FDA Form 1572 Flashcards
What is FDA Form 1572?
Statement of Investigator, a document that outlines the responsibilities of the investigator in a clinical trial.
Who completes FDA Form 1572?
The principal investigator (PI) or lead researcher completes FDA Form 1572.
What information does FDA Form 1572 contain?
The form includes details about the investigator, the study site, the investigational product, and the investigator’s commitment to conducting the study in compliance with regulatory requirements.
What are the key responsibilities of the investigator outlined in FDA Form 1572?
Conduct the study according to the protocol
Ensure the rights, safety, and well-being of study subjects
Personally conduct or supervise the study
Inform subjects of changes and new information
Why is FDA Form 1572 important in clinical research?
FDA Form 1572 is important because it serves as a commitment by the investigator to comply with regulatory requirements and to conduct the clinical trial according to the approved protocol.
When is FDA Form 1572 typically submitted to the FDA?
FDA Form 1572 is submitted as part of the IND (Investigational New Drug) application to the FDA.
Can FDA Form 1572 be updated during the course of the clinical trial?
Yes, FDA Form 1572 can be updated to reflect changes in the study, such as changes in investigators or study sites.
What is the significance of the investigator’s commitment on FDA Form 1572?
PI is affirming with the FDA that they will:
-Conduct the study per protocol, without deviations, except when necessary for subject safety
-Assure only qualified staff work on the study
-Ensure informed consent is obtained and IRB reviews are met
-Maintain accurate records, available for inspection
-Obtain IRB initial approval and continuing approval
-Inform all subjects that this is an investigational drug
How does FDA Form 1572 relate to the protection of human subjects in clinical trials?
FDA Form 1572 emphasizes the investigator’s responsibility to protect the rights, safety, and well-being of study subjects, which aligns with the ethical conduct of clinical trials.
What are the potential consequences if an investigator fails to fulfill the commitments outlined in FDA Form 1572?
Failure to fulfill the commitments outlined in FDA Form 1572 can result in regulatory actions, such as study suspension, termination, or other enforcement measures.
