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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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