Which factors influence the level of investigator oversight when activities are delegated?

• A. Investigator's personal experience alone.
• B. Time of day the product is administered.
• C. Factors include the characteristics of the investigational product, route and complexity of administration, and the level of existing knowledge about the product's safety and marketing status.
• D. Number of sites involved.

Answer: (C)

In Good Clinical Practice, supervising delegated activities is guided by a risk-based approach. The level of investigator oversight should align with the potential risk the task poses, which is largely determined by three key factors: the characteristics of the investigational product, how the product is administered (route and complexity), and what is already known about the product’s safety and regulatory status. If the product is novel or has unknown safety signals, or if its administration is complex or risky (for example, requiring special handling, monitoring for infusion reactions, or strict aseptic technique), closer supervision is needed. Conversely, if the product has an established safety profile, is given by a simple route (like oral dosing), and there is substantial existing knowledge from prior data or marketing experience, less intensive oversight may be appropriate. Time of day and the number of sites involved don’t determine the depth of supervision in the same way, and relying solely on the investigator’s personal experience doesn’t establish a risk-based framework for delegation.