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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. However, it is NOT required for post-marketing and observational studies. Form
1572 asks, among other things, for the Investigator to indicate the
IRB that is responsible for review and approval of a research project involving
investigational drugs. The Form also asks for the names of all the sub-investigators
who will be assisting the [Principal] Investigator in the project including
research fellows, residents and associates, anyone who makes a direct and
significant contribution to the study data, has significant trial related
duties, and who is involved in treatment and/or evaluation of research subjects. |