Whenever a sponsor selects a new investigator to participate in a clinical investigation that is being conducted under an investigational new drug application (IND), the sponsor must obtain a completed and signed 1572 before permitting the investigator to begin participation in the clinical investigation (21 CFR 312.53(c)). The investigator should sign the form only after being given enough information to be informed about the clinical investigation and to understand the commitments described in Section #9 of the 1572. Having enough information about the study typically means that the investigator has received copies of, has read, and understands the protocol and investigator’s brochure (if required 2), and is familiar with the regulations governing the conduct of clinical studies. The investigator’s signature on this form constitutes the investigator’s affirmation that he or she is qualified to conduct the clinical investigation and constitutes the investigator’s written commitment to abide by FDA regulations in the conduct of the clinical investigation.
