The 1572 has two purposes:
- 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,
- 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.
