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At what point during a clinical trial is a Form 1572 created and signed?
When should the Form FDA 1572 be completed and signed by the Principal Investigator? When a study is being conducted under an Investigational new drug application (IND). When an investigator is participating in a new protocol that has been added to the IND.
When must a 1572 be updated or a new 1572 completed and signed by an investigator to reflect new or changed information?
There are two instances where the investigator must complete and sign a new 1572: When a new protocol is added and the investigator must employ that protocol. When a new investigator is added to the investigation(21 CFR 312.53(c))
What is the 1572 rule?
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.
Can FDA Form 1572 be signed electronically?
For documents created electronically on a file system, signatures may be obtained electronically if a mechanism is available to the signer. For example, an FDA 1572 Statement of Investigator form can be filled out within Adobe and signed using an available digital certificate outside of any document management system.
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