Audits and clinical trials

Audits and clinical trials


The current focus in the clinical research world is moving into technological transformation. The changes associated with this transformation have the impact on many aspects of clinical trial management, such as risk management, remote monitoring, electronic Trial Master File, electronic patient related documents, electronic patient informed consent, use of EDC software, validation of systems and other e-tools and systems used to ensure proper compliance on the regulatory/sponsor´s requirements and adequate clinical trial oversight.


It is not new that the audits have still an important role in quality management of clinical trials. However, the conducting of the audits needs to reflect the technological transformation as well.



It is well known that the people have tendency to stick what they have done in the past and the auditors are not different. Also, nowadays auditing needs to reflect more and follow technological progress in the clinical research world. It means the audit planning, conducting and follow-up should be modified to use the available technologies to make the audit more effective and faster in comparison to old fashion “paper on-site” way of auditing. There are already possibilities to conduct the audit remotely or in a combination of remote and on-site audit depending on the technological maturity of the auditee. For sure, there are still some on-site audits which have their important and unique role. However, the modern technologies bring also new aspects and possibilities to the on-site audit. It is clear the remote access to documents, databases or listings from the systems provides the auditor with a lot of information and brings more advantages for the audit itself. In addition, the role of communication (regardless if done remotely or in person) between the auditor and auditee is key factor for the audit success.


Thus, what the auditor needs to fulfil to follow changing clinical research world?


The auditor needs to have good understanding of IT technologies, databases, validation of software´s to efficiently use technologies prior, during and after the audit. The auditor must not be afraid of using modern technologies, should see their potential advantages and would use them as an effective tool and source of information. Nowadays the speed of IT development is extremely fast and cannot be compared with the time Good Clinical Practice became effective in 1997. It is extremely difficult for auditors who started their careers 20 years ago, to understand every new development and new process the modern world makes possible. However not understanding must not mean automatically a finding for an auditor.

As the audits become more remotely or in a combination of remote and on-site audits on one hand and the IT knowledge gap between auditee and auditor might be available, the communication skills of the auditor play key role in successful audit. The auditor should listen to the auditee and should be experienced enough in all ways of communication to the auditee to build-up a trustful relationship. Especially in remote auditing the communication is the most important factor. Without trust the auditee will not be willing to disclose the information to the auditor. If the integrity of data, processes and systems are doubtable, because of lacking communication, the number of audit observations will not reflect the real quality at the audited site or system. Such audits are useless, and the auditee lose the chance to improve the system. Trust between auditor and auditee should help to find out the real cause of issues and set up the lessons learned on all levels. The old-fashioned auditing model when the audit was performed on paper-based documents with limited time on-site and authoritarian way of communication between the auditor and auditees belongs to the past.

Hereinafter, the clinical trials are going to become more international which brings the additional responsibility of expertise on the auditor´s shoulder. The auditor needs to become familiar enough with local regulatory requirements or better become a part of the international network of auditors to ensure the proper regulatory expertise on national level. However even though the knowledge in local regulatory requirements can be learned via training, the cultural differences between the auditees all over the world cannot be overcome by simple training.


Therefore, the role of the auditor is rapidly changing as the whole clinical research world. Nowadays the auditor needs to become expert in the modern technologies’ areas, but also have good communication skills and should be willing to adapt according to cultural differences. The similar trend is visible in regulatory authorities´ inspection approach when the team of regulatory experts with high-level expertise are coming for the inspections.



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