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EMA COVID-19 Guidance and Auditing activities

With the outbreak of the COVID-19 virus the European Medicines Agency (EMA) issued guidance on 20th March 2020 for conducting Clinical Trials during the Pandemic. While the guidance was primarily focused on the study designs to minimise the impacts on patient safety, data efficacy and reducing the burden on medical staff who are focused on supporting our healthcare systems; it provided a framework for how audits could be more dynamic in ensuring adequate oversight during the pandemic.

With access to countries and investigator sites severely restricted, auditing and monitoring activities have also been significantly impacted, sponsors are looking at ways to continue to have oversight over the study compliance at investigator sites in order to be able to accurately assess the ongoing risks to subject safety and well-being and overall study integrity. Zigzag Associates has significant experience with conducting a variety of remote audit types to support Clinical Research programs and sponsor compliance and in light of the current pandemic crisis, has developed two new audit types “Study Compliance Audits” and “Remote Investigator Site Audits”, to provide sponsors with an independent assessment of their oversight over the study and its management.

The Study Compliance Audits are designed to assess the compliance of the clinical trial with the scope of services, contractual obligations, study requirements, local and global regulatory requirements, Standard Operating Procedure (SOP) compliance and the inspection readiness of the study. The audit can be adapted based on the stage of the study to allow sponsors to focus reviews on higher risk study activities.

Remote Investigator Site Audits are providing sponsors with an independent Quality Assurance (QA) review and cross comparison of data captured in multiple electronic systems and supported within the sponsor’s documentation present in the electronic Trial Master File (eTMF). This is a detailed assessment including a wide system review of all the data which is associated with a site which remote monitoring activities may not cover.

With the introduction of these new audits, we believe it will assist sponsors to identify new quality key risk indicators, assist in prioritising monitoring activities (remote and on-site) and permit the sponsor to continue to meet their regulatory obligations during the COVID-19 pandemic crisis. We also believe it will help the sponsor to assess the effectiveness of their risk mitigation steps after the crisis has passed.

The above article was prepared by Paul MacMahon, Senior QA Manager.

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