By signing the 1572, the investigator agrees to follow the protocol, obtain informed consent, report adverse events, and grant FDA access to records. The form lists the PI, sub-investigators, study site(s), IRB, and clinical labs.
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Glossary Term
Form FDA 1572
Clinical Operations
Also known as: 1572, Statement of Investigator, FDA 1572
The Statement of Investigator that an investigator signs to commit to conduct an IND study according to FDA regulations.
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