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A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected,...

A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?

A.

The sponsor

B.

The investigator/institution

C.

The IRB/IEC

D.

The external source

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