New FDA Protocol Deviation Guidance: Planning for the Things That Don’t . . . The guidance provides advice, as well as specific examples, to assist in defining Important Protocol Deviations and highlights the roles and responsibilities of sponsors, investigators, and IRBs in monitoring, mitigating, and reporting protocol deviations
Protocol Deviations Explained: Understanding the FDA’s Draft Guidance Protocol deviations, whether unintentional or planned, can significantly impact the quality and credibility of clinical investigations By aligning with FDA’s draft guidance, sponsors and investigators can better safeguard participant welfare and ensure data reliability
Navigating FDA Feedback on Clinical Protocols: Key Considerations Handling FDA feedback on original clinical protocols is a pivotal aspect of advancing a new therapy, with significant implications for your investigational new drug (IND) application and overall program direction
Conducting Research Accurately: A Guide to Protocol Deviations The Food and Drug Administration (FDA) and other regulatory entities rely on accurate reporting of protocol deviations to assess the reliability and validity of research data, as well as to confirm that subject rights, safety, and well-being are protected
FDA protocol deviation guidance could go further There has been some guidance in documents by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), however, there has been no guidance until now from regulatory agencies as to how they view protocol deviations
Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in . . . As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in clinical investigations (“Draft Guidance”)
How To Design A Clinical Trial Protocol With Patient And FDA Collaboration The wide-ranging discussion produced several key takeaways, including direct insights into how these seasoned drug developers have approached protocol design, collaboration with patient advocacy groups, and FDA relationship-building