At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened). We’re often asked if there is a specific reason that we do this, since the FDA eCTD guidances don’t speak specifically to this issue. For the record, we collapse the bookmarks in every document in order to provide a consistent look from document to document throughout the application. One of our goals is always to create a positive user experience for the FDA reviewer, and ensuring that the reviewer encounters the same interface every time is big part of that.
Recently, this same question was raised in a discussion during a meeting of the GlobalSubmit Suite 2010 Beta Test group. Kathie Clark took advantage of GlobalSubmit‘s close ties with the FDA and took the question directly to the Agency. She learned that:
- CBER has been giving feedback in response to sample submissions that they would prefer to see bookmarks collapsed.
- CDER has not expressed a preference.
- No written guidance has been issued beyond what is included within the ICH eCTD Specification v3.2.2 (see page 7-4).
- FDA does not deem this issue as important enough for GlobalSubmit to include a check for it in the upcoming version of VALIDATE™.
Does your organization have a preference on whether bookmarks are collapsed or expanded? If so, what is your rationale?
Related articles:
- GlobalSubmit Suite 2010 Beta Test – Part 1 (ask-cato.com)
- FDA Reviewer Survey: CTD/eCTD Quality (theectdsummit.com)
- Top FDA Processing Issues with eCTD: A Recent Update (theectdsummit.com)
- Advice from Evan Richardson, Cato Director of Reg Ops, for Sponsors New to eCTD (theectdsummit.com)
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Hi,
Personnaly I have asked our eCTD publisher to expand the bookmarks (up to the 3rd level) so that the Agencies reviewer don’t have to expand them for each document. Indeed I thought this action would get tiresome in the long run for the reviewer.
Thanks for your reply Florence. I agree that it could be annoying for a reviewer to always have to expand the bookmarks. However, I can also imagine that, especially for larger documents, an expanded list of bookmarks could be so long as to make it cumbersome to find a specific bookmark. Since there is no official guidance on this, I think it comes down to personal (or organizational) preference, and there is no wrong way to do it as long as you are consistent.
I agree with richardson these expanding and collapsing the book marks based on the organizational preference. Some companies they are prefer to expended format some others prefer to collapsed format of bookmarks.
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