Which statement about sponsor responsibility is true?

Which statement about sponsor responsibility is true?

• A. The Sponsor Has No Responsibility If a CRO Is Used
• B. The Sponsor May Delegate All Duties and Still Retain Ultimate Responsibility
• C. The Sponsor Is Not Responsible for Data Integrity
• D. The Sponsor's Responsibility Is Limited to Regulatory Submissions

Answer: (B)

In this topic, the key idea is that the sponsor is ultimately accountable for the trial, even when tasks are delegated to CROs or other vendors. Delegation is allowed for operational activities, but accountability cannot be outsourced—oversight, quality management, and ensuring data integrity and participant protection stay with the sponsor. This statement is the best because it accurately reflects that the sponsor may assign responsibilities to others, yet retains ultimate responsibility for the study’s conduct, data integrity, safety reporting, and regulatory compliance. The sponsor must ensure that contracts with CROs clearly define duties, provide appropriate oversight, and verify that work performed by others meets GCP standards. The other options are not correct because they imply the sponsor’s responsibility can be completely relinquished or is limited to regulatory submissions. In reality, the sponsor remains responsible for data integrity, subject protection, protocol adherence, and overall compliance—not just for submissions to regulators.

In this topic, the key idea is that the sponsor is ultimately accountable for the trial, even when tasks are delegated to CROs or other vendors. Delegation is allowed for operational activities, but accountability cannot be outsourced—oversight, quality management, and ensuring data integrity and participant protection stay with the sponsor.

This statement is the best because it accurately reflects that the sponsor may assign responsibilities to others, yet retains ultimate responsibility for the study’s conduct, data integrity, safety reporting, and regulatory compliance. The sponsor must ensure that contracts with CROs clearly define duties, provide appropriate oversight, and verify that work performed by others meets GCP standards.

The other options are not correct because they imply the sponsor’s responsibility can be completely relinquished or is limited to regulatory submissions. In reality, the sponsor remains responsible for data integrity, subject protection, protocol adherence, and overall compliance—not just for submissions to regulators.