ICH E6 Practice Exam 2025 – Complete Prep Resource

When sponsors delegate responsibilities to a contract research organization (CRO), it is essential to maintain oversight of the delegated duties. This oversight is fundamental for ensuring that the CRO operates in compliance with regulatory requirements, upholds the integrity of the study, and meets the sponsor's quality standards. The sponsor retains ultimate responsibility for the conduct of the study, so they must ensure that the CRO operates within the parameters set by the sponsor, follows the study protocol, and adheres to applicable laws and regulations.

Having oversight means that the sponsor actively manages the relationship with the CRO, including regular communication, monitoring performance, and auditing as necessary. This ensures that any issues can be identified and addressed promptly, contributing to the overall success of the clinical trial and safeguarding participant safety.

The incorrect options highlight practices that do not align with best practices in clinical research. Complete transfer of obligations without oversight undermines the sponsor's accountability, while minimal communication would hinder effective collaboration and responsiveness to issues. Allowing the CRO to operate independently without guidelines could lead to non-compliance and variability in the trial conduct, which poses significant risks to the study's validity and its outcomes.