigid rules, making robust QMS essential for maintaining quality, protecting subjects, and ensuring the integrity of data in an altered environment. Guest explains that the shift towards risk-based monitoring has placed greater responsibility on clinical sites for quality control, a challenge for many, ranging from small sites to large organizations with dedicated departments. She stresses that effective QMS links all stakeholders—sites, Institutional Review Boards (IRBs), and sponsors—and requires active engagement from regulators who now provide crucial guidance alongside traditional regulations.

A significant portion of the discussion focuses on the severe downsides of neglecting proper QMS. As an auditor, Guest frequently observes the consequences of inadequate quality, which manifest as more errors, inappropriate data collection, incorrect subject enrollment, audit observations, corrective actions, and rework, ultimately leading to potential loss of critical data. She differentiates between Quality Control (proactive measures like setting standards and training) and Quality Assurance (retrospective assessment of system effectiveness and quality attainment). The video concludes by reiterating the urgent need for sites to enhance their internal quality control mechanisms, especially as reliance on frequent on-site monitor visits has decreased, making QMS a non-negotiable necessity for safeguarding important studies, including those related to COVID-19.

Key Takeaways:

• QMS is Crucial in Dynamic Environments: The COVID-19 pandemic highlighted the indispensable role of Quality Management Systems and risk management in clinical research, as operational flexibility and altered processes necessitated robust frameworks to maintain quality and data integrity.
• ICH E6 Guideline Reinforces QMS Importance: Recent revisions to the International Council for Harmonisation (ICH) E6 guideline have brought QMS to the forefront, making it a more recognized and understood concept within the clinical research community.
• Shift to Risk-Based Monitoring Increases Site Responsibility: The move towards risk-based and remote monitoring models has significantly increased the burden on clinical sites to implement and manage their own quality control measures, a responsibility previously often shared with on-site monitors.
• QMS Encompasses Quality Control and Quality Assurance: Quality Control involves proactive steps like setting standards, training personnel, and guiding proper job performance, while Quality Assurance is the retrospective evaluation of whether the system worked and if intended quality levels were achieved, prompting necessary changes.
• Downsides of Poor QMS are Significant: Neglecting QMS can lead to a cascade of negative outcomes, including increased errors, inappropriate data collection, incorrect subject enrollment, adverse audit observations, extensive rework, and ultimately, the potential loss of critical study data.
• QMS Links All Stakeholders: Effective quality management systems are vital for connecting and coordinating efforts across all levels of clinical research, including sites, Institutional Review Boards (IRBs), sponsors, and regulators, ensuring a unified approach to quality.
• Regulators Provide Guidance in Evolving Landscapes: In times of rapid change and increased operational flexibility, regulators play an even more critical role by providing necessary guidance in addition to enforcing regulations, helping the industry navigate new challenges while maintaining standards.
• Sites Must Enhance Internal Quality Control: With less frequent on-site monitoring, clinical sites must proactively develop and implement strong internal quality control processes to prevent major losses, particularly in high-stakes studies like those for COVID-19.
• QMS Originates from Manufacturing but is Highly Applicable to Clinical Research: The concept of quality management, while originating in manufacturing, is directly transferable and highly applicable to clinical research, emphasizing process control and systematic quality assurance.
• Challenges in QMS Implementation Vary by Site Size: Both small and large clinical sites face unique challenges in implementing QMS; small sites may struggle with resources, while large sites might have established departments but still need to adapt to new monitoring paradigms.

Key Concepts:

• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
• Risk Management: The systematic process of identifying, assessing, and controlling risks that could impact the quality, safety, or integrity of clinical trials.
• ICH E6 Guideline: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R2) Good Clinical Practice (GCP) guideline provides a unified standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. Revisions have increasingly emphasized quality management and risk-based approaches.
• Risk-Based Monitoring: A strategy for monitoring clinical trials that focuses monitoring activities on the most important risks to human subjects and data quality, rather than on comprehensive, 100% source data verification.
• Quality Control (QC): Operational techniques and activities used to fulfill requirements for quality. This includes setting standards, training staff, and guiding them in the proper performance of their jobs.
• Quality Assurance (QA): A system of activities designed to ensure that quality requirements are met. It involves assessing whether the overall system worked as intended and if the desired level of quality was attained, leading to necessary changes and improvements.
• IRB (Institutional Review Board): A committee established to review and approve research involving human subjects. Its primary purpose is to ensure the ethical and scientific soundness of research and to protect the rights and welfare of human participants.
• Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.