Hyperlinking in eCTD Submissions FAQs

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The questions and concerns surrounding hyperlinks in eCTD submission are numerous. Over the last several years, I’ve collected a number of these questions. Below is a short list of the most frequently asked ones.

  • How many links should I have?
  • Can I have too many links?
  • Should the table of contents have hyperlinks?

While the FDA has posted the Portable Document Format Specifications document which provides numerous best practices for PDF documents, it does not address how reviewers perceive hyperlinks in your submission.

During several presentations, representatives from the FDA have conveyed some clear messages concerning hyperlinks. The general takeaway is that hyperlinks are very important to the review process as they maximize the usefulness of receiving an eCTD submission. That being said, there are not too many things worse than submitting hyperlinks that go to the wrong document or the wrong page within a document. Even worse are links that simply do not work. These types of linking issues erode the reviewer’s confidence in the submission.

While I have often heard from reviewers that submissions do not contain enough hyperlinks, there have been several occasions where there are too many links. These are extreme cases in which there are nearly as many links as there are sentences in a document. Overall, you should err on the side of more hyperlinks as long as they enhance navigation, highlight important information and speed up the review process. One pet peeve of reviewers is the scanned document because they typically are not searchable, and they do not contain useful hyperlinks.

A few other hyperlinking items worth highlighting:

  • Module 2 should contain plenty of links to supporting documents in Modules 3 – 5.
  • The table of contents of a document should contain hyperlinks to the corresponding sections within the document.

For additional information, you can refer to a recent presentation titled eCTD: A Clinical Reviewer’s Experience Disclaimer from Sarah M. Connelly, MD.

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Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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