As a response to the COVID-19 Pandemic, the US Food and Drug Administration has recently issued a new guidance document for industry, investigators and institutional review boards titled “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic”. This guidance recognizes that the COVID-19 pandemic brings new challenges in the ability to follow clinical trial directives and can lead to difficulties in meeting required procedural and protocol requirements, such as the inability to conduct mandated site visits, or disruption in access to investigational products.
To address this, the FDA’s new guidance document outlines additional considerations to assist sponsors in continuing their trials in a compliant manner during this time. This guidance does not decrease the FDA’s expectations or relax any regulations, but rather emphasizes the requirements for sponsors to have established policies and procedures in place that detail and justify the measures taken to react to obstacles encountered or deviations caused by the pandemic. It also emphasizes approaches required to be taken for studies to proceed and outlines the requirement of thorough documentation to record events and to have established continuity procedures in place for all trials potentially impacted by the pandemic.
These actions may come in the form of clinical study report narratives that outline the contingency measures implemented to respond to any disruption caused by the COVID-19 outbreak, listing of impacted subjects and/or sites, overall analysis of the impact to the study, as well as any protocol modifications or deviations that are necessary to minimize the impact of trial integrity.
Amidst all these considerations for executing clinical studies during a time of uncertainty, ensuring and demonstrating the compliance and quality aspects of your company’s clinical quality management system and ongoing clinical trials remains a regulatory requirement. If you’re unsure how your compliance policies and procedures measure up, our complimentary GCP Auditing Checklist can help.
In the face of new challenges, having Good Clinical Practices in place can lessen the impact these obstacles have on the integrity and overall success of your clinical trials. If you find yourself struggling to keep up with the FDA’s new guidance, ProPharma Group is here to assist.
Our Clinical Quality consultants have extensive auditing, technical writing, and operational experience to support your organization’s clinical quality needs. Additionally, our wide array of regulatory and compliance services includes vendor qualification audits, mock regulatory inspections, gap analyses, quality management system development and optimization, and interim quality management. Contact us to discuss how we can help keep your clinical trials moving forward in light of COVID-19.
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