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Which of the following is an adequate definition of quality assurance for the conduct of...

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Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?

A.

The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects

B.

The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements

C.

An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial

D.

The act of reviewing and approving the investigational protocol and informed consent document

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