Get AK Sample Form 1572 2007-2023

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

However, the 1572 does not need to be edited and a new one is not required. The sponsor can collect certain information and implement them to the IND. Examples of such information are an amendment or protocol amendment.

In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person should be listed on the Form FDA 1572.

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.

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.

When a new investigator is added to the study (21 CFR 312.53(c)). It must be completed and signed before an investigator can participate in a clinical investigation. in section #9 of the Form FDA 1572.

Under FDA regulations, a 1572 is only required for studies of investigational drugs and biologics conducted under an IND. It is not required for studies that are not done under an IND and is not applicable to investigational device studies.

FDA Form 1572 is the statement by the investigator that he/she will abide by the federal regulations set forth in the Code of Federal Regulations for the use of drugs in an investigational setting. Any study operating under an IND requires submission of FDA Form 1572 to the sponser.