Question

When signing the FDA Form 1572, the investigator confirms that he/she has read the investigator's brochure. True or False?

Answer 1

When signing the FDA Form 1572, the investigator confirms that he/she has read the investigator's brochure.

Step-by-step explanation:

When signing the FDA Form 1572, the investigator confirms that he/she has read the investigator's brochure. This is true. The investigator's brochure is an important document that provides detailed information about the investigational product being studied. By confirming that they have read the brochure, the investigator ensures they have a comprehensive understanding of the product's characteristics, risks, and benefits.

Answer 2

True. When signing the FDA Form 1572, the investigator confirms that he/she has read the investigator's brochure.

Step-by-step explanation:

The FDA Form 1572, also known as the Statement of Investigator, is a document used in clinical trials. When an investigator signs this form, they are confirming their commitment to conducting the trial in compliance with regulatory requirements. This includes confirming that they have read the investigator's brochure, which provides essential information about the investigational product, including its properties, risks, and potential benefits. By signing the FDA Form 1572, the investigator acknowledges their understanding of the study drug and their responsibility to conduct the trial according to the protocol, Good Clinical Practice (GCP), and applicable regulatory guidelines.

Option True is the answer.