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Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct...

Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?

A.

The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.

B.

The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.

C.

The CRC is responsible for identifying the relationship of an SAE to the IP.

D.

The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.

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