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How should the 1572 be completed?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Form 1572 may be completed on FDA’s website and printing the completed form. It is also acceptable to print the form from the FDA website and hand-write or type the information onto the form. The FDA prefers the typed form because it adds to the legibility of the document. Lastly, the completed form must be signed and dated by the investigator (both hand-written or electronic method is acceptable).

 

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