Responding to FDA Inspections in an Era of Closer Scrutiny

Glenda Guest

Understand the Process and Manage the Consequences

Many changes were made to the U.S. Food and Drug Administration’s (FDA’s) requirements for clinical research during the COVID-19 pandemic, including adoption of decentralized clinical trial (DCT) elements such as novel monitoring models, shipping investigational products to patients’ homes, and changes to document-sharing procedures. As the agency returns to a full inspection schedule, these changed models are being inspected for the first time, raising concerns at some sites about the potential for increased findings.

“DCTs will present a whole new area for FDA to dig into,” says Janet Holwell, CCRC, CCRA, TIACR, FACRP, a Clinical Research Consultant/Trainer. “This is an area where the regulations have not caught up, and to some extent, the cart got ahead of the horse. Study procedures took place away from the clinical site, sometimes carried out by third-party vendors at the participant’s home. There is a lack of clarity about the regulatory requirements in these instances, where the principal investigator has responsibility but may not have selected the vendors.”

“Key areas of concern from an inspection perspective include post-COVID changes to monitoring procedures, document sharing, and privacy issues,” notes Glenda Guest, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training. “It seems likely that errors were made despite good intentions during this challenging period. It was impossible to implement the original monitoring plans envisaged in the protocol pre-COVID, and it remains to be seen whether the necessary changes to workflows were documented adequately from a regulatory perspective.”

FDA Inspections: Understand the Process and Manage the Consequences

Join Glenda and Janet at ACRP 2023 [April 28 – May 1; Dallas, TX], where they’ll cover important Good Clinical Practice topics to prepare for audits and regulatory inspections, and other complex issues for experienced clinical researchers. View complete schedule.

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Holwell suggests that sites consider taking a proactive approach to prepare for possible inspections by always being inspection ready. When issues or non-compliance arise, put a corrective and preventive action (CAPA) plan in place. “Employing a root cause analysis – including asking the ‘five whys’ – can be carried out to ensure compliance,” Holwell notes. “Our session will explore effective methods by responding to FDA Warning Letters in a hands-on exercise. Taking a risk management approach includes avoiding gaps in resources, identifying operating guidelines to follow, and ensuring that the site has appropriate people with correct training in all roles, and with access to the principal investigator. This enables human performance to be maximized – both proactively and retrospectively.”

“Finally, if your site does have an inspection with findings, vital steps are to stay calm, notify the trial’s sponsor, and gather all stakeholders to identify the root cause and develop a CAPA plan or other suitable solution,” states Guest. “This will enable the site to respond adequately to the findings by accurately identifying and addressing mistakes to the FDA’s satisfaction.”

Written by Jill Dawson