Welcome to the next entry in our glossary series! In this series, we are reviewing key definitions found in the Good Clinical Practice (GCP) guidelines used by regulatory agencies, like FDA, for achieving high quality and consistent clinical trial operations that adhere to the ethical tenets of human research protection.
Auditing is defined by the guideline as, “A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).”
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Contrast that with the guideline’s definition of monitoring: “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).
Although both auditing and monitoring address the consistency, quality, and compliance of a clinical study, they do so differently.
Monitoring includes scrutiny of the data collected and procedures followed to ensure the consistency, accuracy, and quality of the study. It is an ongoing process during the execution of the trial. You can learn more about monitoring from previous blog posts by clicking here and here.
Auditing evaluates the processes and systems in place at the sponsor, site, contract research organization (CRO), or data management (DM) level from a bird’s eye view rather than from an ant’s view. It evaluates whether those systems are adequate to support an organization and its staff in conducting a clinical trial in accordance with the protocol, SOPs, and the appropriate regulatory requirements. This is not to say that individual patients or data fields are not scrutinized as in monitoring, but that the intention of auditing is to analyze the capacity of the systems in place for conducting a high quality study with integrity–one in which study subjects are treated within the ethical constructs that the international community has adopted.
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Often a sponsor will audit investigational sites and important study vendors (CRO or DM companies) in anticipation of an FDA audit, but some sponsors will conduct these audits on a periodic basis, often annually, for a longer-term study. Sponsor audits may be conducted for cause as well, if a problem is suspected.
Audits support monitoring, and vice versa, in identifying potential problems as early as possible in a clinical study. As we’ve discussed before, the earlier a potential problem can be uncovered, the faster it can be resolved, leading to fewer surprises down the road.
Thanks for tuning in to Hart Clinical Consultants’ glossary series!
Next time, we will look at the GCP glossary terms for blinding or masking of studies.