Quality control and assurance are essential for maintaining the integrity and reliability of clinical research services. They ensure that research processes adhere to standards and regulations, minimising errors and bias in findings. We will explore best practices in quality control and assurance in clinical research, including standardised procedures, training, and technology.
Some Best Practices to Consider:
1. Operating Procedures (SOPs): Develop comprehensive SOPs that outline all processes and procedures related to data collection, participant recruitment, documentation, and reporting. SOPs should be regularly updated and followed consistently by all team members. It helps ensure that the clinical research services provided are the best and most updated.
2. Document Control: Establish a robust document control system to manage all study-related documents, including protocols, informed consent forms, case report forms, and standard operating procedures. Maintain version control, and ensure accessibility and secure storage of these documents.
3. Quality Management System (QMS): Implement a QMS encompassing quality control and assurance processes. This system should include regular audits, internal reviews, and inspections to identify deficiencies and implement corrective actions. The QMS should be robust enough to allow adding, assigning, tracking/monitoring and closing Corrective and Prevent Actions (CAPA) based on findings from routine monitoring, audits and inspections.
4. Monitoring and Auditing: Conduct regular monitoring and audit research activities to assess compliance with protocols, regulations, and ethical guidelines. Monitor participant recruitment, data collection, and adherence to SOPs. External audits can also provide an unbiased assessment of your quality control and assurance practices.
5. Continuous Improvement: Foster a culture of constant improvement by regularly reviewing processes, analysing performance metrics, and implementing corrective and preventive actions. Encourage feedback from team members and stakeholders to identify areas for improvement.
6. Compliance with Regulatory Standards: Stay updated with relevant regulatory requirements, such as Good Clinical Practice (GCP) guidelines, Local regulatory requirements, and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) recommendations. Adhere to ethical considerations, participant rights, and informed consent practices.
7. Ongoing Training: Ensure all team members and staff receive training for new procedures, SOPs, and technology. Training should include initial orientation programmes, on-the-job training, process-specific tutorials for new staff members, and refresher courses.
8. Documentation: Develop comprehensive documentation systems that ensure data quality and consistency—Standardise report formats to maintain consistency in finding summaries. Include study-specific templates and forms to ensure compliance with regulatory requirements.
9. Incorporate Quality Assurance into Routine Activities: This should go beyond the quality control and assurance processes included in study-specific activities. Design quality assurance procedures into routine clinical research activities, such as participant recruitment, consenting and enrolment, data collection, and data reporting.
10. Staff Training and Capacity Building: Expand staff capacity by providing regular training in clinical research activities. Training should include skills development, knowledge sharing, and reviewing existing processes to identify areas for improvement. In addition, staff during the clinical trials are given essential skill development training.
11. Integrating and Augmenting Quality Control to external stakeholders: All quality control and assurance processes in clinical trials/clinical research should be designed to allow the integration of external stakeholders - such as sites- and not just be limited to organisational implementation. Sites should be encouraged to develop their SOPs for conducting clinical trials, which should be reviewed for robustness during site selection. Such measures bring additional credibility to the data being generated from the sites and help gain regulatory approvals faster.
Implementing best practices in quality control and assurance is crucial for upholding the credibility of clinical research services. It promotes excellence, openness, and patient safety while making the use of research findings in clinical settings easier. Furthermore, by prioritising quality control and assurance, organisations build trust, attract collaborations, and contribute to improving healthcare services. Collaborating or using the services of clinical research organisations with well-established quality processes goes a long way in ensuring the success of clinical trials.