Lack of adequate oversight and improper delegation of authority continue to dog clinical trial operations. One or both of those problems are frequently cited by U.S. Food and Drug Administration (FDA) investigators in Form FDA 483s (“Inspectional Observations”) after inspection of a study facility, notes Mariette Marsh, MPA, CIP, director of the Human Subjects Protection & Privacy Program for the University of Arizona. “It’s a consistent problem,” she says.
Typical red flags for FDA? “A lack of solid standard operating procedures” and an inability to handle changes and other updates to the trial protocol, Marsh says.
According to the FDA, the buck stops with the principal investigators (PIs); however, Marsh says it’s getting tougher and tougher for PIs to provide direct oversight for personnel working complex trials. That means it’s imperative for PIs to learn how—and when—to delegate.
It’s critical to implement a system to document delegation of authority in a regulatory-compliant manner. However, that documentation must be based on a clear understanding of the investigator’s responsibility for study conduct. “You need to know how to obtain and maintain ethically responsible delegation of authority,” Marsh says.
Webinar: How to Ensure Study Compliance and Integrity through Training and Delegation of Authority – Join Marsh and colleague Wendy Tate July 11 to gain an understanding of the regulatory requirements of investigator oversight and tips for ensuring investigators are properly engaged with delegated duties, that study staff entrusted with study conduct are properly training, and that delegation of authority documentation is maintained. View Program Details
There’s no one-size-fits all approach here. However, Marsh outlines a few areas that can be appropriate for a PI to delegate to proper staff:
- Regulatory paperwork/monitoring of completion requirements
- Data entry
- Sponsor communications not relating to subject safety
- Clinical trial finances
- Changes to the protocol not affecting study design and/or risk
However, there are any number of areas a PI should rarely, if ever, delegate. Some of those include:
- Changes to the protocol affecting study design and/or risk
- Review of severity of adverse events
- Appropriateness to include potential participants in alignment of protocol inclusion/exclusion criteria
The FDA is clear about its expectations for PIs. In addition to being able to demonstrate qualifications and address any potential conflict of interest, FDA demands that PIs receive appropriate training and perform supervision over third parties involved in the trial.
Given today’s trial complexity, it’s not an easy balancing act for PIs or anyone else on the trial team.
Author: Michael Causey