Knowing the difference between quality control, a method of continuous monitoring; and quality assurance, a system of critical review, helps people to understand the role of clinical auditors in the United States.
Why Do Clinical Auditors Exist
Clinical auditors perform quality assurance, while monitors perform quality control, a routine monitoring at the study site. The role of clinical auditors exists in clinical research because medical and regulatory professionals recognize the potential harm to patients.
That is why the professionals want to make sure that patient care is free from risk and pain. They mean that clinical research should be safe and effective for every participant. Therefore, people with concerns about these things produce clinical auditors and their functions in clinical research.
The Meaning of Clinical Audit and Clinical Auditors
Lokuarachchi defines the word clinical audit as: “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.”
In other words, clinical audit is quality assurance. Then, the term clinical auditor could mean: “a person who seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change.”
The Functions of Clinical Auditors
Clinical auditors make sure that regulations and guidelines throughout the clinical development process, from the design of the protocol to the final clinical study report, are correct. They review and assess site activities, ensuring that contractual obligations to client companies are met.
They also make sure that clinical studies are conducted in compliance with protocol requirements, federal regulations, International Conference for Harmonization (ICH), Good Clinical Practices guidelines (GCP), and Standard Operating Procedures (SOP). As a result, they ensure that the rights and welfare of research subjects are to be protected at all times.
They ensure that the data submitted to the Food and Drug Administration (FDA) in support of New Drug or Device Applications is supported by source documents. They also ensure that monitoring activities are conducted within the regulations and guidelines established by the FDA and ICH.
Before Clinical Auditors Visit a Study Site
To keep FDA regulations, SOP, and GCP guidelines in check, clinical auditors must plan correctly before performing an audit. To do it correctly, they plan an audit according to special needs of each site. That means the audit can be all-inclusive for each study. They plan the audit this way so that they can make sure that what should be done is being done correctly at the site.
Before executing any plan that they have, clinical auditors prepare themselves and the site by contacting the site. Then, they call the site staff to set an appointment suitable for both parties before they mail the confirmation letter to the site. They do it this way to avoid confusion during auditing.
Clinical Auditors Follow These Procedures
Clinical auditors are required to function in a specific way in auditing a study. Lokuarachchi describes five stages of the auditor's role. Clinical auditors:
- identify the problem to be audited.
- set the criteria and standards for the audit.
- collect the data and observe the practice of the trial site.
- compare the practice of the site with the standards.
- implement changes.
After comparing the practice with the standards, clinical auditors usually write a report of audit results.
When the Audit Ends
In their report, clinical auditors include all audit responses that have to be made and finalized within the SOP time frame. After they have finished the audit report, clinical auditors prepare the exit meeting, at which they present their findings.
During the exit meeting, the Principal Investigators and Clinical Research Coordinators must be present, while the clinical auditors are presenting the findings and explaining why each finding is of concern. Clinical auditors also suggest some steps for improvement to the site.
The job of clinical auditors involves quality assurance. Quality assurance verifies and controls quality control, which is done by continuous monitoring. When people know that quality assurance encompasses quality control, they most likely understand how clinical auditors fulfill their role.
Reference:
Lokuarachchi, Sandhya K. 2006. “Clinical Audit – What is it and How to Do It?” Galle Medical Journal. Sljol.info accessed April 19, 2010.
