Drug development consists of a series of steps aimed at the commercialization of a safe and effective product for humans.
From "bench" (laboratory counter) to bedside, each phase is finely monitored and controlled by regulations dealing with drug production and clinical trials.
For the commercialization of a new medicine, the experimental drug must be tested on human subjects. Once the necessary data are collected, they are used to request market access by the pharmaceutical company (or as it is commonly called, the Sponsor), after having proven the safety and effectiveness of the drug.
All the phases that characterize the testing of a drug on humans fall under the term “clinical research”.
As anticipated, the trial takes place according to specific regulations and guidelines. These include EU Regulation 536/2014 and Good Clinical Practice (ICH-GCP R2).
The current legislation also highlights the necessity of performing examinations on the study by the Sponsor. These checks are defined as Audits.
GCP audits aim to verify that the trial is conducted according to the study protocol, the Standard Operating Procedures (SOPs), as well as the current regulations on clinical trials.
Generally, audits are performed on-site at the experimental centers where the clinical trial is conducted.
Auditors are responsible for carrying out independent audits. This means that they cannot hold operational roles during the conduct and management of a study, and must be as foreign as possible to the study to ensure that they are not affected by the processes or by the professionals involved during the verification activities.
In order to carry out audits, the auditor needs to carefully analyze the documentation of a clinical trial, such as:
the study protocol;
CVs and training certificates of the staff of the center involved in the study;
the monitoring plan and laboratory manuals;
the scheme of the EDC and eCRFs;
any other documentation required by the study.
Each audit shall be announced; This means that, prior to the audit date, the auditor sends an agenda containing the details of the audit, the processes to be checked and the related personnel tha should be present.
Following the analysis of the documents foreseen during the preparatory phase, the auditor conducts the audit at the center by visiting the facilities involved in the study (laboratory, pharmacy, hospital ward rooms), and performs interviews with random and designated staff elements. In addition, the auditor reviews the study documentation stored in the Investigator’s Site File (ISF), ensuring that it is complete and consistent.
At the end of the audit, the auditor communicates to the center the main observations that emerged during the audit, and then draws up an audit report containing a detailed description of what was viewed and examined and the eventual deviations found. These findings shall be based on precise regulatory references and classified according to an appropriate grading.
For each audit performed at the center, the auditor is required (according to regulations) to issue a certificate attesting that the audit has been carried out.
The complex audit activity thus recalls the two key principles of clinical research, namely the protection of patients' health and the integrity of the experimental data collected.
To learn more about the role of the GCP auditor, you can view the course in italian "La ricerca clinica e il ruolo dell'Auditor GCP" on the e-learning platform by clicking the button below:
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GCP system audits;
Study audits at experimental centers;
Supplier qualification audits.
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