Deep Lens Blog On the Importance of Self-Audits in Clinical Research

Quality Improvement is essential to ensure that the rights and wellbeing of patients participating in clinical research are protected. The goal of an audit is to review whether clinical research is being conducted in compliance with applicable federal regulations and to help ensure the quality of data submitted with a new drug application (NDA). Of the site investigations completed by the FDA over the last 5 years, nearly 20% identified a failure to follow the investigational plan. Another 10% identified inadequate and inaccurate records. Proactively conducting self-audits helps prepare your research department for an external review and helps to improve the research processes for optimum quality. FDA requires clinical investigators to provide access for reviewers to inspect case histories of research subjects and other records such as informed consent forms, documentation of the consent process, reported data, and regulatory records source documents. FDA may conduct both announced and unannounced audits. Additionally, for-cause audits may be conducted in cases of possible noncompliance, data discrepancies, or concerns over the ethical conduct of the study by the investigator. For-cause audits could be initiated if the study sponsor reports concerns on study conduct to the FDA and could also be conducted by the IRB and sponsor.