FDA 1572 Forms: Convert or not?
The U.S. Food and Drug Administration (FDA) provides Statement of Investigator forms—commonly known as 1572 forms— in downloadable PDF format.
Download the form from the FDA (Opens in a new window)
The FDA-supplied 1572 form is an XML-based form in the Acrobat 7 file format (PDF version 1.6). The date on the form indicates that it is valid through May 31, 2009.
XML-based files are convenient for data collection workflows and may be digitally signed using SAFE signatures.
However, for IND and NDA submissions, the FDA seems to insist on receiving Acrobat 5 (PDF 1.4) level files.
On the surface, it does seem that this is an example of the agency not following its own guidelines.
What should you do?
- Submit the forms in the same format supplied by the FDA?
- Convert the files to PDF 1.4?
In this article, I’ll discuss what I’m hearing from the various Pharma firms I work with and also suggest ways to convert these forms to Acrobat 5-level files.