FREQUENTLY Asked Questions
When and why does the Form FDA 1572 need to be completed by an investigator?
View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Form FDA 1572 serves two main purposes:

  1. The first is to provide the sponsor with the investigator’s qualifications and information about the clinical site. In summary, the first purpose is to inform the sponsor that the investigator is qualified, and the clinical site is an appropriate location for clinical investigation.
  2. The second purpose is to inform and clarify the obligations of the investigator and to acquire investigator’s commitment to follow pertinent FDA regulations. Investigators must complete the form as accurately as they can and must understand that willfully false statement is a criminal offense. Submission of deliberately false statement to sponsor or the agency can lead to disqualification.

When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation. The investigator should sign the form after receiving enough information about the clinical investigation and commitments described in Section #9 of the 1572. The investigator must receive, study, and understand investigation protocols, investigator's brochure (if required), and must be familiar with regulations governing the conduct of the clinical studies.

The investigator's signature on the form confirms his or her qualification and commitment to conduct the clinical investigation according to the FDA regulations.

Related FAQs:
More Questions? We're here to help!