Most eCTD publishing systems now come with tools to simplify the process of inserting and updating cross-document hyperlinks. These tools generally work well, save time, and enable publishers to incorporate late content changes without having to redo all their links.
So what's the problem?
Did you ever get lost in a book with too many footnotes?Just because you can easily insert hyperlinks doesn't mean it's a good idea. The more links you have on a page, the harder it is to read. The blue text or underlines are distracting, and if the reader has to constantly jump back and forth to understand the content they will lose track of the narrative. Besides, reviewers already know the eCTD structure, and submission viewers make it easy to navigate between documents without hyperlinks. At their worst, excessive hyperlinks distract the reader and could lead them inadvertently to a topic you may not want to call their attention to.
Here are a few guidelines I recommend to authors for cross-document hyperlinking. Think about them and see if you can apply them to your business process:
- Only insert a hyperlink if the material you're linking to clearly enhances the reader's understanding of what you're saying.
- Don't insert general-sounding links. For example, don't say, "The results of the study can be found in the study report" and insert a link on the words study report. Anybody reading your document should know that the results of the study are written up in the report--that link won't help them understand what you're telling them.
- If there is specific information outside your document that's relevant to what you are writing, like a figure, table, or discussion of results, link to that specific item.
- Resist the temptation to link every instance of a keyword, like a patient number or section number. These keywords often appear many times on the same page, and distract the reader. I find patient number links especially challenging, because, depending on the context, they could target a case report form, patient narrative, or patient profile; linking to the wrong one could be worse than not linking at all.
Try to develop a strategy of minimal links and train authors to use restraint. It's helpful to demonstrate eCTD viewers so that the authors realize how easy it is for reviewers to find different sections of the submission without all the extra links. Even with automatic tools, hyperlinking is very labor intensive. Links have to be verified and the final content QC'd. Every link you don't insert saves time and money.