What is the role of the investigator if delegation occurs?

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Multiple Choice

What is the role of the investigator if delegation occurs?

Even when tasks are delegated to others at the trial site, the investigator retains responsibility for the study and must maintain appropriate oversight. The investigator ensures that delegated duties are carried out in accordance with the protocol, GCP, and regulatory requirements, and that staff are qualified, trained, and supervised. Documentation, such as a delegation log, should specify who is responsible for each task and the level of supervision. The sponsor may provide monitoring and support, but oversight at the site is not transferred away from the investigator. The IRB approves the protocol and consent process, not every delegated task, and it does not assume day-to-day supervision of staff. Delegated tasks require ongoing supervision to protect subject safety and data integrity.

Even when tasks are delegated to others at the trial site, the investigator retains responsibility for the study and must maintain appropriate oversight. The investigator ensures that delegated duties are carried out in accordance with the protocol, GCP, and regulatory requirements, and that staff are qualified, trained, and supervised. Documentation, such as a delegation log, should specify who is responsible for each task and the level of supervision. The sponsor may provide monitoring and support, but oversight at the site is not transferred away from the investigator. The IRB approves the protocol and consent process, not every delegated task, and it does not assume day-to-day supervision of staff. Delegated tasks require ongoing supervision to protect subject safety and data integrity.

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