When an investigator delegates investigational product management activities, what is required regarding oversight?

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Multiple Choice

When an investigator delegates investigational product management activities, what is required regarding oversight?

Delegation is allowed, but the investigator must maintain ongoing oversight of anyone handling the investigational product. The investigator remains responsible for the trial’s conduct, including proper product handling, storage, accountability, and documentation, and must supervise and verify that delegated personnel are qualified and trained. This oversight cannot be waived, even if risk is low, and while the sponsor may support the process, the primary responsibility for oversight lies with the investigator/institution.

Delegation is allowed, but the investigator must maintain ongoing oversight of anyone handling the investigational product. The investigator remains responsible for the trial’s conduct, including proper product handling, storage, accountability, and documentation, and must supervise and verify that delegated personnel are qualified and trained. This oversight cannot be waived, even if risk is low, and while the sponsor may support the process, the primary responsibility for oversight lies with the investigator/institution.

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