FDA 1572 MCC Statement of the Investigation

FDA 1572 MCC Statement of the Investigation essay assignment

Review Form FDA 1572 – Statement of the Investigator, (attached). Section 9 of the 1572 outlines the commitments of the Investigator. There are a total of 8 commitments the Investigator must agree to in order to conduct a study governed by FDA regulations. Choose 1 of the 8 commitments and:

(1) Explain why it is important for the protection of the research subject.

(2) Explain what activities/responsibilities the investigator must do to meet that commitment. Reference appropriate FDA regulations to support your work. Each answer must have a minimum of 1 paragraph with at least 7 sentences per paragraph

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FDA 1572 MCC Statement of the Investigation