1572 Flashcards
Why does the 1572 form need to be completed by an investigator?
A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial. The investigator verifies that he or she has the experience and background needed to conduct the trial and that it will be done in a way that is ethical and scientifically sound.
What are the 1572 two purposes:
1) to provide the sponsor with information about the investigator’s qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation
2) to inform the investigator of his/her obligations and obtain the investigator’s commitment to follow pertinent FDA regulations. Investigators should complete the form as accurately as they can. Investigators should be aware that making a willfully false statement is a criminal offense under 18 U.S.C. 1001. Further, submission of a deliberately false statement to the sponsor or to the agency can be taken into consideration in a disqualification proceeding.
