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When is it necessary for an investigator to complete and sign a new 1572?

  1. Annually

  2. At the end of the study

  3. When participating in a new protocol added to the IND

  4. When the study concludes

The correct answer is: When participating in a new protocol added to the IND

The 1572 is a form used by clinical investigators to indicate their agreement to follow certain procedures and regulations while conducting a clinical study. It is necessary for an investigator to complete and sign a new 1572 when participating in a new protocol added to the investigational new drug (IND) application. This is because the new protocol may have different procedures and regulations that the investigator needs to agree to. The other options, such as annually, at the end of the study, or when the study concludes, would not be accurate as they do not specifically address when a new protocol is added to the study. It is important for the investigator to review and sign a new 1572 in order to ensure that they are aware of and complying with all necessary procedures and regulations for the new protocol.