FDA 1572 Forms: Convert or not?

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The U.S. Food and Drug Administration (FDA) provides Statement of Investigator forms—commonly known as 1572 forms— in downloadable PDF format.

The FDA's 1572 form
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.

Do I Really Need to Convert 1572 Forms to an Earlier PDF Version?

Internally, the FDA uses Acrobat 7 which can read any PDF version up to PDF 1.6. Certainly, the agency has the capability to read an Acrobat 7-level 1572 file if you submit it.

I heard from two large pharmaceutical companies which have submitted a variety of PDF 1.6 files—not just 1572’s in fact— without hearing a peep from the FDA.

To be on the safe side, however, sponsors should contact the FDA to check if they may submit files that fall outside guidelines.

If you intend to submit your IND or NDA outside the US, the picture is not so clear. In this case, you may wish to supply PDF 1.4 files.

Conversion Challenges for FDA-supplied 1572 Forms

I covered methods to convert PDF documents to earlier versions in my article Change PDF Versions for FDA Compliance.

Unfortunately, that article is not going to help you much if you try to down-convert the FDA-supplied 1572 form.

When you try:

  • Document—> Reduce File Size
  • Advanced—> PDF Optimizer
  • File—>Save As and choose Optimized PDF

You will receive this error message:

Error Message: This PDF document contains an Adobe XML form. Such files cannot be optimized.

A Brute Force Solution

One workaround is to “flatten” the forms by printing them to PDF.

Here’s how:

  • Open the 1572 form
  • Choose File—> Print
  • Select the Adobe PDF Print Driver
    Selecting the Adobe PDF print driver.
  • Click OK
  • Acrobat will prompt you for a file name
    Note: You will want to use a PDF Setting that embeds all fonts. For details on how to create that setting, see my article Acrobat Font Embedding for FDA Submissions.

Converting Many Forms

If you have Acrobat Professional, you can take advantage of the program’s Batch Processing feature to convert many 1572 forms to flattened Acrobat 5-level documents.

Batch processing can save you a lot of time!

Set-up

  1. Go to the Start menu and choose Printers and Faxes
    Printers and Faxes on the Start Menu
  2. Choose the AdobePDF driver, right-click and choose Printing Preferences
    Choose Printing Preferences
  3. The Adobe PDF Printing Preferences window opens
    Setting the default conversion setting and location for converted files.

    • Choose a PDF setting that embeds all fonts.
      Embedding Fonts: For details on how to create an "Embed All" setting, see my article Acrobat Font Embedding for FDA Submissions.

    • Click the Browse button and select an output folder to receive the “flattened” 1572 forms.
      Note: You will probably not want to use this setting for everyday PDF creation. Be sure to set it back to “Prompt for PDF File Name”.

    • Click OK

Creating a Batch Sequence

The next step is to create a Batch Sequence for conversion.

  1. Open the Batch Sequence window
    • Acrobat 8
      Choose Advanced—> Document Processing—> Batch Processing
    • Acrobat 7
      Choose Document Processing—> Batch Processing

      Creating a new batch sequence

  2. Click the New Sequence button
  3. Give the sequence a name and click OK
    Naming the Batch Sequence
  4. Click the Select Commands button
    Select commands in the Batch Sequence window
  5. Choose “Print” from the list on the left and click the Add button:
    Adding the Print command
  6. Click OK
  7. Set the output location to “Don’t Save Changes” and click OK.
    Set Output location to Don't Save Changes

Running the Batch Sequence

Once set-up is complete, running the Batch Sequence is easy.

  1. Open the Batch Sequence window
    • Acrobat 8
      Choose Advanced—> Document Processing—> Batch Processing
    • Acrobat 7
      Choose Document Processing—> Batch Processing
  2. Select the Batch Sequence you created from list and click Run Sequence
    Click the Run button
  3. Click OK in the Run Sequence confirmation window
    Sequence Confirmation window
  4. Acrobat asks you to select the files to be processed. Choose all the files needed and click the Select button.

    Select the files to process

    TIP: Hold down shift to select multiple files.

Acrobat will flatten all the forms by printing them to PDF and placing them in the output folder designated in the Set-up section above.

Final Thoughts

Flattening by “re-distilling” should only be used if you cannot use the PDF Optimizer to change PDF versions.

AcroForms—which are not XML-based—can be “flattened” using the PDF Optimizer much more elegantly.