What must an investigator agree to when signing Form FDA 1572?

What must an investigator agree to when signing Form FDA 1572?

• A. To only use approved drugs
• B. To conduct the study according to the protocol and FDA regulations
• C. To report results only in the journal
• D. To limit participation to a specific demographic

Answer: (B)

When an investigator signs Form FDA 1572, they are formally agreeing to conduct the clinical study in accordance with the study protocol and all applicable FDA regulations. This commitment ensures that the investigator understands their responsibilities, which include adhering to the protocol's design and methodologies, maintaining participant safety, and following Good Clinical Practice (GCP) guidelines. Signing this form is critical for regulatory compliance, as it holds the investigator accountable for the integrity of the study and ensures that the research is conducted ethically and scientifically. The agreement to adhere to the protocol and FDA guidelines helps to secure the credibility of the study results and protects the welfare of the participants involved. This choice emphasizes the fundamental obligations of the investigator related to proper conduct and oversight of the clinical trial, ensuring that the research meets both legal and ethical standards in clinical research.

When an investigator signs Form FDA 1572, they are formally agreeing to conduct the clinical study in accordance with the study protocol and all applicable FDA regulations. This commitment ensures that the investigator understands their responsibilities, which include adhering to the protocol's design and methodologies, maintaining participant safety, and following Good Clinical Practice (GCP) guidelines.

Signing this form is critical for regulatory compliance, as it holds the investigator accountable for the integrity of the study and ensures that the research is conducted ethically and scientifically. The agreement to adhere to the protocol and FDA guidelines helps to secure the credibility of the study results and protects the welfare of the participants involved.

This choice emphasizes the fundamental obligations of the investigator related to proper conduct and oversight of the clinical trial, ensuring that the research meets both legal and ethical standards in clinical research.