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The following information is intended to provide sponsor-investigators with information to guide them through the FDA requirements for sponsor-investigators who hold an IND. The federal regulations for INDs are found under 21 CFR 312. Responsibilities of sponsors and investigators are also contained in the International Conference on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice. For more information, review the FDA’s Center for Drug Evaluation and Research (CDER) web site www.fda.gov/cder.
This text is a synopsis of requirements specific to sponsor-investigators who hold INDs. It is intended to be a guide, but does not include the complete text of the regulations. Hyperlinks for the corresponding regulations are included throughout the section. Sponsor-investigators must review and be familiar with the federal regulations before undertaking these responsibilities.
Sponsor-investigators are also required to follow all federal regulations and University of Iowa policies and guidance for Human Subjects research, and VAHCS requirements as applicable.
When an Investigator holds an IND for the product being tested in a particular research study, he/she must also assume the role of the Sponsor, and is called a “Sponsor-Investigator.” The FDA defines a Sponsor-Investigator as “means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.” [21 CFR 312.3]