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A monitor is conducting a site closeout visit.

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A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?

A.

A copy of the final report for the IRB and investigational product shipment records

B.

Informed consent documents and printouts of electronic source documents

C.

Printouts of electronic source documents and the remaining investigational product

D.

Informed consent documents and investigational product documentation

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