Good Clinical Practice (GCP) site audits are not conducted for all clinical studies, yet they are a key quality assurance function, providing a valuable comprehensive overview of a clinical study – not only to determine if the objectives of International Conference on Harmonization (ICH) GCP are being met and the required standards adhered to, but also to determine if the monitoring function is optimal which ultimately all goes back to a holistic perspective as to whether the objectives of GCP are being met.
The difference between monitoring and auditing
There is a distinct separation between the definitions and purpose of monitoring and auditing. The purpose of monitoring is to verify that the rights and well-being of human subjects are protected; the reported trial data is accurate, complete and verifiable according to the currently approved protocol/ amendments, and the trial is conducted in compliance with the applicable regulatory requirements. required standards. Conversely, an audit is independent of and separate from routine monitoring or quality assurance functions. (ICH GCP E6 (R2)).
The purpose of an audit
The main purpose of a GCP site audit is to determine if the objectives of ICH GCP are being met. The auditor evaluates study conduct and data recording against other required standards including but not limited to the study protocol, GCP, local and international guidelines, regulations and applicable legislation, as well as site Standard Operating Procedures (SOPs). Hence an audit is conducted to determine whether the rights, safety and well-being of research participants are protected and if the data is accurate and credible to be accepted for inclusion in the submission dossier for registration of the new investigational product.
The comprehensive and universal nature of the audit ensures that it includes compliance of the site monitors. Site monitors have various challenges with regard to the monitoring function including; on-site time restrictions, the volume of and varied nature of the information requiring review and verification. Furthermore a monitor’s verification may be restricted to specific data points and details at the monitoring visit – as described in the Monitoring Plan. Subsequently the monitor’s view of the study may not be as inclusive as an auditor’s would be.
When should audits be conducted?
Sponsors often request an audit towards the end of a clinical study. This is not the ideal time for a compliance audit as it may be too late to restore any study non-compliance, which can have the effect of negating a key benefit to the study.
A timeous GCP site audit would be when the site and the study are able to benefit from the audit observations in order to improve compliance for the study so that the rights, safety and well-being of research participants are protected and the quality of the data can be improved, in the event it is not optimal. The site and clinical study should both extract maximum benefit from the independent review.
Preparation for audits
Preparation for an audit should be minimal as a researcher’s responsibility is to always abide by the required standards and act with the right intention when conducting clinical research. Quality assurance functions which include site monitoring and site GCP audits play an extremely important role to determine compliance and ensure any identified non-compliance is restored on a continuous basis. It is however important that the review is independent and universal and this is where GCP site audits are invaluable. Audits are the golden thread in clinical research conduct – not only to ensure that research conduct is ethical but also to ensure research with integrity!
References:
- International Conference on Harmonization (ICH). 2016. Guidance for industry. E6 good clinical practice: intergraded addendum to ICH GCP E6 (R1) – consensus guideline. 59 p.