CITI Training Practice Exam

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What should be done when there are changes to information contained on a signed and dated 1572?

File a new 1572 immediately
Document the changes in the clinical study records
Notify the FDA directly
Publish the changes in a medical journal

The correct answer is: Document the changes in the clinical study records

When there are changes to information contained on a signed and dated 1572, the correct course of action is to document these changes in the clinical study records. This is because the 1572 is a legal contract and should be kept as a historical document. Filing a new 1572 could potentially cause confusion and does not accurately reflect the changes that have been made. Notifying the FDA directly or publishing the changes in a medical journal are not necessary as long as the changes are properly documented in the study records.