Remarque Systems

Quality Management in Clinical Trials, Part 1: Stick to the Plan

Quality management plans have been implemented in clinical trials for a while now. However, recent initiatives like the ICH GCP E6 (R2) addendum have truly emphasized the importance of adopting a quality management approach to monitoring risk and ensuring trial success. Regardless of where they are operating, sponsors and CROs need to have a comprehensive strategy to not only meet these requirements, but to minimize risk and maximize the ROI of their trials.

While most companies today understand the importance of meeting objectives like protecting patients, fulfilling compliance requirements, and minimizing risk in relation to quality improvement, they tend to encounter obstacles when it comes to actually taking steps to achieve these objectives. In this new blog series, we’ll look at what it takes to make quality management a priority in your clinical trial – starting with what’s required for a Clinical Trial Quality Management Plan (QMP).

What Is a Clinical Quality Management Plan?

Under ICH Good Clinical Practice, quality assurance refers to any action that is intended to ensure clinical trials are performed in compliance with Good Clinical Practice and any relevant regulatory requirements. Quality assurance also refers to any actions that ensure that data are generated, recorded, and documented in compliance with these standards. Quality assurance systems consists of multiple operational activities and techniques, which are intended to confirm that the standards for the quality of activities related to a clinical trial are being met.

Clinical trials typically have thorough monitoring plans. Regular monitoring makes it easy to confirm the compliance of a clinical trial with Good Clinical Practice and any relevant protocol and other regulatory guidelines. Therefore, it is recommended that a monitoring plan is designed and put into effect for every clinical trial. The thoroughness of the monitoring should be based on a number of factors, such as trial design, size, complexity, and the objectives.

Components of a Clinical Trial QMP

There are two key tools that are used for quality checks: Source Data and Essential Documents. Source data refers to the information in records of clinical observations, findings, and other activities that are needed for the evaluation and reconstruction of the trial. Records for source data are referred to as source documents.

The verification of source documents is an essential aspect of a clinical quality management plan. The verification of source data involves making sure the data variables accurately correspond to the information within the source documents. The extent of this verification is based on factors like phase of the study, complexity of the clinical trial, the number of subjects enrolled, and the risks for subjects. Researchers can select any option that is suitable for the clinical trial.

Essential documents allow the evaluation of the quality of the data collected from a trial as well as an evaluation of the actual conduct of the clinical trial. These documents are produced to show compliance with regulatory requirements and the Good Clinical Practice standards. It is recommended that these documents are filed as soon as possible to make clinical quality management easier.

Quality Management Is a Continuous Process

Historically, these standards were made in the context of the manufacturing environment. However, according to regulatory bodies like the FDA, innovation and continual improvement will be facilitated by implementing ICH Q10 throughout the lifecycle of a product. This implies that the standards that have been applicable to the manufacturing environment should also be relevant during the clinical research process.

Today, technology can help to streamline the time and cost requirements of a QMP. In the clinical research field, a quality management system (QMS) refers to any system that is designed to make these principles applicable to clinical study start up and clinical monitoring. Although, not all quality management systems are created equal, as we’ll discuss in a later post.

Implementing a clinical quality management plan is a step that all organizations, that conduct clinical studies, need to take to ensure the safety and quality of their products. However, a focus on quality should start even earlier. Stay tuned for the next post in our series for a look at how Quality by Design (QbD) can enhance your clinical trial. To learn how the Remarque QMS helps manage quality starting at the patient level, check out our video demo.