Developing a Quality System/Standard Operating Procedures

Medical Device Clinical Trials

Introduction

The development of quality system procedures or standard operating procedures (SOPs) for conducting clinical trials of medical devices is paramount in ensuring the trial is conducted in accordance with applicable requirements. A clear and comprehensive quality system not only safeguards participants, but also enhances the credibility of the trial outcomes. This blog outlines the components of developing robust quality system procedures for medical device clinical trials.

Framework

The framework of any quality system is based on applicable regulations, standards, and guidelines. The scope of the quality system (e.g., type of studies, geographical location) will determine what regulations, standards, and guidelines are applicable. For example, international standard ISO 13485 describes the process for establishing, implementing, and maintaining a quality system for the life cycle of medical devices while ISO 14155 addresses the standards for conducting medical device clinical studies. Although the Good Clinical Practice (GCP) guidelines were written for pharmaceutical studies, many principles are applicable to device studies. Regulatory compliance and adherence to ethical and scientific standards and guidelines are the foundation to ensure quality in clinical trials.

Components

A quality system encompasses policies, procedures, and templates to provide consistency and compliance. Key elements of a quality system may include:
• Quality Manual: This document outlines the quality policies and objectives of the organization, serving as a roadmap for the quality system.
• Procedures: Detailed, written instructions are necessary for critical clinical processes, such as trial document development, site selection, data management, and monitoring. The procedures also define key terms.
• Templates: Standardization across studies aids in project management, and also confirms that the required elements are included in trial documents.
• Training: Relevant personnel should be trained once the quality system is established and for major updates.

Content

Standard procedures are a way to demonstrate compliance by describing how regulations are met. For example, sponsors are responsible for selecting qualified monitors and ensuring proper monitoring (21 CFR 812.40). In the US FDA Bioresearch Monitoring (BIMO) program for sponsors and CROs, inspectors will review sponsor’s procedures and study documents related to monitoring. Thus, a quality system should include the process for selecting monitors and conducting monitoring.

Suggested areas to address in clinical quality procedures include:
• Site and investigator selection
• Study document development and maintenance
• Vendors and outsourced services oversight
• Risk management
• Safety oversight
• Monitoring
• Data management
• Statistical analysis
• Product accountability
• Clinical trial registration

Overcoming Challenges

The clinical aspects of the quality system should integrate with existing systems and procedures without over-burdening resources. To do this, document the current clinical processes, identify any gaps with applicable standards and regulations, and incorporate that information into the procedures. Templates, such as one for a monitoring plan, can be developed to improve efficiency. Training before implementing changes to the quality system can reduce chances for error and increase adherence to procedures.

Continuous Improvement

A quality system should include mechanisms for continuous improvement. This involves regular review of and updates to procedures to keep current with regulations and best practices. Feedback from audits and inspections should be incorporated into procedures.

Conclusion

Developing and maintaining comprehensive quality system procedures can ensure the successful conduct of medical device clinical trials and regulatory compliance.

MED offers a variety of clinical trial services and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us today to start your project discussion.

855.463.1633 | askmed@medinstitute.com | medinstitute.com.