How Sponsors And Sites Work Together To Improve Protocol Compliance

By Kate Yawman, Director, Product Management

In the execution of clinical trials, collaboration between sponsor study team members and research sites is crucial. This partnership is vital to mitigate quality concerns and prevent FDA warning letters. During FDA site inspections, potential violations are identified and categorized as observations or findings. Deviations, findings, and failures occur when the study conduct and processes deviate from the planned course.

Findings represent significant deviations necessitating a corrective and preventative action plan. Inspection failures occur when broader concerns arise that could jeopardize regulatory approval. The FDA has reported a 36% failure rate in clinical trial site inspections. Common causes of findings include failure to adhere to the investigational plan and inadequate or inaccurate record-keeping.

To enhance quality and efficiency, sponsors, CROs, and site teams should provide visit guidance and calculators, offer continuous trial training, and centralize access to essential resources and documents. These strategies aim to reduce protocol deviations and enhance compliance and quality. By implementing such measures, clinical trial teams can streamline operations and minimize the risk of regulatory issues.