FDA 1572 Form: The FDA 1572 Form is completed and signed by the Investigator of Record (IoR). An IoR is defined as the physician responsible for ensuring that a clinical investigation is conducted according to the obligations stated in the signed FDA 1572 Form. 

The National Cancer Institute (NCI) requires annual filing of the FDA 1572 Form as assurance to Cancer Therapy Evaluation Program (CTEP) that all NCI-sponsored trials carried out under the investigator will be performed following ethically and scientifically sound principals. 

A new FDA 1572 Form must be submitted to the Program Management Board (PMB) whenever a change in any of the required information, such as the name or address of the IoR or a change in the site IRB, occurs within the current year.

The FDA Form 1572 

An investigator that is involved in drug or biologic research under Investigative New Drug (IND) regulations is obligated to sign a FDA form 1572. The PI signs a contract with the FDA which documents his or her agreement to follow the protocol and study obligations and alleges their knowledge and skill in conducting the trial. The investigator makes this contractual commitment when the FDA form 1572 (drug/biologic studies) or Investigator's Agreement (device studies) is signed; the PI serves as the communication link between the sponsor and the FDA. A change in the PI or sub-I requires approval by the HAC and the sponsor. An amendment to the 1572 or Investigator's Agreement must be submitted to the HAC within thirty days of the change. Both the sponsor and the HAC should receive a copy of the amended 1572 or Investigator's Agreement. 

A criminal offense is committed if any information has been falsified or if associated commitments (listed on the 1572) are disregarded. 

FDA Form 1572 Contains:

Name, address of Principle Investigator (PI) 
Protocol name 
Signature of PI 
Investigator's CV 
Name of sponsor 
List of sub-investigator(s) name(s) 
Name, address of site 
Name, address of IRB 
Name, address of lab 
Statement of investigator's commitment to: 
Conduct investigation with the protocol, FDA regulations and IRB conditions 
Make changes in investigation only with appropriate sponsor and IRB approval except where immediate intervention is required to protect subjects 
Ensure informed consent requirements met for all subjects including those used as controls 
Report adverse events 
Keep current records 
Personally conduct and/or supervise investigation 
Read and understand investigator's brochure 
Ensure that an IRB reviews and approves the study initially and on a continuing basis