Every clinical research company along with its employees undergoes different inspections and audits before, during and after the start of clinical trials. The objectives and purposes of these procedures include enhancing patients’ safety, the ways of treatment, plus increasing the standard of care. Therefore, check-ups of this kind are equally important for healthcare, for the industry, for clinical trial participants and for research organisations as well.
How has the term “audit” evolved over time?
Despite the current significance and major role of audits, at first they were really slow to catch on what was happening in the field. Because of the constant flow of changes, auditors had to progressively change their scope of actions and focus too. Along with this, the definition of audits also experienced some alterations so the word itself acquired various meanings across the years.
Back in 1989, people referred to such practices as “medical audits”. During the same years, the White Paper, “Working for patients” (an authoritative report), defined it as
“the systematic critical analysis of the quality of medical care including the procedures used for diagnosis and treatment, the use of resources and the resulting outcome and quality of life for the patient.”
Later on, medical audits grew into clinical audits, so their meaning and what they encompassed were revised. The NHS Executive explained that;
“clinical audit is the systematic analysis of the quality of healthcare, including the procedures used for diagnosis, treatment and care, the use of resources and the resulting outcome and quality of life for the patient.”
But the transformation of the term does not end here. The paper “Principles for Best Practice in Clinical Audit”, published by the National Institute for Health and Clinical Excellence (NICE), gives yet another definition of clinical audit, which is:
“a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery.”
In brief, audits offer methods for systematically-performed periodical reviewing practices. They examine whether data recording, data reporting, execution and analysis of the trial are all in line with GCPs and in accordance with the trial proposal, regulations and other applicable regulatory requirements.
What makes clinical audits important?
There are tons of reasons which mark audits as essential and important. For example, some of the benefits of auditing include:
- finding and promoting good practice
- improving the quality of services and outcomes delivered to users
- delivering useful information which indicates the service as effective enough
- gives numerous opportunities for education and training
- promising better use of resources which boosts trials’ effectiveness
- enhancing professional practices, working relationships, collaboration and communication between agencies, personnel, as well as staff and service users
What areas can be audited?
The subjects which are suitable for audits are many and they vary. And because of the huge range of applicable areas, experts take advantage of the so called Donabedian model which narrows down the choice of topics. It presents a framework for evaluating the quality health services and healthcare. The Donabedian model outlines three main cornerstones:
- Structure: it comprises of factors such as equipment, physical facility, organisation of resources, training of personnel and payment methods;
- Process: it includes actions like diagnosis, treatment, preventive care, patient education and actions taken by trial volunteers or their families;
- Outcome: it is the sum of all effects of healthcare on human subjects, like changes which occur in health status, behavior, knowledge and others;
Other areas subjects to audits are: regulatory documentation, clinical documentation, CRF and source documentation consistency, randomization and others.
In conclusion, clinical audits are fundamental when we talk about clinical control. Their natural cycle of actions and practices include choosing a topic, preferably one which comes with highest priority levels, selecting criteria, measuring level of performance against standards, responding to findings to achieve improvements and, lastly, maintaining those improvements. Keeping all of this in mind, it is crucial to CROs that any member of staff is well trained and has sufficient experience on the subject matter. In this regard, Astra Nova offers well-organized training which will provide employees with the necessary pack of knowledge and skills.
To review our Preparing for Regulatory Audits course visit the link bellow.