FDA Issues New Guidance Document on Clinical Trial Investigator Responsibilities
Written by: Jacqueline BarrowsTuesday, November 10th, 2009 | FDA Medical Device Regulations
FDA has issued final guidance on “Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects.” The guidance document is now available from FDA’s website at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf
The clinical trial investigator responsibilities within the FDA regulations are specific but, at the same time, limited in depth. This guidance document expands FDA regulations by specifying more clearly the agency’s intent. For example, the guidance expands the scope of a principal investigator’s (PI) responsibility to oversee the clinical trial, including training staff, selecting appropriate staff when delegating tasks, ensuring control over third -party team members, and maintaining written records to document the delegation activities.
This new FDA guidance document clarifies the PI’s role and raises the importance of PI oversight to a more visible level. The guidance addresses a real need to add substance to the PI’s responsibility in FDA regulated clinical trials.
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