Which monitoring strategy is mentioned as being an option under ICH E6?

The correct choice highlights that ICH E6 recognizes a combination of on-site and centralized monitoring as a valid strategy. This approach allows for a flexible and comprehensive assessment of clinical trial conduct by integrating both traditional, in-person inspections and modern remote monitoring techniques.

The rationale behind this combination is to enhance the efficiency and effectiveness of monitoring efforts, maximizing the quality and integrity of trial data. Combining these methods allows for more thorough oversight of trial activities, using technology to support and supplement on-site evaluations. By leveraging centralized monitoring techniques, sponsors can identify issues proactively and ensure compliance without the need for constant, in-person visits.

The other choices do not encompass the flexible approach encouraged by ICH E6. Relying solely on in-person or remote monitoring limits the effectiveness and responsiveness of the oversight. Exclusively conducting annual audits also falls short, as it does not provide ongoing monitoring throughout the trial, which is essential for ensuring data integrity and participant safety.