Quality assurance is a critical element of a clinical trial, as it ensures the safety of the participants, as well as the reliability and integrity of the documentation and data, and therefore the validity of your results. But what does it entail, when should it happen, and how can you get it right? We share our insights.
In order to ensure the results of your clinical trial are valid and compliant, it is important to undertake quality assurance. Quality assurance (QA) is a set of processes through which you can systematically ensure your trial meets certain standards, such as ethical or data integrity standards and Good Clinical Practice (GCP).
QA is an integral part of the infrastructure of clinical research at every step. During planning and protocol writing, QA might involve checking the methodology and ensuring ethical standards are met. During regulatory submission, QA ensures all documentation is complete and correct. Throughout the clinical trial, QA ensures ongoing ethical and legal compliance, adherence to protocols and standard operating procedures. And QA plays an important role in data management throughout the process, from collection and entry to publication.
But why does it matter? In short, QA helps make sure the research is compliant with applicable regulations, the participants are safe, and the results are reliable. It can make a real difference to your clinical trial in several ways, including by helping you:
- Ensure participant safety through risk assessment and mitigation
- Meet ethical standards by following best practices
- Produce valid results by improving data integrity
- Remain compliant with applicable national and international regulations, standards and guidelines
- Avoid issues that can lead to delay by mitigating risks and identifying problems early
The link between QA and Good Clinical Practice (GCP)
One feature of QA is ensuring compliance with GCP – and GCP includes reference to QA. The GCP guideline ICH E6 defines QA as: “All of those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and applicable regulatory requirement(s).” This reflects the role QA has in good clinical practice, as well as the importance of assuring the quality of and adherence to GCP. This is also highlighted in the EU Clinical Trials Regulation, which came into force in January 2023. The Regulation defines GCP as “a set of detailed ethical and scientific quality requirements for designing, conducting,
performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust.”
According to the Regulation, the clinical trial’s sponsor and investigator are responsible for making sure that “the clinical trial is conducted in accordance with the protocol and with the principles of good clinical practice” – and QA has an important role to play in doing this.
How can you implement QA in your trial?
Specific approaches to QA will look different depending on the type of intervention on trial, the study design, and the phase, size and location of the trial. Here are some actions you can take to implement QA in your trial.
Develop standard operating procedures – these can give you a framework to follow for everything from enrollment to reporting. With this in place, QA can help you compare how the trial runs to how it was planned and identify any discrepancies.
Control documentation – ensure you have a system for control of documentation set up from the very start, so from the moment you begin working on your study design, protocol and submission dossier, you can be assured of reliability and comprehensiveness that keeps the trial compliant. Sponsors and investigators are legally required under the EU Regulation to keep a clinical trial master file. Digital technology – for example, an eTMF such as eTMF Connect from Montrium – can help control documentation, including who has access to it.
Train everyone involved – making sure investigators, support staff and anyone else working on the trial are trained in the protocol and standard operating procedures, as well as GCP and their individual roles, is part of QA.
Integrate quality into data management – a big part of QA is checking the validity and reliability of your data. You can boost this by ensuring all data management and statistics team members are working together to collect high-quality data, and by using approaches to improve accuracy, such as double data entry and data validation checks.
Embrace technology – traditional QA often involves audits carried out at trial sites. These take a risk-based approach and usually only identify problems that have already occurred. There have been developments in data-driven approaches, often enabled by AI and machine learning, to help highlight issues before they occur.
What you need for QA
The requirements for successful QA will depend on your specific clinical trial, but there are a few aspects that support QA in general. Because it spans the timeline and all functions involved in a clinical trial, QA requires good coordination. This might involve having communication channels between teams or across countries, establishing a position of QA control or working with a third party to coordinate QA work across the trial. Similarly, an independent view can help when it comes to monitoring and auditing the trial – a third party can highlight any quality issues without vested interest and suggest actions for improvement.
Do you need support for your clinical trial quality assurance? Siron Clinical can help – we offer QA services including clinical study document review, accompanied site visits and inspection preparation site visits. Find out more.