Quality Management in Clinical Research and the Value of Audits Rita Hattemer-Apostel Verdandi AG, Zürich (Schweiz) Regulatory authorities expect quality assurance programs being established at sponsors and external service providers; however, this should not be the only reason for implementing a proper QA program. QA audits can help ensure the integrity and validity of clinical trial data from the beginning to the end, from trial planning until the final study report through auditing. Audits assess if studies are conducted in an ethical manner, if the trial participants’ safety and well-being is respected, if the clinical data is valid and the trials are accurately reported.
The following article sets out to provide a profound basis on quality management aspects in clinical research. It looks at the origins of quality management and auditing and explains key definitions related to quality management in clinical research, quality control (QC) and quality assurance (QA) as well as why QC and QA must be clearly distinguished. Possible follow-up activities, such as corrections, corrective and preventive actions, are also defined and how they relate to QC and QA is described. Effective quality management systems are composed of different components which are presented in the article. However, the focus of quality management systems in clinical research extends not only to compliance, documentation and transparency but also to ethics − a dimension to be particularly aware of in GCP QA.
Audit types (e.g. trial-specific and systems audits), audit locations and the time point of audits (e.g. prospective, ‘in-life’ and retrospective audits) are presented in detail as these variables are determined by the purpose and the aim of an audit. The article discusses the value of audits and also addresses the possible downside of auditing. Apart from confirming compliance or uncovering compliance deficiencies, audits provide the basis for continual improvement in that they highlight areas for improvement and, due to the auditors’ independence from operational functions, help overcome the ‘blind spots’. Audits prevent quality management systems from getting rusty and auditees (and auditors!) from getting complacent, and they ensure the continued ‘fitness’ of the company to meet internal and external requirements. |
