Back to: FDA Clinical Investigator Training Course (CITC) 2024
Presenter
Cheryl Grandinetti, PharmD
Associate Director for Clinical Policy
Division of Clinical Compliance Evaluation (DCCE)
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch (GCAB) of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators. She serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.
Abstract
Cheryl Grandinetti presents on achieving fit-for-purpose clinical trial quality, emphasizing its importance for clinical and sponsor investigators. She explains that the FDA views quality as the generation of sufficient information to support good decision-making, which means avoiding “errors that matter” to participant safety or trial credibility. This approach is founded on quality by design (QbD), proactively integrating quality from the trial’s outset, and risk proportionality, which involves directing efforts towards the trial’s critical aspects. Grandinetti highlights that initiating the QbD process during the design phase is crucial, as the protocol serves as the blueprint for quality. Key elements include identifying critical to quality factors—attributes fundamental to participant protection and reliable results—and understanding potential risks to these factors. She discusses how international guidelines like ICH E8(R1) and the draft ICH E6(R3) support these principles, allowing for flexible application tailored to specific study needs and risks. A case example demonstrates how neglecting these principles, such as failing to plan for e-diary issues, can compromise data reliability. The presentation concludes by stressing that quality by design is essential for managing trial conduct proportionately, focusing resources on high-risk areas and critical data points to ensure participant safety and reliable study results.