Can a 1572 be electronically signed?
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.Click to see full answer. In this…
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.Click to see full answer. In this way, does FDA accept electronic signatures?The FDA cannot hold digital signatures to a higher standard than paper signatures. The FDA will not check the signature on an electronic or paper-based submission unless there is a directed inspection involving that submission.Also, who needs to be on a 1572? As commonly used, the term is meant to indicate that each co-investigator is fully responsible for fulfilling all of the obligations of an investigator as identified in 21 CFR 312.60. Thus under 21 CFR 312.3(b), each co- investigator is an investigator, and as such must sign a separate Form FDA 1572. In this manner, who signs FDA form 1572? The 1572 itself does not need to be revised and a new 1572 need not be completed and signed by the investigator. The sponsor can accumulate certain changes and submit this information to the IND in, for example, an information amendment or a protocol amendment.What is the 1572 form?The Statement of Investigator (Form FDA 1572) is a form that is required to be filled for clinical trials involving investigational drugs or biologics.
