Expert Recommendations for FDA eCopy Submission

Expert Recommendations for FDA eCopy Submission

April 10th, 2013 // 10:35 pm @

April 10, 2013


Our April 10 Webinar on Avoiding the eCopy Confusion by Antoinette Azevedo had some vital expert recommendations. For instance Print to PDF is NOT an option with preparing PDFs for eSubmitter! This webinar really helped to shed some light on this very confusing and misunderstood guidance that became a requirement on Jan. 1. Some of Antoinette’s other recommendations and comments on eCopy and eSubmitter included the following:

  • The eCopy guidance suggests that you can submit either a volume or a non-volume structure for your submission with eSubmitter. A volume-based submission is recommended for the largest and most complex submissions, such as submissions with folders with one or more PDFs. However, Azevedo stated that the best thing to do is to assume the worst case scenario and to just use the volume-based approach. She thinks that due to the complexities and vagaries of the system, going with the most structured approach is going to lead to the fewest problems with your FDA reviewer.
  • Azevedo stated that a non-volume submission will have the eCopy restriction of one PDF file not being more than 50 MB. This is not practical due to the requirements for supporting documents, so again, a volume based approach is desirable for all submissions.
  • When you are setting up your file folders (VOL_002, VOL_003 etc), you should add corresponding tabs with each volume. For example – VOL_004 Tab 3 Certification of Compliance with ClinicalTrials_gov Data Bank. This will help your reviewer be able to correspond each volume to the proper section in the paper portion of the submission if any.
  • You also should add a Tab number to your file names to provide help for your reviewer.
  • All security restrictions must be removed from your PDF file submissions. She recommended that you use A PDF Restriction Remover. She has not received a response from FDA on whether this is an acceptable program, however.
  • To create your PDFs for the eCopy submission, you really need to know how to use Adobe Acrobat. Print to PDF is NOT an acceptable way to create PDFs. Printing to PDF will not include bookmarks or hyperlinks, which the reviewer has to have. You need to remediate your PDFs for them to be usable in eCopy.
  • Adobe Acrobat XI Professional is the best version to use for eCopy and eSubmitter.
  • Hyperlinks and bookmarks should be used as they help your reviewer. You cannot hyperlink to other PDFs – only inside one PDF. Bookmarks should be used for the main table of contents of the submission and for sections, subsections and captions of figures and titles.
  • FDA’s free eSubmitter program is the best option for assembling your eCopy submission. If you do not use it, you really have to know how to conduct PDF remediation, and you will need to be very strict in your naming requirements. You also have to have much expertise with MS Word for PDF conversion.
  • eSubmitter has many challenges, however. There is very limited technical support – by email only. FDA does not answer questions quickly, and sometimes they give contradictory answers.
  • Due to the complexities of eCopy and eSubmitter, a strong relationship with your FDA project manager is vital. You should talk to him or her on the telephone often and provide as much information as possible in your submission. The more you communicate with the reviewer, the smoother your eCopy process will be.

We are repeating our live eCopy Webinar on May 2 – please check it out.

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